221 Clinical Trials for Various Conditions
This trial is to study a new breast imaging tool called Thermalytix™. ThermalytixTM is a new radiation-free, automated breast cancer screening technique that uses Artificial Intelligence (AI) over thermal images. Thermal images are heat signatures in our body. This new technique will capture heat signatures in the breast and analyze those images with AI software. This study will evaluate the performance of ThermalytixTM breast imaging against standard imaging modalities, such as mammography and ultrasound.
Breast tumors are often detected on mammography but may be harder to see in women with dense breasts. This is why screening breast ultrasound is sometimes used as another test in women with dense breasts. Ultrasound has been shown to detect additional cancers that are not seen on regular mammography. Contrast Enhanced Digital Mammography (CEDM) is a FDA approved form of mammography. It is essentially a routine digital mammogram performed after iodine dye (the same that is used with CT scans) is injected into a vein in the arm. Like screening ultrasound, CEDM has been shown to detect breast cancers that are not seen on a regular mammogram. The purpose of this study is to compare whether CEDM or screening breast ultrasound is better at detecting cancer. Both will be done in this study and compared to one another.
The purpose of this study is to determine whether ultrasound or Digital breast tomosynthesis (DBT) detects more cancers and to compare the types of cancers detected on ultrasound and DBT.
This is a prospective, single-center image case collection study to acquire de-identified contrast-enhanced breast images on the Investigational Device to support continuing technology development. Eligible subjects include women at least 35 years old with a suspicious finding or breast abnormality on a screening or diagnostic mammogram who are indicated for a diagnostic exam or a biopsy procedure.
This study will test the iBreastExam device to find out whether it can detect a mass or lump in the breast as accurately as a routine breast cancer screening examination. The iBreastExam is a handheld device that performs a painless electronic palpation (examination by touch) of the breast. The device is designed to detect breast abnormalities that may require breast imaging and additional clinical examination by a nurse or doctor. The iBreastExam device creates a color map of the breast, with red spots indicating areas that may be abnormal.
The purpose of this study is to test whether contrast-enhanced spectral mammography (CESM) may be able to reduce the number of unnecessary biopsies in women whose screening mammograms had abnormal findings.
The purpose of this study is to evaluate potential clinical efficacy of a novel magnetic resonance imaging (MRI) approach, MR fingerprinting, capable of providing quantitative measures of important tissue properties, which could provide important insights into normal breast tissue. This new MRI sequence will be added to the screening breast Dynamic Contrast Enhanced (DCE) MRI for high risk normal patients.
This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment.
The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in women with dense breast parenchyma. This reader study will include up to 32 radiologist readers and a sample of 140 breast screening cases that were selected from the library of images collected under Delphinus Protocol #DMT-2015.001 (NCT03257839) Arm 1 Phase B. The reader study image case set will be enriched with cancer cases.
The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in women with dense breast parenchyma. This reader study will include approximately 32 radiologist readers and a sample of approximately 200 breast screening cases to be selected from the library of images collected under Delphinus Protocol #DMT-2015.001 (NCT03257839) Arm 1 Phases B, C, and D. The reader study image case set will be enriched with cancer cases.
The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in women with dense breast parenchyma. This includes obtaining information that can be used to properly plan, design, and power future ROC reader studies. This reader study will include a minimum of 6 radiologist readers and an enriched sample of at least 100 breast screening or diagnostic cases to be selected from the library of images collected under Delphinus Protocol #DMT-2015.001 (NCT03257839). The reader study image case set will be enriched with cancer cases.
The SoftVue™ is a whole breast ultrasound system with an automated scanning curvilinear ring-array transducer that employs UST. It is currently cleared under FDA 510(k) K123209 and K142517 for use as both a B-mode ultrasonic breast imaging system and color imaging of transmission data (sound speed and attenuation). SoftVue™ is not intended to be used as a replacement for screening mammography. SoftVue uses non-ionizing ultrasound energy to generate tomographic image volumes of the whole breast. While the patient lays prone on a padded table with one breast comfortably submerged in a bath of warm water, a ring-shaped transducer, 22 cm in diameter, encircles the breast and pulses low-frequency sound waves through the water and into the breast tissue. More than 2000 elements in the curvilinear transducer's 360 degree array emit and receive ultrasound signals to analyze echoes from the breast anatomy in all directions, from the chest wall to the nipple. Not only does SoftVue capture data from the reflection of the sound waves off of tissue boundaries and structures within the breast, but because the transducer surrounds the whole breast, SoftVue also captures signals that are transmitted through the breast. This additional transmission data enhances the visualization of the anatomic structure of the breast tissue and is not currently available in any other commercially marketed breast ultrasound device. This prospective, multicenter, multi-arm, clinical case collection program is IRB-approved and will be conducted in compliance with Good Clinical Practice, the Declaration of Helsinki and all applicable regulatory requirements. Arm 1 aims to collectively enroll up to 17,500 women at a total of up to 8 clinical sites. The design of this protocol is strictly limited to case collection; all investigational and statistical plans for future analyses will be prepared and registered separately, if they are applicable to the requirements of FDAAA 801. Arm 1 is limited to the cohort of asymptomatic women, with heterogeneously or extremely dense breast parenchyma (BI-RADS breast composition category c or d). Matched triads of 2D digital mammography (FFDM), 3D digital mammography (DBT), and SoftVue automated whole breast ultrasound (SV)exams, from the same patient, with demographic information and clinical outcome data, will be collected during the same screening imaging episode. Ultrasound characteristics for all types of lesions, whether they are benign or malignant, will be collected, as well as objective and subjective breast density composition data. The exams and clinical data accumulated in this prospective case collection (PCC) protocol will populate a database from which future investigations may be designed for peer reviewed publication, development of user training curriculums, building teaching case, and creating new marketing materials for SoftVue.A subset of exams will be sampled from Arm 1 for use in ROC Reader Study (protocol DMT-2015.002), which will be separately registered and is designed to evaluate the safety and efficacy of a new screening indication for use of SoftVue™ as an adjunct to screening mammography. The results of this ROC Reader Study will be submitted to the FDA for their consideration of a PMA application for SoftVue.
The SoftVue™ is a whole breast ultrasound system with an automated scanning curvilinear ring-array transducer that employs UST. It is currently cleared under FDA 510(k) K123209 and K142517 for use as both a B-mode ultrasonic breast imaging system and color imaging of transmission data (sound speed and attenuation). SoftVue™ is not intended to be used as a replacement for screening mammography. SoftVue uses non-ionizing ultrasound energy to generate tomographic image volumes of the whole breast. While the patient lays prone on a padded table with one breast comfortably submerged in a bath of warm water, a ring-shaped transducer, 22 cm in diameter, encircles the breast and pulses low-frequency sound waves through the water and into the breast tissue. More than 2000 elements in the curvilinear transducer's 360 degree array emit and receive ultrasound signals to analyze echoes from the breast anatomy in all directions, from the chest wall to the nipple. Not only does SoftVue capture data from the reflection of the sound waves off of tissue boundaries and structures within the breast, but because the transducer surrounds the whole breast, SoftVue also captures signals that are transmitted through the breast. This additional transmission data enhances the visualization of the anatomic structure of the breast tissue and is not currently available in any other commercially marketed breast ultrasound device. This prospective, multicenter, multi-arm, clinical case collection program is IRB-approved and will be conducted in compliance with Good Clinical Practice, the Declaration of Helsinki and all applicable regulatory requirements. Arm 2 aims to collectively enroll up to 1,000 women at a total of up to 8 clinical sites. The design of Arm 2 in this protocol is strictly limited to case collection and is non-interventional; any investigational and/or statistical plans for future analyses will be prepared and registered separately, if they are applicable to the requirements of FDAAA 801. Arm 2 is limited to the cohort of diagnostic female patients of any breast density composition category, who have been recommended for a breast biopsy (BI-RADS 4 or 5) after diagnostic imaging, or who have confirmed imaging findings. Matched sets of diagnostic imaging and SV exams, from the same patient, demographic information, and clinical outcome data, will be collected during diagnostic workup. Ultrasound characteristics for all types of lesions, whether they are benign or malignant, will be collected as well as objective and subjective breast density composition data. Ultrasound image data may be acquired with modified SoftVue devices, which have passed safety and quality evaluations per Delphinus' quality management system (QMS) and satisfy design change control standards, at select clinical sites in accordance with 21 CFR 812.2 (b), as a routine part of feasibility, validation, and verification testing for engineering and product development purposes. The exams and clinical data accumulated in this prospective case collection (PCC) protocol will populate a database from which future investigations may be designed for peer reviewed publication, development of user training curricula, building teaching case, and creating new marketing materials for SoftVue.
Most physicians still use a one-size-fits-all approach to breast screening in which all women, regardless of their personal history, family history or genetics (except BRCA carriers) are recommended to have annual mammograms starting at age 40. Mammograms benefit women by detecting cancers early when they are easier to treat, but they are not perfect. Recent news stories have discussed some of the potential harms: large numbers of positive results that cause stressful recalls for additional mammograms and biopsies. With the current screening approach, half of the women who undergo annual screening for ten years will have at least one false positive biopsy. Potentially more important are cancer diagnoses for growths that might never come to clinical attention if left alone (called "overdiagnosis"). This can lead to unnecessary treatment. Even more concerning is evidence that up to 20% of breast cancers detected today may fall into the category of "overdiagnosis." This study compares annual screening with a risk-based breast cancer screening schedule, based upon each woman's personal risk of breast cancer. The investigators have designed the study to be inclusive of all, so that even women who might be nervous about being randomly assigned to receive a particular type of care (a procedure that is typical in clinical studies) will still be able to participate by choosing the type of care they receive. For participants in the risk-based screening arm, each woman will receive a personal risk assessment that includes her family and medical history, breast density measurement and tests for genes (mutations and variations) linked to the development of breast cancer. Women who have the highest personal risk of developing breast cancer will receive more frequent screening, while women with a lower personal risk would receive less frequent screening. No woman will be screened less than is recommended by the USPSTF breast cancer screening guidelines. If this study is successful, women will gain a realistic understanding of their personal risk of breast cancer as well as strategies to reduce their risk, and fewer women will suffer from the anxiety of false positive mammograms and unnecessary biopsies. The investigators believe this study has the potential to transform breast cancer screening in America.
The purpose of this study is to measure the performance characteristics for the collection, fixation and transportation of clinical nipple aspirate fluid (NAF) specimens of the ForeCYTE Breast Aspirator across 3 independent labs and the National Reference Laboratory for Breast Health (NRLBH). The study hypothesis is that each lab will have a specimen acceptability rate of at least 90%. If it is assumed that the true level of acceptability testing is approximately 96%, then the lower bound of a one-sided 95% confidence interval is expected to be at least 90%.
The purpose of this study is to determine if Contrast Enhanced Spectral Mammography (CESM) will be able to detect smaller/earlier breast cancers as well as breast MRI can.
To determine the impact on Interpreting Physician performance in detecting breast cancer, as defined by the area under the Receiver Operating Characteristic Curve (ROC), when Automated Breast Ultrasound (ABUS) and screening mammography (XRM) are combined, compared to screening mammography alone in asymptomatic women with \>50% parenchymal density and a screening mammogram assigned a BI-RADS Assessment Category 1 (negative) or 2 (normal with benign findings). The effect of the improved Reader performance is illustrated by plotting the ROC curves for XRM alone and XRM+ABUS. If Reader performance improves with the addition of ABUS to the XRM, the area under the curve (AUC) for XRM+ABUS (AUCXRM+ABUS) will be greater than the area under the curve for XRM Alone (AUCXRM Alone). This difference is represented as ∆AUCABUS. The null and alternative hypotheses can be formally expressed as follows: H0: ∆AUCABUS = 0, AUCXRM+ABUS = AUCXRM Alone The null hypothesis is that Reader performance will be unchanged with the addition of ABUS to a screening mammogram assigned a BI-RADS Assessment Category of 1 or 2. HA: ∆AUCABUS ≠ 0, AUCXRM+ABUS ≠ AUCXRM Alone The alternative hypothesis is that Reader performance will be changed with the addition of ABUS to a screening mammogram assigned a BI-RADS Assessment Category of 1 or 2. A statistically significant change will be considered equivalent to a statistically significant improvement if the estimated value of AUCXRM+ABUS is greater than that of AUCXRM Alone with statistical significance at an alpha level of .05 for a two-sided test.
This project evaluates the impact of CHESS-Mammo by assessing participants' health information competence, psychological distress, and satisfaction with their doctor as measured by previously validated survey questionnaires.
Hypothesis: A higher sensitivity to breast cancer detection can be achieved in women with dense breast tissue by performing and reviewing results of Automated Breast Ultrasound (ABUS) and Digital X-Ray Mammography (XRM) together as part of routine screening compared to performing and reviewing results of XRM alone. Primary Objective: For the cohort of asymptomatic women who have dense breast tissue, calculate the sensitivity of Digital X-Ray Mammography (XRM) and ABUS together as a breast cancer screening modality and compare it to that of XRM alone. Secondary Objective: For the cohort of asymptomatic women who have dense breast tissue, evaluate the specificity of XRM and ABUS together compared to that of XRM alone; Calculate the negative predictive value (NPV) and positive predictive value (PPV) for XRM and ABUS. Endpoint: Breast cancers detected by radiologists in the clinical screening setting and confirmed by pathology. Study Design: This is a prospective matched-pair clinical study enrolling more than 20,000 women with parenchymal density \> 50% on digital x-ray mammography (XRM). Participants will receive ABUS as an adjunct to XRM. Any abnormal findings, from either XRM or ABUS, will receive appropriate management action consistent with accepted medical standards of care. All evaluation results, diagnosis and treatment outcomes will be recorded. Participants will be followed for one year and those who are not diagnosed with breast cancer at enrollment or during the follow-up interval must undergo an annual mammogram at study completion, the outcome of which will be recorded.
The purpose of this study is to determine if the use of breast MRI in detecting breast malignancies in survivors of Hodgkin's disease is more successful than the traditional mammogram.
The goal of this clinical trial is to compare patient-centered outcomes when 3D screening mammograms are interpreted with versus without a leading FDA-cleared AI decision-support tool in real-world U.S. settings and to assess patient's perspectives on AI in medicine. The main questions it aims to answer are: 1. Will AI use be associated with an increase in cancer detection and an initially higher recall rate as radiologists start using AI, followed by a recall rate comparable to that without AI (no more than 1.5 percentage-points higher) after a learning curve period? Will AI use will be associated with lower rates of missed breast cancers and similar rates of false alarms after a learning curve period? 2. Will improved patient outcomes with AI be most pronounced for exams on women who are White, older, and have less dense breasts, and on baseline exams? Will AI aid patient outcomes when the interpretation is by radiologists with less clinical experience, lower annual interpretive volume, and less tolerance of ambiguity? Yet, will there be greater automation bias (the tendency for humans to defer to a computer algorithms' results) noted among these radiologists? 3. What are patients' perspectives on AI in mammography, including their confidence in breast cancer screening when interpreted with vs. without AI? What are patients' perspectives on the importance of the study results? Researchers will compare patient-centered outcomes when 3D screening mammograms are interpreted with versus without a leading FDA-cleared AI decision-support tool in real-world U.S. settings. This trial will include all adult patients undergoing 3D mammography breast cancer screening at imaging facilities across University of California at Los Angeles and University of Washington health systems and all radiologists interpreting breast cancer screening. All screening mammograms at these facilities will be randomized to either intervention (radiologist with AI support) versus usual care (radiologist alone) to see if interpreting these mammograms with the AI tool's assistance improves patient outcomes.
This investigation is a prospective breast cancer screening study open to all transgender and gender-diverse persons (regardless of sex assigned at birth). Using a mixed methods approach, the study will 1) gather prospective quantitative breast imaging data in conjunction with gender-affirming therapy and family cancer history and 2) investigate TGD persons perceptions and experiences in the breast cancer screening program, and 3) identify individual and systems-level barriers to breast cancer screening.
The goal of this study is to evaluate if adding community services navigation to the standard referral process for social needs is an effective and scalable strategy for addressing disparities in follow-up to abnormal breast cancer screening results. The investigators will determine the effectiveness of social needs referrals combined with a community services navigation intervention in the screening mammography setting to improving breast screening outcomes in underserved women.
Brief Summary A task like breast cancer screening (mammography) can be described as a "hybrid search" task. In basic visual search tasks, observers search for a target among distractors that are not the target. In hybrid search, observers search for two or more target types. In mammography, observers are searching for masses, calcifications ("calcs"), and some other signs of cancer like architectural distortion. In this experiment, the investigators have created a simulated version of mammography where non-expert (non-radiologist) observers can look for simulated masses and calcs. There are two types of stimuli, a 2D version (like an x-ray) and a 3D version (like the output of Digital Breast Tomosynthesis - DBT). The question that is being asked is whether it is better to ask about masses and calcs separately (first one, then the other) or to just let observers look for both at the same time.
All participants will read a decision aid (DA) communicating evidence about mammography screening benefits and harms. Participants' evaluations of that evidence will be assessed, along with their screening intentions and receipt of screening. Participants will be sent 3 surveys via email and a final brief survey conducted by email or phone. The four surveys will be collected 1) upon enrollment and prior to the primary care appointment; 2) following the primary care appointment; 3) 3 months after enrollment; 4) 1 year after enrollment. The final 2 surveys will offer an increased incentive to increase retention rates.
The goal of this study is to increase MRI utilization among women with extremely dense breasts. The main question it seeks to answer is whether nudging of the provider, patient, or both increases the uptake of MRI among this group, and whether this effect differs between Black and White women.
To learn whether a new imaging technology, Contrast-Enhanced Mammography (CEM), compared to standard mammography, can better detect breast cancers in women with dense breasts
The goal of this study is to evaluate the relative benefits of an intervention to promote breast cancer screening among women in the White Mountain Apache (WMA) community. Women will be randomized to receive CARE, a culturally tailored mammography education module, or CARE+COACH, which is the CARE education module plus access to an Apache paraprofessional women's health coach (i.e., patient navigator). The CARE intervention was developed through a community-based participatory research process. The primary outcome is mammography uptake within 2 months of a referral.
The over-arching goal of the Contrast-Enhanced Spectral Mammography Imaging Screening Trial (CMIST) is to determine if dual-energy contrast-enhanced spectral mammography (CESM) can detect more cancers with fewer false positives than digital breast tomosynthesis (DBT) in women with dense breasts. Aim 1: To evaluate the performance of CESM compared to DBT at baseline for breast-cancer screening in women with dense breasts. Aim 2: To evaluate the performance of CESM compared to DBT at the 1-year follow up for breast-cancer screening in women with dense breasts.
Our objectives in this project are to develop and evaluate the feasibility and effectiveness of the Mobile Web App Breast Cancer Screening (wMammogram) intervention that is culturally tailored for AI women residing in rural areas. The proposed study will be a multi-method, two-phase research project that will take place in South Dakota over a three-year period. The two phases are: (1) developing the wMammogram intervention and (2) evaluating the feasibility and efficacy of the wMammogram. Phase 1 incorporates a community-based participatory research approach and a series of focus groups with various stakeholders in American Indian (AI) communities to design a culturally informed and practically refined intervention. Phase 2 uses a randomized clinical trial (RCT) design with AI women. The wMammogram intervention will be applied throughout a seven-day period, with assessment at three intervals: baseline (survey), one-week post-intervention (survey), and six-month follow-up (telephone survey). The wMammogram intervention will be implemented with AI women using the two-arm RCT that includes recruiting a total of 120 AI women aged 40 to 70 years and randomly assigning them to either (a) the wMammogram intervention group (n=60) to receive culturally and personally tailored multilevel and multimedia messages through a Mobile Web App along with health navigator services or (b) the control group (n=60) to receive the mailing of printed educational materials on breast cancer and relevant screening guidelines along with health navigator services. Hypotheses: In assessing the efficacy and feasibility of the wMammogram, Investigators hypothesize that: (H1)The wMammogram intervention participants will show a higher rate of mammograms received than will participants in the educational materials intervention. (H2)The wMammogram intervention participants will show improvements in knowledge, attitude, and beliefs about breast cancer screening and readiness for mammography as compared to participants in the educational materials intervention. (H3)The wMammogram intervention participants will demonstrate greater satisfaction with and acceptance of the intervention than would participants in the educational materials intervention.