Treatment Trials

247 Clinical Trials for Various Conditions

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RECRUITING
OCT Angiography and NRAI in Dementia
Description

The primary goals of this study are to use optical coherence tomography (OCT) angiography (blood vessel mapping) to: 1. Detect retinal blood vessel and blood flow changes in participants with dementia. 2. Detect amyloid protein deposits in the retinas of participants with dementia.

COMPLETED
Academic-Industrial Partnership for Translation of Acoustic Angiography
Description

Purpose: The primary objective of this single arm study is to compare the sensitivity and specificity of acoustic angiography with traditional b-mode ultrasound in the distinction of malignant versus benign breast lesions. Secondary objectives include a comparison of area under the curve (AUC) for acoustic angiography versus b-mode ultrasound, and comparison of radiologist preference for the two imaging techniques for each of 3 lesion characteristics. Participants: Sixty patients who are to have a clinical surgical breast biopsy based on results from pre-study standard of care (SOC) imaging will be recruited from the UNC Breast Clinic for participation in the study. Procedures (methods): This is a one arm single center study of patients with suspicious breast lesions (BIRADS 4 or 5) from the UNC Breast Clinic that consent to undergo an acoustic angiography in conjunction with b-mode ultrasound prior to their scheduled biopsy.

SUSPENDED
Fluorescein Angiography With a Full-dose Versus a Half-dose of Intravenous Fluorescein
Description

Fluorescein angiography is a common procedure used in ophthalmology to diagnose and monitor diseases of the eye. The standard dose of fluorescein dye used in fluorescein angiography is 500mg. It is common practice to give patients who have previously had an adverse reaction to fluorescein dye a half-dose, or 250mg, of fluorescein. It has been determined by our institution that anecdotally, there is no difference in image quality between the images created by a half-dose of fluorescein versus a full dose of fluorescein. Therefore, this study seeks to determine whether these doses are actually equivalent in terms of image quality. Patients who consent to participate in the study will be randomized to receive either a half or a full dose of intravenous fluorescein, and their images will be compared subjectively using a masked team of retinal surgeons and residents. We hypothesize that there will be no significant difference between the images obtained using a half-dose versus a full dose of intravenous fluorescein.

TERMINATED
SD-OCT Angiography
Description

The objective of this study is to image retinal vascular alterations in patients with retinal disease using the AngioVue OCT-A system and understand the information these images provide. The investigators will image study participants who have retinal diseases with the AngioVue unit (Optovue) and will collect relevant clinical data to understand the nature of the information contained in images obtained on AngioVue. This study being conducted under an abbreviated IDE. The investigators will analyze data using descriptive statistics. Risks related to light exposure will be managed by ensuring that the exposure to the AngioVue light source is well below maximum permissible limits for safe exposure.

RECRUITING
OCT Angiography in Wet AMD
Description

The primary goals of this study are to use optical coherence tomography (OCT) angiography (blood vessel mapping) to: 1. diagnose the presence of new blood vessels in wet age-related macular degeneration (AMD) 2. evaluate patients undergoing treatment for wet AMD 3. determine if reduced flow to the choroid is a risk factor for developing wet AMD.

COMPLETED
Comparison of the Sensitivity and Specificity of Acoustic Angiography to the Sensitivity and Specificity of Conventional Ultrasound
Description

Purpose: This study will evaluate a new ultrasound imaging technology called acoustic angiography. Acoustic angiography uses an ultrasound contrast agent, already FDA approved for use in cardiology, to enhance imaging of blood vessels. Since acoustic angiography uses ultrasound, and not x-rays, the patient is not exposed to ionizing radiation, unlike traditional angiography and mammography. Specific goals will be to evaluate the quality of the images provided by acoustic angiography in the human breast, and furthermore to evaluate whether or not acoustic angiography provides additional diagnostic information over traditional ultrasound which could provide an improvement in assessing breast lesions. Specifically, this additional diagnostic information will hopefully enable us to reduce false positive tests and discriminate lethal cancers from non-lethal disease. Participants: The investigators are recruiting 60 patients from the UNC Breast Clinic who are undergoing core needle biopsy or surgical biopsy (BIRADS 4 and 5 breast lesions). Procedures (methods): Acoustic Angiography imaging will be performed in conjunction with standard diagnostic imaging, including b-mode ultrasound . Then, a reader study will be conducted to compare these modalities. Finally, the images will be analyzed with image processing techniques to determine quantitative metrics exhibited by the blood vessel morphology in the images. These metrics will be utilized to develop a "malignancy score" equation to predict malignancy of a lesion.

UNKNOWN
Trial Comparing Angiography and Angiography With IVUS for Treatment of Hemodialysis Access Failures
Description

The reason the investigators are doing this study is to compare the results of angiography versus angiography with intravascular ultrasound in dialysis grafts/fistulas that are blocked.

TERMINATED
Comparison of Phase-variance Optical Coherence Tomography and Fluorescein Angiography in Retinovascular Imaging
Description

The purpose of this study is to determine whether phase variance optical coherence tomography (PV-OCT), a software-based optical coherence tomography(OCT) image processing technology, can be used to generate angiographic images of the retinochoroidal vasculature that are comparable to those produced by fluorescein angiography (FA), the current gold standard diagnostic test.

TERMINATED
Application of Indocyanine Green Angiography for Closed Operative Calcaneus Fractures
Description

Researchers in the Orthopaedic surgery department at LSU Medical Center-Shreveport hope to learn if patterns of blood-flow around the incision site of patients undergoing surgery for heel-bone fractures can help predict whether complications will arise after a specific type of operation.The goals of this research study are to effectively answer as many of the following research questions as possible: 1. Can a drug normally used to evaluate adequate blood flow in plastic surgery and tissue transfer be used to identify altered patterns of blood flow at the operative site of Calcaneus fractures, when compared to the uninjured extremity? 2. Are changes in blood flow identifiable at the operative site post operatively? 3. Are there certain patterns of blood flow present preoperatively or postoperatively that can predict wound complication? 4. Can certain patterns of blood flow predict the location of slough or dehiscence after surgery? 5. Does the incision site and its proximity to specific patterns of blood flow possibly predict wound complication? The hypothesis is that the study drug will show a correlation between certain patterns of blood flow and whatever post-operative complications may arise.

COMPLETED
Combined Non-invasive Coronary Angiography and Myocardial Perfusion Imaging Using 320 Detector Computed Tomography
Description

The purpose of this study is to evaluate the diagnostic accuracy of multi-detector computed tomography using 320 detectors for identifying the combination of coronary artery stenosis ≥ 50% and a corresponding myocardium perfusion defect in a patient with suspected coronary artery disease compared with conventional coronary angiography and single photon emission computed tomography myocardium perfusion imaging.

TERMINATED
Safety and Effectiveness of Visipaque 320mg-I/ml for Use in Contrast-Enhanced CT Angiography of Arteries of the Heart
Description

CT (computed tomography) angiography (CTA) is an examination similar to a CAT scan that uses x-rays and a contrast medium (also called dye) to visualize blood flow in arteries and veins throughout the body VISIPAQUE™ will be given through a vein in the arm before having the CTA scan of the heart arteries. The pictures it produces of the heart and its blood vessels will be reviewed and compared to those obtained during the catheter-based coronary angiography to see if the CTA shows the same blockages.

TERMINATED
Safety and Effectiveness of Visipaque 320mg-I/ml for Use in Contrast-Enhanced CT Angiography of Arteries of the Heart
Description

CT (computed tomography) angiography (CTA) is an examination similar to a CAT scan that uses x-rays and a contrast medium (also called dye) to visualize blood flow in arteries and veins throughout the body. VISIPAQUE™ will be given through a vein in the arm before having the CTA scan of the heart arteries. The pictures it produces of the heart and its blood vessels will be reviewed and compared to those obtained during the catheter-based coronary angiography to see if the CTA shows the same blockages.

NOT_YET_RECRUITING
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients with Large Vessel OCclusion in the Angiography SuiTe
Description

The purpose of this study is to compare two strategies for treating adults with suspected large vessel occlusion stroke within 7 hours of symptom onset. Researchers will evaluate whether direct transfer to the neurointerventional angiography suite improves recovery and reduces disability compared to the conventional approach of first being evaluated in the emergency department. The study will also assess safety and other health outcomes to guide care for stroke patients.

Conditions
RECRUITING
Optical Coherence Tomography Angiography in Neurological Disease
Description

Optical Coherence Tomography Angiography (OCTA) is a non-invasive tool that images the neurovascular structures of the eye by using near-infrared light. Previous literature has demonstrated the potential of OCTA as a screening tool in stroke, but its utility in other neurological illness such as intracranial hemorrhage is unclear. Hence, this pilot study will gather preliminary data to support future grant applications to investigate this area more fully by recruiting patients with neurological illness and healthy controls and comparing their OCTA imaging parameters.

NOT_YET_RECRUITING
Bacterial Decolonization Plus Intraoperative Angiography for Soft Tissue Sarcomas Receiving Preoperative Radiotherapy (CONCERTO)
Description

This trial will investigate the combination of two low-cost, non-toxic strategies to assess whether they can reduce the risk of acute major wound complications in soft tissue sarcoma of the lower extremity. Intranasal mupirocin ointment twice daily and chlorhexidine body cleanser once daily for 5 days prior to radiation therapy and repeated for 5 days every 2 weeks during radiation therapy may significantly reduce the risk of acute radiation dermatitis. That, along with use of indocyanine green (ICG) angiography at the time of wound closure.

NOT_YET_RECRUITING
Indocyanine Green Fluoroscopy and SPY Angiography for the Assessment of Lymphatic Structure in Breast Cancer Patients at Risk for Breast Cancer-Related Lymphedema
Description

This clinical trial assesses the change in lymphatic structure from placement of an intravenous (IV) line and fluid administration using a diagnostic agent, indocyanine green (ICG), with SPY (Trademark) angiography in breast cancer patients at risk for breast cancer-related lymphedema (BCRL). Patients that are diagnosed with breast cancer with lymph node involvement often undergo treatment that includes surgery to remove the axillary nodes and radiation. Unfortunately, this procedure increases the incidence of BCRL in the surgical arm, as well as other problems including heaviness of the arm, fibrotic skin changes, and an increase in infection risk. Because of these symptoms, venipuncture (blood draw) is often avoided in these arms. Researchers want to show that placement of an IV line and fluid administration in patients at risk for BCRL will indeed not alter the lymphatic structure of the arm and will not change the incidence of BCRL by administering indocyanine green (ICG) dye to patients and assessing their arm lymphatics. ICG is a fluorescent dye that is able to be visualized by the SPY angiography imaging system as it travels through the lymphatic system, allowing researchers to assess how well blood flows throughout the body. Receiving ICG and undergoing SPY angiography may be effective in showing that placement of an IV and fluid administration in breast cancer patients at risk for BCRL will not alter the lymphatic structure of their arm and will not change the incidence of BCRL.

RECRUITING
Evaluation of Tumor Resection Guided by Intraoperative Indocyanine Green Dye Fluorescence Angiography in Patients With Sarcoma
Description

This study evaluates the effectiveness of intraoperative indocyanine green dye and fluoroscopic technology in confirming negative margins after tumor removal.

RECRUITING
Improvements in Dynamic Contrast-Enhanced MR Angiography and Perfusion and Non-Contrast MRI
Description

This study evaluates if technical improvements in MRI can be used to provide improved performance contrast-enhanced MRI as used for angiography and perfusion as well as in non-contrast MRI.

WITHDRAWN
Evaluation of Neuroma Perfusion with Indocyanine Green Fluorescence Angiography
Description

The purpose of this study is to characterize the perfusion of neuromas using indocyanine green fluorescence angiography

NOT_YET_RECRUITING
Ultra-Low Contrast Angiography in AKI
Description

The aim of this study is to evaluate the safety of ultra-low contrast coronary angiography in patients with pre-existing acute kidney injury.

RECRUITING
Comparison of ICG Microangiography and Conventional Angiography in Severe Frostbite
Description

Severe frostbite injury is a significant cause of morbidity in northern climates. Minnesota has some of the highest numbers of severe frostbite injuries in North America. As a result, Regions Hospital has the best opportunity to study this disease process and improve outcomes for frostbite patients. The diagnostic methods for severe frostbite injury vary from institution to institution and there is no standard practice. Commonly utilized methods include conventional angiography, Technetium 99 triple phase bone scans, SPECT studies, Indocyanine Green microangiography, and doppler studies. The proposed pilot study aims to directly compare conventional angiography imaging to ICG microangiography in adult patients with severe frostbite. Severe frostbite is defined as 4th degree: frostbite resulting in vascular occlusion and tissue ischemia. Both imaging modalities have been used for the diagnosis and monitoring of severe frostbite injury but there has never been a study directly comparing these two imaging modalities.

Conditions
RECRUITING
Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease
Description

COMPLETE-2 is a prospective, multi-centre, randomized controlled trial comparing a strategy of physiology-guided complete revascularization to angiography-guided complete revascularization in patients with acute ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease (CAD) who have undergone successful culprit lesion Percutaneous Coronary Intervention (PCI). COMPLETE-2 OCT is a large scale, prospective, multi-centre, observational, imaging study of patients with STEMI or NSTEMI and multivessel CAD in a subset of eligible COMPLETE-2 patients.

ACTIVE_NOT_RECRUITING
Comparing Electrical Impedance Tomography to Computed Tomographic Angiography
Description

The study aim is to determine whether electrical impedance tomography (EIT) is equivalent in the detection of pulmomary emboli compared to Computed Tomographic Angiography (CTA). EIT is a non-invasive, non-ionizing functional imaging technique that can be performed at bedside. Electrical impedance tomography data will be collected on individuals undergoing a CTA scan of the chest at Medical Center of the Rockies (MCR). The primary outcome measure is to assess whether assessment by CTA corresponds with EIT in detection of pulmonary emboli. The study will include up to 63 participants. EIT data will be collected for up to 20 minutes during tidal breathing and for approximately five to ten seconds during breath-holding.

WITHDRAWN
SPY Angiography To Assist With Ulnar Nerve Transposition at the Elbow
Description

Patients with vascular disease, thyroid disease or an allergy to indocyanine green (ICG) will be excluded. Patients with either median or ulnar nerve compression will be treated with nerve decompression. SPY angiography will be used to assess the vascularity of the nerve both pre and post release as the primary outcome measure.

ENROLLING_BY_INVITATION
Use of SPY Fluorescent Angiography to Reduce Ureteroenteric Stricture Rate Following Urinary Diversion
Description

Ureteroenteric anastomotic stricture is a well-known complication of urinary diversion which occurs in 4-25% of patients. Recent study has yielded that radiation is a significant risk factor for development of ureteroenteric stricture. The goal of this study is to determine whether intraoperative use of SPY fluorescent angiography during urinary diversion reduces rate of ureteroenteric stricture. This study will include 215 patients who have undergone urinary diversion over the past 5 years as historic controls and compare ureteroenteric stricture rates to a prospective cohort of patients in whom intraoperative SPY fluorescent angiography was used at the time of urinary diversion to assess the anastomotic perfusion. This will include injection of ICG intravenously as well as utilization of the SPY device to assess ureteral perfusion before and after ureteroenteric anastomosis. Based on power analysis, this study will require approximately 50 patients in our prospective group to detect a clinically significant difference of 5% between groups. Data analysis plan includes the use of chi square test for comparison of stricture rates between groups. Clinical outcomes will be followed prospectively, with no amendment to standard follow-up per physician.

WITHDRAWN
Intraoperative Fluorescence Angiography in Debridement of Open Fractures
Description

The proposed research aims to be a pilot feasibility study to evaluate intraoperative fluorescence angiography (IFA) as an aid for acute debridement in orthopaedic trauma.

WITHDRAWN
Photoacoustic Computed Tomography for Pre-Operative Reconstructive Flap Angiography
Description

The purpose of this study is to determine if a new non-invasive imaging technology, called Photoacoustic Computed Tomography (PACT), can be used in the pre-operative setting to better visualize the blood supply of reconstructive flaps used in Plastic Surgery.

COMPLETED
OCT Angiography Software Evaluation Study
Description

Comparisons for vascular structure visualization in the retina and choroid.

COMPLETED
Evaluation of Additional Heidelberg Engineering SPECTRALIS With OCT Angiography Module (OCTA Module) Scan Types
Description

Assessment of image quality and clinical relevance of OCT Angiography at different speed/ART combinations

RECRUITING
Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease
Description

This study will perform a prospective, longitudinal analysis of clinical and imaging findings from normal controls and subjects with retinal vascular disease to better define the diagnostic imaging criteria that signify change in disease stage. This includes disease progression in early stages of disease or disease regression with appropriate standard-of-care treatment.