ACTIVE_NOT_RECRUITING

Augmented Whole-body Scanning Via Magnifying PET/CT (AWSM-PET/CT) Techniques Abilities to Improve Upon the Diagnostic Accuracy of the Standard-of-care (SOC) PET/CT for Malignant Lesion Detection

Conditions

Cancer Magnifying PET virtual-pinhole PET FDG PET/CT

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Fluorodeoxyglucose (FDG)-positron emission tomography (PET)/computed tomography (CT) has been demonstrated to outperform other imaging modalities such as CT and magnetic resonance imaging (MRI) for the detection of metastatic cancers. Therefore, it is currently used for cancer staging, re-staging, and for monitoring response to therapy for many types of cancers. Major advances in PET imaging came to the field in 2016, 2020, 2021 and 2023 when the FDA approved additional PET imaging agents to expand the role of cancer detection to include prostate and neuroendocrine cancers. Despite its wide use and success, the diagnostic accuracy of PET/CT is suboptimal for lesions that are significantly smaller than 1 cm due primarily to limitations on image resolution and system sensitivity. The investigators have developed an Augmented Whole-body Scanning via Magnifying PET (AWSM-PET) technology that can improve the image resolution and system sensitivity of current and future PET/CT scanners. This study will evaluate preliminarily whether the AWSM-PET/CT technology can provide additional high-resolution PET/CT images displayed concurrently with the standard of care PET/CT images to improve overall accuracy in depicting malignant lesions in cancer patients.

Official Title

A Prospective Study of the Augmented Whole-body Scanning Via Magnifying PET/CT (AWSM-PET/CT) Techniques Abilities to Improve Upon the Diagnostic Accuracy of the Standard-of-care (SOC) PET/CT for Malignant Lesion Detection

Quick Facts

Study Start:2024-03-06

Study Completion:2027-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05513027

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Adult patient 18 years of age or older * Patient with suspected or pathologically confirmed diagnosis of carcinoma scheduled to undergo standard of care (SOC) PET/CT for initial diagnosis, initial staging, or suspected recurrence. Preference is to enroll those subjects who will undergo biopsy or surgical resection prior to other cancer treatment. * Willing to undergo PET/CT imaging with AWSM-PET. * Patients of child-bearing potential must have a negative urine pregnancy test on the day of the PET/CT scan. Postmenopausal women who self-report as amenorrheic for at least 12 consecutive months are to be considered not of child-bearing potential. * Patients must be able to understand and sign an IRB-approved informed consent form that allows access to prior medical records, participation in the study and chart review follow up. * Patients are able to tolerate up to approximately 30 min of PET imaging.	* For FDG PET/CT only: Patients who have poorly controlled diabetes (fasting blood glucose \> 200 mg/dL obtained directly prior to FDG administration for PET/CT scan) * Patients whose weight or whose body habitus prohibits the AWSM-PET insert device from being placed at the end of the imaging field of view

Inclusion Criteria

Exclusion Criteria

* Adult patient 18 years of age or older
* Patient with suspected or pathologically confirmed diagnosis of carcinoma scheduled to undergo standard of care (SOC) PET/CT for initial diagnosis, initial staging, or suspected recurrence. Preference is to enroll those subjects who will undergo biopsy or surgical resection prior to other cancer treatment.
* Willing to undergo PET/CT imaging with AWSM-PET.
* Patients of child-bearing potential must have a negative urine pregnancy test on the day of the PET/CT scan. Postmenopausal women who self-report as amenorrheic for at least 12 consecutive months are to be considered not of child-bearing potential.
* Patients must be able to understand and sign an IRB-approved informed consent form that allows access to prior medical records, participation in the study and chart review follow up.
* Patients are able to tolerate up to approximately 30 min of PET imaging.

* For FDG PET/CT only: Patients who have poorly controlled diabetes (fasting blood glucose \> 200 mg/dL obtained directly prior to FDG administration for PET/CT scan)
* Patients whose weight or whose body habitus prohibits the AWSM-PET insert device from being placed at the end of the imaging field of view

Contacts and Locations

Principal Investigator

Yuan-Chuan Tai, Ph.D.

PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Study Locations (Sites)

Washington University School of Medicine

St Louis, Missouri, 63110

United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

Yuan-Chuan Tai, Ph.D., PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-06

Study Completion Date2027-05-31

Study Record Updates

Study Start Date2024-03-06

Study Completion Date2027-05-31

Terms related to this study

Keywords Provided by Researchers

Magnifying PET
virtual-pinhole PET
cancer
FDG PET/CT

Additional Relevant MeSH Terms

Cancer