Ga-68 MAA Distribution in PAE Patients
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|ClinicalTrials.gov Identifier: NCT04243824|
Recruitment Status : Withdrawn (Lack of funding)
First Posted : January 28, 2020
Last Update Posted : January 15, 2021
Purpose: The purpose of this study is to evaluate Ga-68 MAA distribution on PET/MRI after injection into the prostatic arteries in patients without prostate cancer who are being treated with prostate artery embolization for benign prostatic hyperplasia.
Participants: Study subjects will be 5 men scheduled to undergo the PAE procedure at UNC Hospital for benign prostatic hyperplasia.
Procedures (methods): Study subjects will undergo PAE using the standard technique. Prior to embolization of the prostatic artery with the bland embolic agent, Ga-68 MAA will be injected. Standard departmental radiation protection procedures will be followed. After the PAE procedure is complete, the patient will be transported to the UNC Biomedical Research Imaging Center to undergo PET/MRI.
|Condition or disease||Intervention/treatment||Phase|
|Benign Prostatic Hyperplasia||Drug: Gallium 68 Macro-aggregated albumin||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Evaluation of Ga-68 MAA Distribution in Prostatic Artery Embolization Patients|
|Estimated Study Start Date :||May 2021|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||May 2022|
Experimental: All participants
All enrolled study participants will receive Ga-68MAA and PET/MRI scan.
Drug: Gallium 68 Macro-aggregated albumin
The radiotracer, Ga-68 MAA, will be administered prior to PET/MRI scan.
Other Name: radiotracer
- Ga-68 MAA radiotracer activity within adjacent organs [ Time Frame: Upon completion of all study image data collection for all participants [approximately 1 year] ]The mean radiotracer levels within adjacent organs in the target population of patients will be estimated in the sample of N=5 patients, along with standard errors, and 95% confidence intervals.
- Ga-68 MAA radiotracer activity within the prostate gland [ Time Frame: Upon completion of all study image data collection for all participants [approximately 1 year after study start] ]The mean radiotracer amounts within the central and peripheral prostate gland in the target population of patients will be estimated in the sample of N=5 patients, along with standard errors, and 95% confidence intervals.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243824
|United States, North Carolina|
|University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Jessica Stewart, MD||University of North Carolina, Chapel Hill|