Ga-68 MAA Distribution in PAE Patients

Early Phase 1

Withdrawn

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Drug: Gallium 68 Macro-aggregated albumin

• Registration Number: NCT04243824
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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.

Detailed Description

This study is an initial proof of concept evaluation to determine the feasibility of using Y-90 radioembolization performed using the Sniper balloon occlusion microcatheter to treat localized prostate cancer. This will be performed by evaluating 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. The distribution of the radiotracer activity within the prostate and any activity in adjacent organs will be determined for when the tracer is injected into the central prostatic arteries.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-01-24
• Study First Submitted QC: 2020-01-24
• Study First Posted: 2020-01-28
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-13
• Last Update Posted: 2021-01-15
• Study Start: 2021-05
• Primary Completion: 2022-05
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

• Male
• Age > 40
• Prostate gland >50 grams as measured by pre-procedural CTA
• Have previously taken BPH medication for 6 months without desired improvement of LUTS or has started medication and stopped due to unwanted side effects
• Moderate to severe LUTS as defined by IPSS score >18
• Peak urine flow rate (Qmax) <12 mL/sec
• Capable of giving informed consent
• Life expectancy greater than 1 year

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Exclusion Criteria

• Severe vascular disease
• Uncontrolled diabetes mellitus
• Immunosuppression
• Unable to lie flat, still or tolerate a PET/MRI scan.
• Neurogenic bladder and/or sphincter abnormalities secondary to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc.
• Complete urinary retention
• Impaired kidney function (serum creatinine level > 1.8 mg/dl or a glomerular filtration rate < 60 as approximated using serum creatinine levels) unless anuric and on dialysis.
• Confirmed or suspected bladder cancer
• Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology
• Ongoing urogenital infection
• Previous pelvic radiation or radical pelvic surgery
• Confirmed or suspected malignancy of the prostate based on DRE, TRUS or PSA (> 10 ng/mL or > 4.0 ng/mL and < 10 ng/mL with free PSA < 25% of total PSA without a negative biopsy).
• Uncorrectable coagulopathy including INR > 1.5 or platelets < 50,000
• Contrast hypersensitivity refractory to standard medications (antihistamines, steroids)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All participants	Gallium 68 Macro-aggregated albumin	All enrolled study participants will receive Ga-68MAA and PET/MRI scan.

Primary Outcome Measures

Name	Time	Method
Ga-68 MAA radiotracer activity within adjacent organs	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.

Secondary Outcome Measures

Name	Time	Method
Ga-68 MAA radiotracer activity within the prostate gland	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.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States