Ga-68 MAA Distribution in PAE Patients

The Evaluation of Ga-68 MAA Distribution in Prostatic Artery Embolization Patients

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.

Study Overview

• Status: Withdrawn
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Drug: Gallium 68 Macro-aggregated albumin

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.

• Study Type: Interventional
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: radiotracer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ga-68 MAA radiotracer activity within adjacent organs	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.	Upon completion of all study image data collection for all participants [approximately 1 year]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ga-68 MAA radiotracer activity within the prostate gland	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.	Upon completion of all study image data collection for all participants [approximately 1 year after study start]

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: BTG International Inc.; Embolx, Inc.
• Investigators: Principal Investigator: Jessica Stewart, MD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: January 24, 2020
• First Submitted That Met QC Criteria: January 24, 2020
• First Posted (Actual): January 28, 2020

Study Record Updates

• Last Update Posted (Actual): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: 19-2669

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: 9 to 36 months following publication
• IPD Sharing Access Criteria: The investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No