Ga-68 MAA Distribution in PAE Patients

NCT ID: NCT04243824

Last Updated: 2021-01-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-31
• Study Completion Date: 2022-05-31

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.

Conditions

Benign Prostatic Hyperplasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

All participants

All enrolled study participants will receive Ga-68MAA and PET/MRI scan.

Group Type: EXPERIMENTAL

Gallium 68 Macro-aggregated albumin

Intervention Type: DRUG

The radiotracer, Ga-68 MAA, will be administered prior to PET/MRI scan.

Interventions

Gallium 68 Macro-aggregated albumin

The radiotracer, Ga-68 MAA, will be administered prior to PET/MRI scan.

Intervention Type: DRUG

Other Intervention Names

radiotracer

Eligibility Criteria

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)

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

BTG International Inc.

OTHER

Sponsor Role: collaborator

Embolx, Inc.

UNKNOWN

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Stewart, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

19-2669

Identifier Type: -

Identifier Source: org_study_id