Ga-68 MAA Distribution in PAE Patients

Benign Prostatic Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04243824
• Other study ID #: 19-2669
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: May 2021
• Est. completion date: May 2022

Study information

• Verified date: January 2021
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Gallium 68 Macro-aggregated albumin
The radiotracer, Ga-68 MAA, will be administered prior to PET/MRI scan.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	BTG International Inc., Embolx, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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]