Ga-68 MAA Distribution in PAE Patients

• Status: Withdrawn
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborators: BTG International Inc.; Embolx, Inc.

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)