Ga-68 MAA Distribution in PAE Patients

University of North Carolina (UNC)

Status and phase

Withdrawn

Early Phase 1

Conditions

Benign Prostatic Hyperplasia

Treatments

Drug: Gallium 68 Macro-aggregated albumin

Study type

Interventional

Funder types

Other

Identifiers

NCT04243824

19-2669

Details and patient eligibility

About

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.

Full 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.

Sex

Male

Ages

40+ years old

Volunteers

No Healthy Volunteers

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)