Clinical trial NCT04243824: Ga-68 MAA Distribution in PAE Patients
Official title: The Evaluation of Ga-68 MAA Distribution in Prostatic Artery Embolization Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: BTG International Inc.
name: Embolx, Inc.
First posted: 2020-01-28
Enrollment: 0
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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)

Primary outcomes:
measure: Ga-68 MAA radiotracer activity within adjacent organs
timeFrame: Upon completion of all study image data collection for all participants [approximately 1 year]
Secondary outcomes:
measure: Ga-68 MAA radiotracer activity within the prostate gland
timeFrame: Upon completion of all study image data collection for all participants [approximately 1 year after study start]
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Jessica Stewart, MD
role: PRINCIPAL_INVESTIGATOR
References: