Ga-68 MAA Distribution in PAE Patients

NCT04243824 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: 19-2669
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Ga-68 MAA radiotracer activity within the prostate gland

  Upon completion of all study image data collection for all participants [approximately 1 year after study start]

Study Arms (1)

All participants

EXPERIMENTAL

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

Drug: Gallium 68 Macro-aggregated albumin

Interventions

Gallium 68 Macro-aggregated albumin DRUG

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

Also known as: radiotracer

All participants

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Gender is based on the anatomical gender assigned at birth. Patients must have a prostate in order to enroll in this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• BTG International Inc.: collaborator
• Embolx, Inc.: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Jessica Stewart, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: January 28, 2020
• Study Start: May 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 9 to 36 months following publication
• Access Criteria: The investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.

Locations

US (1)