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Ga-68 MAA Distribution in PAE Patients

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ClinicalTrials.gov Identifier: NCT04243824
Recruitment Status : Withdrawn (Lack of funding)
First Posted : January 28, 2020
Last Update Posted : January 15, 2021
Sponsor:
Collaborators:
BTG International Inc.
Embolx, Inc.
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.


Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Drug: Gallium 68 Macro-aggregated albumin Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Evaluation of Ga-68 MAA Distribution in Prostatic Artery Embolization Patients
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: All participants
All enrolled study participants will receive Ga-68MAA and PET/MRI scan.
Drug: Gallium 68 Macro-aggregated albumin
The radiotracer, Ga-68 MAA, will be administered prior to PET/MRI scan.
Other Name: radiotracer




Primary Outcome Measures :
  1. Ga-68 MAA radiotracer activity within adjacent organs [ Time Frame: Upon completion of all study image data collection for all participants [approximately 1 year] ]
    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.


Secondary Outcome Measures :
  1. Ga-68 MAA radiotracer activity within the prostate gland [ Time Frame: Upon completion of all study image data collection for all participants [approximately 1 year after study start] ]
    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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Gender is based on the anatomical gender assigned at birth. Patients must have a prostate in order to enroll in this study.
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243824


Locations
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United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
BTG International Inc.
Embolx, Inc.
Investigators
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Principal Investigator: Jessica Stewart, MD University of North Carolina, Chapel Hill
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT04243824    
Other Study ID Numbers: 19-2669
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Supporting Materials: 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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases