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Ga-68 MAA Distribution in PAE Patients

Primary Purpose

Benign Prostatic Hyperplasia

Status

Withdrawn

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Gallium 68 Macro-aggregated albumin

About this trial

This is an interventional diagnostic trial for Benign Prostatic Hyperplasia

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept 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)

Sites / Locations

University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All participants

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Ga-68 MAA radiotracer activity within the prostate gland

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.

Full Information

NCT ID

NCT04243824

First Posted

January 24, 2020

Last Updated

January 13, 2021

Sponsor

University of North Carolina, Chapel Hill

Collaborators

BTG International Inc., Embolx, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04243824

Brief Title

Ga-68 MAA Distribution in PAE Patients

Official Title

The Evaluation of Ga-68 MAA Distribution in Prostatic Artery Embolization Patients

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Lack of funding

Study Start Date

May 2021 (Anticipated)

Primary Completion Date

May 2022 (Anticipated)

Study Completion Date

May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of North Carolina, Chapel Hill

Collaborators

BTG International Inc., Embolx, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Prostatic Hyperplasia

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

All participants

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Gallium 68 Macro-aggregated albumin

Other Intervention Name(s)

radiotracer

Intervention Description

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

Primary Outcome Measure Information:

Title

Ga-68 MAA radiotracer activity within adjacent organs

Description

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.

Time Frame

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

Secondary Outcome Measure Information:

Title

Ga-68 MAA radiotracer activity within the prostate gland

Description

Time Frame

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

10. Eligibility

Sex

Male

Gender Based

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.

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jessica Stewart, MD

Organizational Affiliation

University of North Carolina, Chapel Hill

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of North Carolina at Chapel Hill

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing Time Frame

9 to 36 months following publication

IPD Sharing 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.

Learn more about this trial

Ga-68 MAA Distribution in PAE Patients

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