Benign Prostatic HyperplasiaEarly Phase 1NCT04243824
Ga-68 MAA Distribution in PAE Patients
A Early Phase 1 study testing Gallium 68 Macro-aggregated albumin in people with Benign Prostatic Hyperplasia, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Gallium 68 Macro-aggregated albumin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2021to May 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: The Evaluation of Ga-68 MAA Distribution in Prostatic Artery Embolization Patients
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.
Read the 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.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Gallium 68 Macro-aggregated albumin
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gallium 68 Macro-aggregated albuminDrug
Also called radiotracer
The radiotracer, Ga-68 MAA, will be administered prior to PET/MRI scan.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | All enrolled study participants will receive Ga-68MAA and PET/MRI scan. Receives: Drug: Gallium 68 Macro-aggregated albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Upon completion of all study image data collection for all participants [approximately 1 year after study start]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study startMay 2021 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- BTG International Inc., Embolx, Inc.
- Responsible party
- Sponsor
- Investigators
- Jessica Stewart, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243824
- Sponsor's protocol ID
- 19-2669
- Status last verified
- Jan 2021
- First submitted
- 24 Jan 2020
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Ga-68 MAA Distribution in Prostatic Artery Embolization Patients
- ClinicalTrials.gov ID
- NCT04243824
- Acronym / sponsor ID
- 19-2669
- Conditions
- Benign Prostatic Hyperplasia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- BTG International Inc., Embolx, Inc.
- Study start
- May 2021 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 28 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Drug: Gallium 68 Macro-aggregated albuminAll enrolled study participants will receive Ga-68MAA and PET/MRI scan. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gallium 68 Macro-aggregated albuminAlso: radiotracerThe radiotracer, Ga-68 MAA, will be administered prior to PET/MRI scan. | Drug | All participants |
Primary outcome
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.
1 secondary outcome
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]
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Stewart, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Gallium 68 Macro-aggregated albumin in people with Benign Prostatic Hyperplasia, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ga-68 MAA radiotracer activity within adjacent organs (time frame: Upon completion of all study image data collection for all participants [approximately 1 year]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021; AzTrials last refreshed its copy on 1 Nov 2026.