Pulmonary HypertensionPhase 2NCT01917136
11C-acetate/18Fluorodeoxyglucose-FDG PET/CT and Cardiac MRI in Pulmonary Hypertension
A Phase 2 study testing 11C-acetate, [18F]Fluoro-2-deoxy-2-D-glucose and Cardiac MRI in people with Pulmonary Hypertension, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study is looking at differences in metabolism and functional imaging between pulmonary hypertension subjects with normal right ventricular function and persistent right ventricular dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- 11C-acetate, [18F]Fluoro-2-deoxy-2-D-glucose and Cardiac MRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Oct 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participation in the companion treatment protocol "A randomized, double-blind, placebo controlled, multi-center study to assess the effect of ranolazine on outcomes in subjects with pulmonary hypertension and right ventricular dysfunction accompanied by a comparative study of cellular metabolism in subjects with pulmonary hypertension with and without right ventricular dysfunction"
Who cannot join
- Pregnancy or lactation: Women of childbearing potential must have a negative urine or blood pregnancy test on the day of the PET/CT scan.
- Severe anxiety or claustrophobia prohibiting completion of imaging
- Inability to tolerate imaging procedures (1 hour MRI, 30 min and 15 min PET)
- Implantable cardioverter-defibrillator, Pacemaker, hazardous metallic implants or any other contraindication to MRI.
- Uncontrolled diabetes mellitus with fasting glucose > 150 mg/dL
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Evaluation of Regional Myocardial Perfusion, Glucose Utilization and Oxidative Metabolism in Patients With Pulmonary Hypertension Using Combined [11C]Acetate and [18F]Fluorodeoxyglucose (FDG) PET/CT and Cardiovascular MRI
This study is looking at differences in metabolism and functional imaging between pulmonary hypertension subjects with normal right ventricular function and persistent right ventricular dysfunction.
Read the detailed description
We will measure right ventricular metabolic and structural changes using serial 11C-acetate and 18F-FDG PET/CT and cardiac MRI as response to treatment with ranolazine. Subjects undergo imaging procedures at week 0 and week 26 (optional for normal function patients). This is a companion imaging trial for patients who are eligible for the treatment trial entitled "A randomized, double-blind, placebo controlled, multi-center study to assess the effect of ranolazine on outcomes in subjects with pulmonary hypertension and right ventricular dysfunction accompanied by a comparative study of cellular metabolism in subjects with pulmonary hypertension with and without right ventricular dysfunction". Subjects must enroll in companion treatment protocol to qualify for the imaging protocol.
The cardiac MRI portion of the study continued, but the PET portion of the study was discontinued due to funding.
The treatment protocol is registered under: NCT01839110. Due to funding issues, the completed study was registered under NCT02829034.
- Conditions
- Pulmonary Hypertension
- Being tested
- 11C-acetate, [18F]Fluoro-2-deoxy-2-D-glucose, Cardiac MRI
- Keywords
- pulmonary hypertension, right ventricular function, 11C acetate, FDG, ranolazine
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11C-acetateDrug
For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate
[18F]Fluoro-2-deoxy-2-D-glucoseDrug
Also called 18F-FDG
For each PET/CT imaging session subjects will receive a 10 millicurie injection of 18F-FDG
Cardiac MRIOther
Cardiac MRI is performed at 6 months to measure any change in structure and function of the treatment groups.
| Study group | Role | What they receive |
|---|---|---|
| 11c-acetate and 18F-FDG, and cardiac MRI | Experimental | For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate and a 10 millicurie injection of 18F-FDG At baseline/6 months follow up, a cardiac MRI will be performed. Receives: Drug: 11C-acetate; Drug: [18F]Fluoro-2-deoxy-2-D-glucose; Other: Cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in RV Function
RV function as measured by cardiac MRI
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, University of Maryland, Yale University, Washington University School of Medicine, The Cardiovascular Medical Research and Education Fund
- Responsible party
- Sponsor
- Investigators
- Yuchi Han, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917136
- Sponsor's protocol ID
- 817786
- Status last verified
- Nov 2018
- First submitted
- 3 Aug 2013
- Last updated
- 5 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data available upon request
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Regional Myocardial Perfusion, Glucose Utilization and Oxidative Metabolism in Patients With Pulmonary Hypertension Using Combined [11C]Acetate and [18F]Fluorodeoxyglucose (FDG) PET/CT and Cardiovascular MRI
- ClinicalTrials.gov ID
- NCT01917136
- Acronym / sponsor ID
- 817786
- Conditions
- Pulmonary Hypertension
- Keywords
- pulmonary hypertension, right ventricular function, 11C acetate, FDG, ranolazine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, University of Maryland, Yale University, Washington University School of Medicine, The Cardiovascular Medical Research and Education Fund
- Study start
- Aug 2013 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 6 Aug 2013 (estimated)
- Results
- Posted 5 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is looking at differences in metabolism and functional imaging between pulmonary hypertension subjects with normal right ventricular function and persistent right ventricular dysfunction.
Detailed description
We will measure right ventricular metabolic and structural changes using serial 11C-acetate and 18F-FDG PET/CT and cardiac MRI as response to treatment with ranolazine. Subjects undergo imaging procedures at week 0 and week 26 (optional for normal function patients). This is a companion imaging trial for patients who are eligible for the treatment trial entitled "A randomized, double-blind, placebo controlled, multi-center study to assess the effect of ranolazine on outcomes in subjects with pulmonary hypertension and right ventricular dysfunction accompanied by a comparative study of cellular metabolism in subjects with pulmonary hypertension with and without right ventricular dysfunction". Subjects must enroll in companion treatment protocol to qualify for the imaging protocol.
The cardiac MRI portion of the study continued, but the PET portion of the study was discontinued due to funding.
The treatment protocol is registered under: NCT01839110. Due to funding issues, the completed study was registered under NCT02829034.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 11c-acetate and 18F-FDG, and cardiac MRI | Experimental | Drug: 11C-acetate, Drug: [18F]Fluoro-2-deoxy-2-D-glucose, Other: Cardiac MRIFor each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate and a 10 millicurie injection of 18F-FDG At baseline/6 months follow up, a cardiac MRI will be performed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participation in the companion treatment protocol "A randomized, double-blind, placebo controlled, multi-center study to assess the effect of ranolazine on outcomes in subjects with pulmonary hypertension and right ventricular dysfunction accompanied by a comparative study of cellular metabolism in subjects with pulmonary hypertension with and without right ventricular dysfunction"
Key exclusion criteria (5 listed)
- Pregnancy or lactation: Women of childbearing potential must have a negative urine or blood pregnancy test on the day of the PET/CT scan.
- Severe anxiety or claustrophobia prohibiting completion of imaging
- Inability to tolerate imaging procedures (1 hour MRI, 30 min and 15 min PET)
- Implantable cardioverter-defibrillator, Pacemaker, hazardous metallic implants or any other contraindication to MRI.
- Uncontrolled diabetes mellitus with fasting glucose > 150 mg/dL
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 |
|---|---|---|
| 11C-acetateFor each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate | Drug | 11c-acetate and 18F-FDG, and cardiac MRI |
| [18F]Fluoro-2-deoxy-2-D-glucoseAlso: 18F-FDGFor each PET/CT imaging session subjects will receive a 10 millicurie injection of 18F-FDG | Drug | 11c-acetate and 18F-FDG, and cardiac MRI |
| Cardiac MRICardiac MRI is performed at 6 months to measure any change in structure and function of the treatment groups. | Other | 11c-acetate and 18F-FDG, and cardiac MRI |
Primary outcome
Changes in RV Function
Time frame: 6 months
RV function as measured by cardiac MRI
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Data available upon request
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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.
Yuchi Han, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 11C-acetate, [18F]Fluoro-2-deoxy-2-D-glucose and Cardiac MRI in people with Pulmonary Hypertension, run by University of Pennsylvania 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 5 Feb 2019. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in RV Function (time frame: 6 months). 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 5 Feb 2019.