11C-acetate/18Fluorodeoxyglucose-FDG PET/CT and Cardiac MRI in Pulmonary Hypertension
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| ClinicalTrials.gov Identifier: NCT01917136 |
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Recruitment Status :
Completed
First Posted : August 6, 2013
Results First Posted : February 5, 2019
Last Update Posted : February 5, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pulmonary Hypertension | Drug: 11C-acetate Drug: [18F]Fluoro-2-deoxy-2-D-glucose Other: Cardiac MRI | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 21 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| 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 |
| Actual Study Start Date : | August 2013 |
| Actual Primary Completion Date : | October 2018 |
| Actual Study Completion Date : | October 2018 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 11c-acetate and 18F-FDG, and cardiac MRI
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.
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Drug: 11C-acetate
For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate Drug: [18F]Fluoro-2-deoxy-2-D-glucose For each PET/CT imaging session subjects will receive a 10 millicurie injection of 18F-FDG
Other Name: 18F-FDG Other: Cardiac MRI Cardiac MRI is performed at 6 months to measure any change in structure and function of the treatment groups. |
- Changes in RV Function [ Time Frame: 6 months ]RV function as measured by cardiac MRI
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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"
Exclusion Criteria:
- 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
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): NCT01917136
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Yuchi Han, MD | University of Pennsylvania |
Documents provided by University of Pennsylvania:
| Responsible Party: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01917136 |
| Obsolete Identifiers: | NCT01953965 |
| Other Study ID Numbers: |
817786 |
| First Posted: | August 6, 2013 Key Record Dates |
| Results First Posted: | February 5, 2019 |
| Last Update Posted: | February 5, 2019 |
| Last Verified: | November 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | Data available upon request |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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pulmonary hypertension right ventricular function 11C acetate FDG ranolazine |
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Hypertension, Pulmonary Hypertension Vascular Diseases Cardiovascular Diseases Lung Diseases |
Respiratory Tract Diseases Fluorodeoxyglucose F18 Radiopharmaceuticals Molecular Mechanisms of Pharmacological Action |