Study of Cardiac Lesions Angiogenesis by 68Ga-NODAGA-RGD Cardiac PET
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| ClinicalTrials.gov Identifier: NCT03809689 |
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Recruitment Status :
Recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Myocardial Infarction, Acute Myocardial Reperfusion Chronic Ischemic Heart Disease | Other: 68Ga-NODAGA-RGD PET/CT Diagnostic Test: 82-Rb PET/CT as part of standard care, not a comparator | Not Applicable |
Several animal studies have demonstrated the expression of αvβ3 integrins on the surface of the endothelium present in neovessels in formation, especially during neoangiogenesis after myocardial ischemic injury.
68Ga-NODAGA-RGD is a positron-emission-tomography (PET) ligand targeted towards αvβ3 integrins. αvβ3 integrins could potentially act as a biomarker for the follow-up of heart infarction.
In the present study, 68Ga-NODAGA-RGD PET/CT imaging is a tool to understand and evaluate tissue repair after heart lesion and its evolution allowing a better management of patients with occluded artery.
Three groups of patients are included : patients with acute infarction, patients with acute infarction requiring reperfusion treatment and patients with chronic ischemic occlusion.
Each patient would benefit from a 82Rb (82rubidium) PET/CT as part of standard management and from a 68Ga-NODAGA-RGD PET/CT as part of the present study.
Patients from groups 1 and 2 will have 3 sets of both exams : one after the ischemic event, one at one month and another at 3 months post event.
Patients form group 3 will have a set of both exams before reperfusion treatment and one at 2 months after reperfusion.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Study of Acute and Chronic Myocardiac Lesions Angiogenesis by 68Ga-NODAGA-RGD Cardiac PET |
| Actual Study Start Date : | November 1, 2018 |
| Estimated Primary Completion Date : | November 30, 2020 |
| Estimated Study Completion Date : | April 30, 2021 |
| Arm | Intervention/treatment |
|---|---|
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acute infarction
patients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT at 1, 4 and 12 weeks after cardiac event
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Other: 68Ga-NODAGA-RGD PET/CT
intravenous injection of 200 Megabecquerel (MBq) 68Ga-NODAGA-RGD followed by a whole-body acquisition after injection and one hour after injection Diagnostic Test: 82-Rb PET/CT as part of standard care, not a comparator 2 intravenous injections of standard dose of 82-Rb : the first followed by an at-rest acquisition, the second followed by a pharmacological myocardial stress acquisition |
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acute infarction requiring reperfusion
patients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT at 1, 4 and 12 weeks after cardiac event
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Other: 68Ga-NODAGA-RGD PET/CT
intravenous injection of 200 Megabecquerel (MBq) 68Ga-NODAGA-RGD followed by a whole-body acquisition after injection and one hour after injection Diagnostic Test: 82-Rb PET/CT as part of standard care, not a comparator 2 intravenous injections of standard dose of 82-Rb : the first followed by an at-rest acquisition, the second followed by a pharmacological myocardial stress acquisition |
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chronic ischemic occlusion
patients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT before and 2 months after reperfusion treatment
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Other: 68Ga-NODAGA-RGD PET/CT
intravenous injection of 200 Megabecquerel (MBq) 68Ga-NODAGA-RGD followed by a whole-body acquisition after injection and one hour after injection Diagnostic Test: 82-Rb PET/CT as part of standard care, not a comparator 2 intravenous injections of standard dose of 82-Rb : the first followed by an at-rest acquisition, the second followed by a pharmacological myocardial stress acquisition |
- 82Rb PET/CT : assessment of change of myocardial blood flow at rest and at stress [ Time Frame: at 1, 4 and 12 weeks post ischemic events for patients of groups 1 and 2 - Before and 2 months after reperfusion treatment for patients of group 3 ]mL/min/g
- 82Rb PET/CT : assessment of change of myocardial blood flow reserve at rest and at stress [ Time Frame: at 1, 4 and 12 weeks post ischemic events for patients of groups 1 and 2 - Before and 2 months after reperfusion treatment for patients of group 3 ]mL/min/g
- 82Rb PET/CT : assessment of change of difference of myocardial blood flow at stress and at rest [ Time Frame: at 1, 4 and 12 weeks post ischemic events for patients of groups 1 and 2 - Before and 2 months after reperfusion treatment for patients of group 3 ]mL/min/g
- 68Ga-NODAGA PET/CT : assessment of change of standard uptake value (SUV) [ Time Frame: at 1, 4 and 12 weeks post ischemic events for patients of groups 1 and 2 - Before and 2 months after reperfusion treatment for patients of group 3 ]g/ml
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| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- patients with acute infarction or patients with acute infarction requiring reperfusion treatment or patients with chronic ischemic occlusion
- Karnofsky ≥ 80%
- signed informed consent
Exclusion Criteria:
- pregnancy, breastfeeding
- claustrophobia
- contra-indication to adenosine administration
- lack of discernment to sign informed consent
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): NCT03809689
| Contact: John O Prior, PhD, MD | +41 21 314 43 48 | john.prior@chuv.ch |
| Switzerland | |
| Centre Hospitalier Universitaire Vaudois | Recruiting |
| Lausanne, Vaud, Switzerland, 1011 | |
| Contact: John O. Prior, MD, PhD +41 (0)21-3144348 john.prior@chuv.ch | |
| Principal Investigator: John O. Prior, MD, PhD | |
| Principal Investigator: | John O Prior, PhD, MD | Lausanne University Hospital |
| Responsible Party: | John O. Prior, PhD, MD, Head of Nuclear Medicine Department, University of Lausanne Hospitals |
| ClinicalTrials.gov Identifier: | NCT03809689 History of Changes |
| Other Study ID Numbers: |
68Ga-NODAGA-RGD cardiac PET |
| First Posted: | January 18, 2019 Key Record Dates |
| Last Update Posted: | January 18, 2019 |
| Last Verified: | January 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by John O. Prior, University of Lausanne Hospitals:
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Acute myocardial infarction Myocardial reperfusion treatment Chronic ischemic occlusion 68Ga-NODAGA-RGD |
Additional relevant MeSH terms:
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Infarction Heart Diseases Myocardial Infarction Myocardial Ischemia Coronary Artery Disease Ischemia Pathologic Processes |
Necrosis Cardiovascular Diseases Vascular Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases |