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出境医 / 临床实验 / Study of Cardiac Lesions Angiogenesis by 68Ga-NODAGA-RGD Cardiac PET
Study of Cardiac Lesions Angiogenesis by 68Ga-NODAGA-RGD Cardiac PET
Study Description
Brief Summary:
The study is about exploring physiological angiogenesis linked to tissue repair in patients with acute heart infarction or chronic heart ischemia by means of 68Ga-NODAGA-RGD PET/CT imaging.
| 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 |
Detailed Description:
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 Design
| 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 : | February 28, 2021 |
| Estimated Study Completion Date : | February 28, 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
acute infarction
patients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT at 1, 4 and 12 weeks after cardiac event
|
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
|
|
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
|
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
|
|
chronic ischemic occlusion
patients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT before and 2 months after reperfusion treatment
|
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
|
Outcome Measures
Primary Outcome Measures :
- 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
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Contacts
| Contact: John O Prior, PhD, MD | +41 21 314 43 48 | john.prior@chuv.ch |
Locations
| 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 | |
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
| Principal Investigator: | John O Prior, PhD, MD | Lausanne University Hospital |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | December 2, 2018 | ||||
| First Posted Date ICMJE | January 18, 2019 | ||||
| Last Update Posted Date | March 19, 2020 | ||||
| Actual Study Start Date ICMJE | November 1, 2018 | ||||
| Estimated Primary Completion Date | February 28, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of Cardiac Lesions Angiogenesis by 68Ga-NODAGA-RGD Cardiac PET | ||||
| Official Title ICMJE | Study of Acute and Chronic Myocardiac Lesions Angiogenesis by 68Ga-NODAGA-RGD Cardiac PET | ||||
| Brief Summary | The study is about exploring physiological angiogenesis linked to tissue repair in patients with acute heart infarction or chronic heart ischemia by means of 68Ga-NODAGA-RGD PET/CT imaging. | ||||
| Detailed Description |
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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
60 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | February 28, 2021 | ||||
| Estimated Primary Completion Date | February 28, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 85 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Switzerland | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03809689 | ||||
| Other Study ID Numbers ICMJE | 68Ga-NODAGA-RGD cardiac PET | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | John O. Prior, University of Lausanne Hospitals | ||||
| Study Sponsor ICMJE | University of Lausanne Hospitals | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | University of Lausanne Hospitals | ||||
| Verification Date | March 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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