Study of Cardiac Lesions Angiogenesis by 68Ga-NODAGA-RGD Cardiac PET
NCT ID: NCT03809689
Last Updated: 2024-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
24 participants
INTERVENTIONAL
2018-11-01
2023-10-11
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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
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
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
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
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
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
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* Karnofsky ≥ 80%
* signed informed consent
Exclusion Criteria
* claustrophobia
* contra-indication to adenosine administration
* lack of discernment to sign informed consent
18 Years
85 Years
ALL
No
Sponsors
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University of Lausanne Hospitals
OTHER
Responsible Party
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John O. Prior
PhD, MD, Head of Nuclear Medicine Department
Principal Investigators
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John O Prior, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
University of Lausanne Hospitals
Locations
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Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, Switzerland
Countries
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Other Identifiers
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68Ga-NODAGA-RGD cardiac PET
Identifier Type: -
Identifier Source: org_study_id
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