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Study of Cardiac Lesions Angiogenesis by 68Ga-NODAGA-RGD Cardiac PET

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ClinicalTrials.gov Identifier: NCT03809689
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
John O. Prior, University of Lausanne Hospitals

Study Description
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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
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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
Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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
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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
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
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Information from the National Library of Medicine

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


Contacts
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Contact: John O Prior, PhD, MD +41 21 314 43 48 john.prior@chuv.ch

Locations
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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
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Principal Investigator: John O Prior, PhD, MD Lausanne University Hospital
More Information
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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

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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:
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