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

NCT ID: NCT03809689

Last Updated: 2024-06-20

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2023-10-11

Brief Summary

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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

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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.

Conditions

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Myocardial Infarction, Acute Myocardial Reperfusion Chronic Ischemic Heart Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

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

Group Type OTHER

68Ga-NODAGA-RGD PET/CT

Intervention Type OTHER

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

Intervention Type DIAGNOSTIC_TEST

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

Group Type OTHER

68Ga-NODAGA-RGD PET/CT

Intervention Type OTHER

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

Intervention Type DIAGNOSTIC_TEST

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

Group Type OTHER

68Ga-NODAGA-RGD PET/CT

Intervention Type OTHER

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type OTHER

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Lausanne Hospitals

OTHER

Sponsor Role lead

Responsible Party

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John O. Prior

PhD, MD, Head of Nuclear Medicine Department

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Switzerland

Other Identifiers

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68Ga-NODAGA-RGD cardiac PET

Identifier Type: -

Identifier Source: org_study_id

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