Status:
TERMINATED
68Ga-DOTATATE PET-CTA Imaging for the Early Detection of Progressing Coronary Atherosclerosis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Coronary Arteriosclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
68Ga-DOTATATE is a PET radiotracer with high affinity and selectivity for somatostatin receptor 2 (SSTR 2) and is approved clinically for the evaluation of patients with neuroendocrine tumors. The SST...
Detailed Description
Design of the trial : iPROGRESS is a prospective interventional study. The primary objective of this study will be to test the association between the intensity of 68Ga-DOTATATE uptake in coronary pl...
Eligibility Criteria
Inclusion
- Patients with a coronary artery calcium score (CACS) measured with a low-dose CT between 100 and 1000 and absence of significant ischemia (≥ 12 % of the myocardium) on myocardial perfusion scintigraphy.
- Age ≥ 18 years
- Affiliation to a social security regime
- Signed informed consent.
Exclusion
- Exclusion Criteria :
- Previous acute coronary syndrome or coronary revascularisation
- LVEF \< 40 %
- Previous severe adverse reaction to iodinated contrast agent
- Irregular heart rhythm (chronic atrial fibrillation, numerous extrasystoles)
- Severe asthma
- Chronic kidney disease (eGFR \< 45 ml/min/1.73 m2)
- Waldenstrom disease
- Multiple myeloma
- Autoimmune / inflammatory disease requiring immunosuppressive treatment.
- Active cancer.
- Confirmed or suspected pregnancy
- Breast feeding
- Impossibility to stay immobile and maintain the supine position during 30 minutes.
- Patient deprived of liberty or under legal protection measure
- Participation to an interventional trial involving the use of radiation during the two years of the study.
- Participation to an interventional trial with the use of new drugs between the inclusion and one month after injecting 68Ga-DOTATATE.
Key Trial Info
Start Date :
November 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04043377
Start Date
November 21 2019
End Date
September 13 2021
Last Update
June 30 2022
Active Locations (1)
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1
service de médecine nucléaire-Hôpital Bichat
Paris, France, 75018