68Ga-DOTATATE PET-CTA Imaging for the Early Detection of Progressing Coronary Atherosclerosis

NCT ID: NCT04043377

Last Updated: 2022-06-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-21
• Study Completion Date: 2021-09-13

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 SSTR2 receptor is also highly expressed at the surface of human macrophages and lymphocytes. In comparison to FDG, 68Ga-DOTATATE presents the advantage of fast clearance from tissues, which are not expressing somatostatin receptors, in particular muscular and myocardial tissues, and the level of blood glucose does not influence its uptake.

Accumulation of 68Ga-DOTATATE has already been detected in coronary and carotid plaques and is associated with the number of activated macrophages present in plaques obtained after carotid endarterectomy. In a recent study, Tarkin et al. confirmed the preferential uptake of 68Ga-DOTATATE by macrophages in atherosclerotic plaques. In addition, the intensity of 68Ga-DOTATATE was higher in culprit lesions in the carotid and coronary arteries than in stable lesions. The evaluation of 68Ga-DOTATATE uptake in coronary arteries was also strongly facilitated in comparison to FDG thanks to the absence of spillover signal from the myocardium.

AAA has developed a new kit that has markedly simplified the synthesis of 68Ga-DOTATATE and has obtained in the US marketing authorization for the kit (Netspot; kit for the preparation of Gallium-68-DOTATATE injection for intravenous use) on June 1st 2016 (NDA 208547) for evaluation of patients with neuro-endocrine tumors. The Netspot kit will be used in this study for the detection of progressing coronary atherosclerosis.

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 plaques quantified with PET at M0 and the absolute progression rate of coronary artery calcium scoring (CACS) measured between the CT acquired at M0 and after 2 years.

Patients will be screened until 1 month before the inclusion (M0) visit. Thereafter, 3 visits specifics to the study will be performed.

M0 (baseline): Injection of 68Ga-DOTATATE followed by PET-scan and a CCTA-scan M12 et M24(follow-up): Consultation and low-dose cardiac CT for coronary calcium scoring performed

Conditions

Coronary Arteriosclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

All patients

Group Type: EXPERIMENTAL

injection of 68Ga-DOTATATE

Intervention Type: DRUG

PET after injection of 68Ga-DOTATATE 2 MBq/kg (Max. 200 MBq); intra-venous; single injection, at M0 followed by a coronary CTA to localize the signal in coronary arteries Consultation and low-dose cardiac CT for coronary calcium scoring performed at M12 and M24 after inclusion.

Interventions

injection of 68Ga-DOTATATE

PET after injection of 68Ga-DOTATATE 2 MBq/kg (Max. 200 MBq); intra-venous; single injection, at M0 followed by a coronary CTA to localize the signal in coronary arteries Consultation and low-dose cardiac CT for coronary calcium scoring performed at M12 and M24 after inclusion.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabien HYAFIL, Doctor

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

service de médecine nucléaire-Hôpital Bichat

Paris, , France

Countries

France

Other Identifiers

2017-004793-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P 171103

Identifier Type: -

Identifier Source: org_study_id