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

NCT04043377 | Terminated Phase 3

• 2 other identifiers: P 1711032017-004793-34
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Arteriosclerosis

Keywords

Coronary atherosclerosis; 68Ga-DOTATATE; PET-CTA imaging; No significant myocardial ischemia

Outcome Measures

Primary Outcomes (1)

• Absolute increase in calcium artery calcium scoring (CACS) per year.

  The volume of calcium along coronary arteries will be measured on low-dose gated CT acquisitions using a dedicated software. The increase in CACS will be measured as the difference between the CACS measured at baseline and 2 years later and a yearly increase rate of CACS will be calculated.

  2 years

Secondary Outcomes (8)

• Combined end point including cardiovascular death, acute coronary syndrome and ischemia-driven coronary revascularization.

  2 years

• Characterization of coronary plaques 1

  2 years

• Characterization of coronary plaques 2

  2 years

• Characterization of coronary plaques 3

  2 years

• Characterization of coronary plaques 4

  2 years

Study Arms (1)

All patients

EXPERIMENTAL

Drug: injection of 68Ga-DOTATATE

Interventions

injection of 68Ga-DOTATATE 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.

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

service de médecine nucléaire-Hôpital Bichat

Paris, 75018, France

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Fabien HYAFIL, Doctor

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: August 2, 2019
• Study Start: November 21, 2019
• Primary Completion: September 13, 2021
• Study Completion: September 13, 2021
• Last Updated: June 30, 2022

Record last verified: 2022-06

Locations

FR (1)