Ignite Creation Date:
2024-05-06 @ 1:31 PM
Last Modification Date:
2024-10-26 @ 1:15 PM
Study NCT ID:
NCT04043377
Status:
TERMINATED
Last Update Posted:
2022-06-30
First Post:
2019-07-23
Brief Title:
68Ga-DOTATATE PET-CTA Imaging for the Early Detection of Progressing Coronary Atherosclerosis
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
68Ga-DOTATATE PET-CTA Imaging for the Early Detection of Progressing Coronary Atherosclerosis
Status:
TERMINATED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Financial issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
iPROGRESS
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
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 M24follow-up Consultation and low-dose cardiac CT for coronary calcium scoring performed
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 M24follow-up Consultation and low-dose cardiac CT for coronary calcium scoring performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-004793-34 | EUDRACT_NUMBER | None | None |