Heart Analysis in GATED-PET in Patients Having a Gallium-68-DOTATOC PET/CT Exam for Oncology Indication

Not Applicable

Recruiting

• Conditions: Cardiac Inflammation
• Interventions: Other: Cardiac ECG-gated PET imaging will added

• Registration Number: NCT06467968
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

Gallium-68-DOTATOC binds primarily with high affinity to somatostatin subtype 2 (SSTR2) receptors and these somatostatin receptors are also overexpressed on inflammation cells when activated.

The hypothesis is that the GATED mode on a Gallium-68-DOTATOC cardiac recording would be able to highlight abnormalities that could be correlated with the age of the patients and their cardiovascular risk factors.

Detailed Description

People with the selection criteria for the study, coming to the nuclear medicine department in order to benefit from a Gallium-68-DOTATOC PET/CT exam as part of a diagnostic or pre-therapeutic assessment of a neuroendocrine tumor will be offer to participate in the study After sign consent, patients were install in a room to have blood drawn for Troponin Ic, BNP and CRP and after Gallium-68-DOTATOC infusion Gallium-68-DOTATOC PET/CT will be recorded and immediately the cardiac record in Gated mode

Study Timeline

• Study First Submitted: 2022-07-07
• Study Start: 2023-02-02
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-18
• Last Update Submitted: 2024-06-18
• Study First Posted: 2024-06-21
• Last Update Posted: 2024-06-21
• Primary Completion: 2024-11-24
• Study Completion: 2025-08-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

Persons who have received complete information on the organization of the research and who have signed the informed consent and:

• Age ≥ 18 years old.
• Having read and understood the information document.
• Affiliated to a social security scheme.

Person for whom a 68Ga-DOTATOC PET/CT exam is requested as part of the diagnostic or pre-therapeutic assessment of a neuroendocrine tumour.

Exclusion Criteria

Person with

• Hypersensitivity during previous use of 68Ga-DOTATOC
• Impossibility of performing a PET-CT (patient agitated, confused, etc.).
• History of heart disease,
• Severe arrhythmia that does not allow the PET synchronized with the ECG
• Severe renal insufficiency (GFR <30 ml/min/1.73 m2)
• Treated with a somatostatin analogue.
• Cushing's syndrome
• Pregnant woman, likely to be or breastfeeding
• Adult subject to a legal protection measure (guardianship, curators, legal safeguard)
• Person of legal age unable to express their consent
• Person deprived of liberty by a judicial or administrative decision
• Person, subject to psychiatric care under articles L. 3212-1 and L. 3213-1

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients	Cardiac ECG-gated PET imaging will added	Person for whom a 68Ga-DOTATOC PET/CT exam is requested as part of the diagnostic or pre-therapeutic assessment of a neuroendocrine tumor

Primary Outcome Measures

Name	Time	Method
Relationship between the captation of radiotracer and the cardiovascular disease	1 day	Measurement of myocardial activity

Secondary Outcome Measures

Name	Time	Method
Relationship between the captation of radiotracer and the troponin value	1 day	Correlation between the myocardial activity and the troponin value

Trial Locations

Locations (1)

Veronique Roch; 🇫🇷 Vandoeuvre les Nancy cedex, France