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

Cardiac Inflammation Clinical Trial

— GATEDOTA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06467968
• Other study ID #: 2022PI008
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2023
• Est. completion date: August 26, 2025

Study information

• Verified date: June 2024
• Source: Central Hospital, Nancy, France
• Contact: VERONIQUE ROCH, MSc
• Phone: 03 83 15 42 76
• Email: v.roch[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 99
• Est. completion date: August 26, 2025
• Est. primary completion date: November 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Inflammation
• Inflammation

Intervention

Other:
• Cardiac ECG-gated PET imaging will added
Blood sample will be used to measure troponin, BNP and CRP . After 68Ga-DOTATOC PET/CT whole body recording, a cardiac ECG-gated PET imaging will added

Locations

Country	Name	City	State
France	Veronique Roch	Vandoeuvre les Nancy cedex

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between the captation of radiotracer and the cardiovascular disease	Measurement of myocardial activity	1 day
Secondary	Relationship between the captation of radiotracer and the troponin value	Correlation between the myocardial activity and the troponin value	1 day