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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06467968
Other study ID # 2022PI008
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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