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Trial Title:
Heart Analysis in GATED-PET in Patients Having a Gallium-68-DOTATOC PET/CT Exam for Oncology Indication
NCT ID:
NCT06467968
Condition:
Cardiac Inflammation
Conditions: Official terms:
Inflammation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Cardiac ECG-gated PET imaging will added
Description:
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
Arm group label:
Patients
Other name:
blood sample
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
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Veronique Roch
Address:
City:
Vandoeuvre les Nancy cedex
Zip:
54511
Country:
France
Status:
Recruiting
Contact:
Last name:
VERONIQUE ROCH
Email:
v.roch@chru-nancy.fr
Start date:
February 2, 2023
Completion date:
August 26, 2025
Lead sponsor:
Agency:
Central Hospital, Nancy, France
Agency class:
Other
Source:
Central Hospital, Nancy, France
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06467968
