Heart Analysis in GATED-PET in Patients Having a Gallium-68-DOTATOC PET/CT Exam for Oncology Indication
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cardiac ECG-gated PET imaging will added.
- Who it may be relevant to
- Registry conditions: Cardiac Inflammation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
GATED-PET Heart Analysis in Patients Having a Gallium-68--DOTATOC PET/CT Exam for Oncology Indication
Overview
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
Interventions
- 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
Primary outcome measures
- Relationship between the captation of radiotracer and the cardiovascular disease [Time frame: 1 day]
Secondary outcome measures (1)
- Relationship between the captation of radiotracer and the troponin value [Time frame: 1 day]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Veronique Roch — Vandœuvre-lès-Nancy
Identifiers
NCT: NCT06467968 · 2022PI008