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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06467968
Acronym
GATEDOTA
Enrollment
99
Registered
2024-06-21
Start date
2023-02-02
Completion date
2027-05-26
Last updated
2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Inflammation

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

Interventions

OTHERCardiac 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

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Relationship between the captation of radiotracer and the cardiovascular disease1 dayMeasurement of myocardial activity

Secondary

MeasureTime frameDescription
Relationship between the captation of radiotracer and the troponin value1 dayCorrelation between the myocardial activity and the troponin value

Countries

France

Contacts

CONTACTVERONIQUE ROCH, MSc
v.roch@chru-nancy.fr03 83 15 42 76
PRINCIPAL_INVESTIGATORMathieu PERRIN, MD

CHRU Nancy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026