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

C

Central Hospital, Nancy, France

Status

Enrolling

Conditions

Cardiac Inflammation

Treatments

Other: Cardiac ECG-gated PET imaging will added

Study type

Interventional

Funder types

Other

Identifiers

NCT06467968
2022PI008

Details and patient eligibility

About

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.

Full 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

Enrollment

99 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

99 participants in 1 patient group

Patients
Experimental group
Description:
Person for whom a 68Ga-DOTATOC PET/CT exam is requested as part of the diagnostic or pre-therapeutic assessment of a neuroendocrine tumor
Treatment:
Other: Cardiac ECG-gated PET imaging will added

Trial contacts and locations

1

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Central trial contact

VERONIQUE ROCH, MSc

Data sourced from clinicaltrials.gov

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