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NCT Number: NCT06467968

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Veronique Roch

Vandœuvre-lès-Nancy, 54511, France

Location status: Recruiting

Location contact

VERONIQUE ROCH

CONTACT

[email protected]

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac ECG-gated PET imaging will added

Other

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

Other names: blood sample

Primary outcomes

  1. Relationship between the captation of radiotracer and the cardiovascular disease

    Time frame: 1 day

    Measurement of myocardial activity

Secondary outcomes

  1. Relationship between the captation of radiotracer and the troponin value

    Time frame: 1 day

    Correlation between the myocardial activity and the troponin value

Study contacts

Contact information is provided by the study sponsor or research team.

VERONIQUE ROCH, MSc

CONTACT

[email protected]

03 83 15 42 76 ext. +33

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: GATEDOTA

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 21, 2024
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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