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

NCT06467968 | Recruiting

• 1 other identifier: 2022PI008
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Inflammation

Outcome Measures

Primary Outcomes (1)

• Relationship between the captation of radiotracer and the cardiovascular disease

  Measurement of myocardial activity

  1 day

Secondary Outcomes (1)

• Relationship between the captation of radiotracer and the troponin value

  1 day

Study Arms (1)

Patients

EXPERIMENTAL

Person for whom a 68Ga-DOTATOC PET/CT exam is requested as part of the diagnostic or pre-therapeutic assessment of a neuroendocrine tumor

Other: Cardiac ECG-gated PET imaging will added

Interventions

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

Also known as: blood sample

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Veronique Roch

Vandœuvre-lès-Nancy, 54511, France

RECRUITING

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mathieu PERRIN, MD

  CHRU Nancy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

VERONIQUE ROCH, MSc

CONTACT

03 83 15 42 76; v.roch@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: June 21, 2024
• Study Start: February 2, 2023
• Primary Completion: November 24, 2024
• Study Completion: August 26, 2025
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

FR (1)