Contribution of PET/MRI in Locally Advanced Cervical Cancer (ATICC)

Recruiting

• Conditions: Cervical Cancer

• Registration Number: NCT06083103
• Lead Sponsor: Institut de cancérologie Strasbourg Europe

Brief Summary

\[18 F\]fluorodeoxyglucose (18F-FDG) positron emission tomography-magnetic resonance imaging (PET/MRI) is a new hybrid imaging tool that has recently arrived in oncology, and is particularly promising. Its usefulness seems obvious in certain tumor types, but its place in the staging of cervical cancers has never been explored in a prospective trial to our knowledge.

Previously, a comparative retrospective study from 2009 found a better sensitivity of PET fused to diagnostic MRI images compared to PET/CT (positron emission tomography/computed tomography) in the detection of metastatic lymph nodes (54 and 44% respectively). It was an a posteriori fusion of images, from images acquired by PET-CT.

Detailed Description

This monocentric, prospective trial aims at comparing performances of 18F-FDG PET/MRI versus standard PET/CT in the detection of lymph node metastases in cervical cancer patients. Specificity and sensitivity of both exams will be compared at one timepoint, during the PET/CT prescribed in routine care for assessment of extension. PET/MRI will be conducted directly after PET/CT and a unique dose of 18F-FDG radiotracer will be used for both exams.

Study Timeline

• Study First Submitted: 2023-10-06
• Study Start: 2023-10-12
• Study First Submitted QC: 2023-10-12
• Study First Posted: 2023-10-13
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Patients aged from 18 years old and over
• Patients with presumed cervical cancer of stages IB2 to IVA based on clinical data and pelvic MRI, undergoing pre-treatment assessment.
• For women of childbearing potential : Adequate contraception throughout study participation.

Note : enrollment in a concomitant clinical trial is authorized

Exclusion Criteria

• Oncological history that could possibly interfere with imaging results interpretation, apart from cervical cancer
• Extra-nodal metastasis clinically or radiologically proven before study participation
• Contraindication to MRI or injection of contrast agents containing gadolinium
• Contraindication to lumbo-aortic lymphadenectomy
• Persons deprived of liberty
• Minor or patients placed under guardianship or supervision
• Patient under judicial protection
• Patient unable to consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare performances of PET/MRI and PET/CT in the detection of lumbar aortic lymph node metastases in cervical cancer patients with tumors graded IB2 to IVA stage	Up to 3 months	Performances in terms of sensitivity

Secondary Outcome Measures

Name	Time	Method
Compare performances of PET/MRI and PET/CT in the detection of lymph node metastases in cervical cancer patients with tumors graded IB2 to IVA stage, outside of lumbar aortic region	Up to 3 months	Performances in terms of sensitivity
Compare performances PET/MRI and para-aortic lymphadenectomy in the detection of lumbar aortic lymph node metastases in cervical cancer patients	Up to 3 months	Lumbar/aortic lymph nodes detection with each exams

Trial Locations

Locations (1)

Institut de cancérologie Strasbourg Europe; 🇫🇷 Strasbourg, France