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

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

NCT ID: NCT06083103

Condition: Cervical Cancer

Conditions: Official terms:
Uterine Cervical Neoplasms
Fluorodeoxyglucose F18

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: 18-FDG PET-MRI
Description: For this trial, 18-FDG PET-MRI will be conducted directly after PET-CT using a single dose of radiotracer

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.

Criteria for eligibility:

Study pop:
Patients with presumed cervical cancer of stages IB2 to IVA based on clinical data and pelvic MRI, undergoing pre-treatment assessment.

Sampling method: Probability Sample
Criteria:
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

Gender: Female

Gender based: Yes

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Institut de cancérologie Strasbourg Europe

Address:
City: Strasbourg
Zip: 67033
Country: France

Status: Recruiting

Contact:
Last name: Éric OUVRARD, MD

Start date: October 12, 2023

Completion date: December 31, 2025

Lead sponsor:
Agency: Institut de cancérologie Strasbourg Europe
Agency class: Other

Source: Institut de cancérologie Strasbourg Europe

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06083103