Contribution of PET/MRI in Locally Advanced Cervical Cancer (ATICC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 18-FDG PET-MRI.
- Who it may be relevant to
- Registry conditions: Cervical Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Contribution of PET/MRI in Locally Advanced Cervical Cancer
Overview
\[18 F\]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.
Interventions
- Diagnostic test 18-FDG PET-MRI
For this trial, 18-FDG PET-MRI will be conducted directly after PET-CT using a single dose of radiotracer
Primary outcome measures
- 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 [Time frame: Up to 3 months]
Secondary outcome measures (2)
- 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 [Time frame: Up to 3 months]
- Compare performances PET/MRI and para-aortic lymphadenectomy in the detection of lumbar aortic lymph node metastases in cervical cancer patients [Time frame: Up to 3 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Institut de cancérologie Strasbourg Europe — Strasbourg
Publications
- Picardi M, Cavaliere C, Della Pepa R, Nicolai E, Soricelli A, Giordano C, Pugliese N, Rascato MG, Cappuccio I, Campagna G, Cerchione C, Vigliar E, Troncone G, Mascolo M, Franzese M, Castaldo R, Salvatore M, Pane F. PET/MRI for staging patients with Hodgkin lymphoma: equivalent results with PET/CT in a prospective trial. Ann Hematol. 2021 Jun;100(6):1525-1535. doi: 10.1007/s00277-021-04537-5. Epub PMID 33909101
- Lu XR, Qu MM, Zhai YN, Feng W, Gao Y, Lei JQ. Diagnostic role of 18F-FDG PET/MRI in the TNM staging of breast cancer: a systematic review and meta-analysis. Ann Palliat Med. 2021 Apr;10(4):4328-4337. doi: 10.21037/apm-20-2555. Epub 2021 Apr 12. PMID 33894709
- Crimi F, Spolverato G, Lacognata C, Garieri M, Cecchin D, Urso ED, Zucchetta P, Pucciarelli S, Pomerri F. 18F-FDG PET/MRI for Rectal Cancer TNM Restaging After Preoperative Chemoradiotherapy: Initial Experience. Dis Colon Rectum. 2020 Mar;63(3):310-318. doi: 10.1097/DCR.0000000000001568. PMID 31842163
- Kim SK, Choi HJ, Park SY, Lee HY, Seo SS, Yoo CW, Jung DC, Kang S, Cho KS. Additional value of MR/PET fusion compared with PET/CT in the detection of lymph node metastases in cervical cancer patients. Eur J Cancer. 2009 Aug;45(12):2103-9. doi: 10.1016/j.ejca.2009.04.006. Epub 2009 May 4. PMID 19403303
Identifiers
NCT: NCT06083103 · 2021-013 · 2023-A00743-42