Contribution of PET/MRI in Locally Advanced Cervical Cancer (ATICC)
ATICC
2 other identifiers
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2023
CompletedStudy Start
First participant enrolled
October 12, 2023
CompletedFirst Posted
Study publicly available on registry
October 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 11, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 11, 2026
February 2, 2026
January 1, 2026
2.9 years
October 6, 2023
January 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Performances in terms of sensitivity
Up to 3 months
Secondary Outcomes (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
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
Up to 3 months
Interventions
For this trial, 18-FDG PET-MRI will be conducted directly after PET-CT using a single dose of radiotracer
Eligibility Criteria
Patients with presumed cervical cancer of stages IB2 to IVA based on clinical data and pelvic MRI, undergoing pre-treatment assessment.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut de cancérologie Strasbourg Europe
Strasbourg, 67033, France
Related Publications (4)
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 2021 Apr 28.
PMID: 33909101BACKGROUNDLu 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: 33894709BACKGROUNDCrimi 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: 31842163BACKGROUNDKim 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: 19403303BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Éric OUVRARD, MD
Institut de cancérologie Strasbourg Europe
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2023
First Posted
October 13, 2023
Study Start
October 12, 2023
Primary Completion (Estimated)
September 11, 2026
Study Completion (Estimated)
September 11, 2026
Last Updated
February 2, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share