Interest of PET/CT at 18F-FDG in the Post-therapeutic Management of Cervical Cancer
NCT ID: NCT04008095
Last Updated: 2023-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
40 participants
OBSERVATIONAL
2020-01-08
2026-01-08
Brief Summary
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Whereas 18F-FDG PET/CT is useful for prognosis in the follow-up, data are yet insufficient to clearly establish a formal recommendation.
This prospective multicenter observational study will evaluate the interest of post therapy 18F-FDG PET/CT in clinical management (within 2 months of treatment) in patients with cervical cancer at an advanced stage.
Main outcome :
The therapeutic impact of post therapy 18F-FDG PET/CT (within 2 months after the end of therapy) will be evaluated on the complete results included MRI.
Investigators will compare :
* decision of clinicians without 18F-FDG PET/CT results
* and decision of clinicians knowing entire results included results of 18F-FDG PET/CT.
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Detailed Description
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Management of uterine cervical cancer is well defined before treatment, especially for imaging including systematically pelvic MRI and 18F-FDG PET/CT.
A lot of studies have demonstrated the prognostic value of post therapy 18F-FDG PET/CT, due to semi quantitative parameters study, like the SUV max and delta SUV between pre and post therapy 18F-FDG PET/CT or qualitatively with the persistence of positive 18F-FDG PET/CT at the end of therapy.
Whereas 18F-FDG PET/CT is useful for prognosis in the follow-up, data are yet insufficient to clearly establish a formal recommendation.
Nevertheless, post therapy 18F-FDG PET/CT is still usually requested by a lot of clinicians.
Furthermore, the group of Parisian public hospital (AP-HP) has established a guide for the management of cervical cancer (2016) and recommends to systematically realize a 18F-FDG PET/CT after treatment for advanced cervical cancer.
Main purpose :
Evaluate the role of post therapy 18F-FDG PET/CT in clinical management (within 2 months of treatment) in patients with uterine cervical cancer at an advanced stage.
Main outcome :
The therapeutic impact of post therapy 18F-FDG PET/CT (within 2 months after the end of therapy) will be evaluated on the complete results included MRI.
Investigators will compare
* decision of clinicians without 18F-FDG PET/CT results
* and decision of clinicians knowing entire results included results of 18F-FDG PET/CT.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Uterine cervical cancer with locally-advanced (FIGO 2019 IB3 to IVA)
* Histology: squamous cell carcinoma and adenocarcinoma
* Feasibility of a curative treatment
* Having formulated a non-opposition
Exclusion Criteria
* Pregnancy or breastfeeding
* Other type of tumor than squamous cell carcinoma and adenocarcinoma
* FIGO 2019 \< IB3 or \> IVA
* Non-eligibility for the examination
* Contraindication to MRI and PET/CT
* Previous history of cancer
* Refusal of participation
18 Years
FEMALE
No
Sponsors
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University Hospital, Brest
OTHER
Responsible Party
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Locations
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CHRU de Brest (Hôpital Morvan)
Brest, , France
Centre Henri Becquerel
Rouen, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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29BRC19.0084
Identifier Type: -
Identifier Source: org_study_id
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