Interest of PET/CT at 18F-FDG in the Post-therapeutic Management of Cervical Cancer (COLTEP)

  • STATUS
    Recruiting
  • End date
    Jan 8, 2025
  • participants needed
    40
  • sponsor
    University Hospital, Brest
Updated on 24 March 2022
cancer
carcinoma
squamous cell carcinoma
adenocarcinoma
pet/ct scan
fludeoxyglucose f 18

Summary

A lot of studies have demonstrated the prognostic value of post therapy 18F-FDG PET/CT in the management of uterine cervical cancer. Post therapy 18F-FDG PET/CT is usually requested by a lot of clinicians.

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.

Description

With approximately 3000 new cases estimated in France on 2017, the uterine cervical cancer is the twelfth cancer cause in women, responsible for 1000 deaths per year.

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.

Details
Condition Cervical Cancer
Clinical Study IdentifierNCT04008095
SponsorUniversity Hospital, Brest
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient old ≥ 18 years
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

Minor patient < 18 years
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
Clear my responses

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