Clinical trial NCT04008095: Interest of PET/CT at 18F-FDG in the Post-therapeutic Management of Cervical Cancer
Official title: Evaluation of the Interest of PET/CT at 18F-FDG in the Post-therapeutic Management of Cervical Cancer at an Advanced Stage. Multicenter Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Cancer
Keywords: cervical cancer
pet/ct
post-therapeutic
advanced stage
management
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women recently diagnosed for an advanced cervical cancer (FIGO 2019 IB3 to IVA), and histologically proved.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Validated by six months follow up
measure: collection of the two décisions of RCP
timeFrame: Validated by six months follow up
Secondary outcomes:
measure: Physiological analysis parameter
timeFrame: 24 months follow up
measure: Prognostic factors
timeFrame: 24 months follow up
measure: Physiological analysis, hotspots study
timeFrame: 24 months follow up
measure: Physiological analysis, hotspots study
timeFrame: 24 months follow up
measure: Physiological analysis, hotspots study
timeFrame: 24 months follow up
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest (Hôpital Morvan)
city: Rouen
country: France
facility: Centre Henri Becquerel
Study officials:
References: