Interest of PET/CT at 18F-FDG in the Post-therapeutic Management of Cervical Cancer
- Conditions
- Cervical Cancer
- Registration Number
- NCT04008095
- Lead Sponsor
- University Hospital, Brest
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method collection of the two décisions of RCP Validated by six months follow up To make statistical analysis possible, the collection of the two decisions will be chosen from three cases of care envisaged below:
1. Complete therapeutic response
2. Equivocal response: doubt about the presence of residual disease.
3. Strong suspicion of residual disease and/or progression Then, we will collect a percentage of patients with rightly changes on management induced by the result of the PET-CT at 18F-FDG.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. Validated by six months follow up 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.
Gold Standard for the diagnosis of progression will be based on the conclusions of multi-disciplinary staff ruling on the results of composite data, including clinical examination, biology, histopathology, morphological imaging (MRI), functional imaging (PET/CT) and 6-month follow-up.
- Secondary Outcome Measures
Name Time Method Physiological analysis, hotspots study 24 months follow up Assess the dosimetry of an escalation of the dose on these hotspots.
Prognostic factors 24 months follow up Especially dynamic parameters (SUV max ...) and search for a statistical correlation between this value and PFS and OS.
Physiological analysis parameter 24 months follow up Diagnostic performances of PET/CT, Sensibility, Specificity, positive predictive value, negative predictive value
Trial Locations
- Locations (2)
CHRU de Brest (Hôpital Morvan)
🇫🇷Brest, France
Centre Henri Becquerel
🇫🇷Rouen, France