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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cervical Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. 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. | Validated by six months follow up | 
| collection of the two décisions of RCP | To make statistical analysis possible, the collection of the two decisions will be chosen from three cases of care envisaged below: Complete therapeutic response Equivocal response: doubt about the presence of residual disease. 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. | Validated by six months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological analysis parameter | Diagnostic performances of PET/CT, Sensibility, Specificity, positive predictive value, negative predictive value | 24 months follow up | 
| Prognostic factors | Especially dynamic parameters (SUV max ...) and search for a statistical correlation between this value and PFS and OS. | 24 months follow up | 
| Physiological analysis, hotspots study | Hotspots study - Search for a density intersection between the local site residual disease of post-therapeutic 18F-FDG PET/CT and maximum-fixing tumor sites in 18F-FDG PET/CT Baseline. | 24 months follow up | 
| Physiological analysis, hotspots study | Hotspots study - Search maximum-fixing tumor sites in 18F-FDG PET/CT Baseline | 24 months follow up | 
| Physiological analysis, hotspots study | Assess the dosimetry of an escalation of the dose on these hotspots. | 24 months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical cancer, pet/ct, post-therapeutic, advanced stage, management