Diagnostic Performance of 18F-FDG-PET and Diffusion-weighted MRI in the Assessment of Stage IB to IIB2 Cervical Squamous-cell Carcinoma Response to Concomitant Radiochemotherapy and Brachytherapy

Study Overview
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Brief Summary
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Rationale: The benefit-risk ratio of surgery following concomitant radiochemotherapy and brachytherapy remains to be defined in cervical squamous-cell carcinoma (SCC) treatment. Scarce studies evaluated the interest of 18F-FDG-PET and MRI in the assessment of response to treatment before surgery. A positive predictive value of 75% was found in a small study making 18F-FDG-PET a promising tool to assess tumor response and guide surgical approach. Diffusion-weighted MRI was also described as an early and sensitive indicator in other diseases. Objectives: The main objective of this study is to evaluate the sensitivity of 18F-FDG-PET in the assessment of cervical cancer response to radiochemotherapy and brachytherapy. Secondary objectives focus on 18F-FDG-PET specificity and likehood ratios as well as diffusion-weighted MRI diagnostic performances. Method: We will conduct a prospective cohort study of 148 women with a stage IB to IIB2 cervical SCC recruited over 2.5 years in 24 centers in France. Each patient will undergo a 18F-FDG-PET and a diffusion-weighted MRI before surgery and 8 weeks after completion of the brachytherapy. The total follow-up duration (study participation) of patients will be 11 weeks : inclusion after completion of radiochemotherapy and brachytherapy, 8 weeks until 18F-FDG-PET and diffusion-weighted MRI, and 3 weeks until surgery. Expected results: 18F-FDG-PET and diffusion-weighted MRI could constitute a reliable tool to assess response to radiochemotherapy and brachytherapy in cervical SCC treatment. If so it could improve clinical practices and be helpful to decide whether the patient needs surgery or not after radiochemotherapy and brachytherapy.

Official Title
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Diagnostic Performance of 18F-FDG-PET and Diffusion-weighted MRI in the Assessment of Stage IB to IIB2 Cervical Squamous-cell Carcinoma Response to Concomitant Radiochemotherapy and Brachytherapy

Conditions
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Cancer of the Uterine Cervix

Intervention / Treatment
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* Device: 18F-FDG-PET


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients 18 years of age or older Biopsy-confirmed cervical squamous-cell carcinomas Stage IB2, IIA ou IIB according to the FIGO staging of cervical carcinomas No spread to lumbo-aortic lymph nodes No prior pelvic radiotherapy No prior cancer treatment WHO Performance status less than or equal to 1 Beneficiary of a health insurance Must provide her signed and informed consent Exclusion Criteria: Reccurent or Metastasized cancer History of uncontrolled cancer, or any cancer treated for less than 5 years (except basal cell carcinomas) Any contraindication to MRI Know hypersensitivity to Gadolinium, 18F-FDG or one of the excipients Pregnant or breast feeding patients Participation in any other clinical trial that could interfere with the study results Any geographical, social or psychical reasons that could prohibit the ability to return for follow-up assessment

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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-FDG-PET<br>The 18F-FDG-PET will be performed 8 weeks following completion of brachytherapy (date of inclusion) | Device: 18F-FDG-PET<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of 18F-FDG-PET in the assessment of stage IB to IIB2 cervical squamous-cell carcinoma response to concomitant radiochemotherapy and brachytherapy | A centralized review will be carried out by 2 independant reviewers, additionally to the initial interpretation. The gold-standard to evaluate tumoral response to radiochemotherapy and brachytherapy will be the anatomopathologic analysis of the hysterectomy piece after surgery. The18F-FDG-PET will be performed 8 weeks following completion of brachytherapy (date of inclusion)and surgery will be performed within 3 weeks after the 18F-FDG-PET. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity and likehood ratios of 18F-FDG-PET in the assessment of stage IB to IIB2 cervical squamous-cell carcinoma response to concomitant radiochemotherapy and brachytherapy |  | 8 weeks | 
| Diagnostic performances of diffusion-wheighed MRI in the assessment of stage IB to IIB2 cervical squamous-cell carcinoma response to concomitant radiochemotherapy and brachytherapy |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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2-fluoro-2-deoxy-d-glucose-positron emission tomography, Positron emission tomography, Magnetic resonance imaging, Diffusion weighted MRI, Squamous-cell cervical carcinoma, Sensitivity