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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 :
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
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| 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
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:
| Validated by six months follow up |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Women recently diagnosed for an advanced cervical cancer (FIGO 2019 IB3 to IVA), and histologically proved.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Brest (Hôpital Morvan) | Brest | 29200 | France | |||
| Centre Henri Becquerel |
All collected data that underlie results in a publication
Data will be available after the publication of result and ending three years maximum following the last visit of the last patient
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data accesss agreement
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| 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 |
| Rouen |
| 76038 |
| France |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |