Prospective Pilot Study of Multimodal Radiological Evaluation Feasibility During Chemoradiotherapy of Rectal Adenocarcinomas
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Prospective Pilot Study of Multimodal Radiological Evaluation Feasibility During Chemoradiotherapy of Rectal Adenocarcinomas.|
- acceptation rate of the entire sequence by eligible patients [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]acceptation rate of the entire sequence by eligible patients
- radiological changes while on chimiotherapy, to tumour regression, and prognosis [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]radiological changes while on chimiotherapy, to tumour regression, and prognosis
|Study Start Date:||March 2011|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Procedure: Pelvic MRI and F MISO TEP
Pelvic MRI and F MISO TEP: before inclusion, 2 weeks after beginning and 7 weeks after completion of chemoradiotherapy.
The objective of the present project is to validate the feasibility of a multimodal radiological pathway while on chemoradiotherapy, in order to validate potentially predictive factors for chemoradiotherapy sensitivity of rectal adenocarcinomas.
It is based on a structured clinical and radiological pathway for patients, using diffusion MRI and F misonidazole PET.
Validation of these new tools is already needed in clinical practice since future institutional trials will be based on treatment individualisation, using preoperative predicting factors.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619696
|Toulouse, France, 31059|
|Principal Investigator:||Guillaume Portier, PhD||CHU Toulouse|