Prospective Pilot Study of Multimodal Radiological Evaluation Feasibility During Chemoradiotherapy of Rectal Adenocarcinomas
|ClinicalTrials.gov Identifier: NCT01619696|
Recruitment Status : Terminated (Insufficient recruitment)
First Posted : June 14, 2012
Last Update Posted : January 23, 2013
|Condition or disease||Intervention/treatment||Phase|
|Rectal Adenocarcinoma||Procedure: Pelvic MRI and F MISO TEP||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Pilot Study of Multimodal Radiological Evaluation Feasibility During Chemoradiotherapy of Rectal Adenocarcinomas.|
|Study Start Date :||March 2011|
|Primary Completion Date :||December 2012|
|Study Completion Date :||December 2012|
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.
- acceptation rate of the entire sequence by eligible patients [ Time Frame: 13 weeks ]acceptation rate of the entire sequence by eligible patients
- radiological changes while on chimiotherapy, to tumour regression, and prognosis [ Time Frame: 13 weeks ]radiological changes while on chimiotherapy, to tumour regression, and prognosis
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01619696
|Toulouse, France, 31059|
|Principal Investigator:||Guillaume Portier, PhD||CHU Toulouse|