Prospective Pilot Study of Multimodal Radiological Evaluation Feasibility During Chemoradiotherapy of Rectal Adenocarcinomas
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|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|
|Actual Primary Completion Date :||December 2012|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01619696
|Toulouse, France, 31059|
|Principal Investigator:||Guillaume Portier, PhD||CHU Toulouse|