Correlating the Tumoral Metabolic Progression Index to Patient's Outcome in Advanced Colorectal Cancer (CORIOLAN)
The purpose of this study is to assess whether in a population of patients with advanced colorectal cancer for which no known effective therapy is available, measuring the spontaneous evolution of tumoral metabolic progression index by serial FGD PET-CT and Diffusion MRI can show that tumor growth rate is related to the patient's outcome, and that serial FDG PET-CT and Diffusion MRI are able to measure it.
Other: FDG PET-CT
Other: Diffusion MRI
Other: Blood samples (plasma preparation and CTC)
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Correlating the Tumoral Metabolic Progression Index Measured by Serial FDG PET-CT and Apparent Diffusion Coefficient Measured by MRI to Patient's Outcome in Advanced Colorectal Cancer|
- Mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Tumour Progression [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: All Patients
This is an Interventional, Non Therapeutic arm
Other: FDG PET-CT
All patients will undergo FDG PET-CT at inclusion and 2 weeks after
Other Name: Metabolic InvestigationOther: Diffusion MRI
All patients will undergo Diffusion MRI at inclusion and 2 weeks later
Other Name: Metabolic InvestigationOther: Blood samples (plasma preparation and CTC)
Natural history of tumors is a poorly studied subject, the clinical evidence of some tumors aggressiveness as opposed to some other's indolent behavior has never been formally assessed in daily practice or in clinical studies and remains largely unpredictable. The patient's populations are in fact a mix between different tumoral phenotypes that while carrying the same apparent disease evolve with different outcomes.
We hypothesize that,in a population of patients with advanced colorectal cancer for which no known effective therapy is available, measuring the spontaneous evolution of tumoral metabolic progression index by serial FGD PET-CT and Diffusion MRI can show that tumor growth rate is related to the patient's outcome, and that serial FDG PET-CT and Diffusion MRI are able to measure it.
If the hypothesis is verified, this finding could:
- Allow to define therapeutic strategies according to the tumoral metabolic progression index.
- Limit the need for randomization in the early drug development phases as each patient could be considered as his own control.
- To stratify patients according to their baseline metabolic growth rate in randomized controlled trials with overall survival as an endpoint.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01591590
|Contact: Amélie Deleporte, MD||+32 0 2 541 35 firstname.lastname@example.org|
|Contact: Patrick Flamen, MD, PHD||+32 0 2 541 37 email@example.com|
|Jules Bordet Institute||Recruiting|
|Brussels, Belgium, 1000|
|Contact: Amélie Deleporte, MD +32 0 2 541 35 41 firstname.lastname@example.org|
|Contact: Patrick Flamen, MD,PHD +32 0 2 541 37 17 email@example.com|
|Sub-Investigator: Alain Hendlisz, MD|
|Sub-Investigator: Patrick Flamen, MD, PHD|
|Sub-Investigator: Jean-Luc Engelholm, MD|
|Sub-Investigator: Godelieve Machiels, MD|
|Sub-Investigator: Angelique Covas, MD|
|Sub-Investigator: Camilo Garcia, MD, ORILAB|
|Sub-Investigator: Bruno Vanderlinden, Physicist|
|Sub-Investigator: Thomas Guiot, Ir ORILAB|
|Sub-Investigator: Hazem El Mansy, MD|
|Sub-Investigator: Marc Lemort, MD|
|Sub-Investigator: Laura Belenguer Querol, Ir, ORILAB|
|Principal Investigator:||Amélie Deleporte, MD||Jules Bordet Institute , Universite Libre De Bruxelles|