An interventional study of FDG PET-CT and Diffusion MRI in Colorectal Cancer, sponsored by Jules Bordet Institute. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-26.
Sponsored by Jules Bordet Institute · Not applicable, Interventional, and Diagnostic
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.
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:
5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.
This study's enrollment of 53 is below the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Jules Bordet Institute is the lead sponsor of 106 studies on the registry; 28 are open to participants now.
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Total bilirubin within 2 × normal institutional upper limits AST/ALT/Alk Phosphatase levels \< 5 × normal institutional upper limits Creatinine within 2 × normal institutional upper limits or creatinine clearance > 35mL/min
Exclusion Criteria:
Patients who exhibit any of the following conditions at screening will not be eligible for admission into the study:
This is an Interventional, Non Therapeutic arm
Other: FDG PET-CT · Other: Diffusion MRI · Other: Blood samples (plasma preparation and CTC)
All patients will undergo FDG PET-CT at inclusion and 2 weeks after
Also known as: Metabolic Investigation
All patients will undergo Diffusion MRI at inclusion and 2 weeks later
Also known as: Metabolic Investigation
Mortality
Time frame: 12 months
Tumour Progression
Time frame: 6 months
The record gives a start of Jun 2012, a primary completion of Jul 2019 and a completion of Sep 2021. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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