Correlating the Tumoral Metabolic Progression Index to Patient's Outcome in Advanced Colorectal Cancer

NCT01591590 | Completed

• 2 other identifiers: CORIOLAN2011-006280-21
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

Colorectal Cancer; Cancer; Colon Cancer; Rectal Cancer; PET; PET-CT; MRI; Diffusion MRI; Apparent Diffusion Coefficient; ADC; Metabolic Progression Index

Outcome Measures

Primary Outcomes (1)

• Mortality

  12 months

Secondary Outcomes (1)

• Tumour Progression

  6 months

Study Arms (1)

All Patients

EXPERIMENTAL

This is an Interventional, Non Therapeutic arm

Other: FDG PET-CT; Other: Diffusion MRI; Other: Blood samples (plasma preparation and CTC)

Interventions

FDG PET-CT OTHER

All patients will undergo FDG PET-CT at inclusion and 2 weeks after

Also known as: Metabolic Investigation

All Patients

Diffusion MRI OTHER

All patients will undergo Diffusion MRI at inclusion and 2 weeks later

Also known as: Metabolic Investigation

All Patients

Blood samples (plasma preparation and CTC) OTHER

All Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have histologically confirmed colorectal cancer that is metastatic or unresectable and for which standard treatments do not exist or are no longer effective.
• The tumor should be refractory to all standard chemotherapy agents (fluoropyrimidines, irinotecan, and oxaliplatin) and anti-EGFR monoclonal antibodies in case of wild type Kras (cetuximab or panitumumab) administered before study entry. Prior treatment with bevacizumab, regorafenib and/or aflibercept is allowed but not mandatory
• Participants should be candidate for a Phase I study
• Age equal or over 18 years.
• Life expectancy of greater than 12 weeks.
• ECOG performance status ≤ 1.
• Participants must have normal organ and marrow function as defined below:
• 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
• Signed written informed consent obtained prior to any study specific screening procedures).

You may not qualify if:

• Patients who exhibit any of the following conditions at screening will not be eligible for admission into the study:
• Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.
• Participants who have had a major surgery or radiotherapy within 4 weeks prior to entering the study.
• Patients receiving any experimental agents during the assessment time period.
• Patients with uncontrolled brain metastases.
• Bleeding diathesis, history of cardiovascular ischemic disease or cerebrovascular incident within the last six months.
• Participants who have had a major surgery or radiotherapy within 4 weeks prior to entering the study
• Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness or any significant disease which, in the investigator's opinion, would exclude the patient from the study.
• Pregnancy or breastfeeding before the FDG PET-CT scan examinations
• Uncontrolled Diabetes.
• Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
• Contra-indications to the use of MRI: cardiac stimulator, implanted cardiac wires, any implanted electronic devices, intra-ocular metallic foreign bodies.
• Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent.

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (1)

Jules Bordet Institute

Brussels, 1000, Belgium

Location

Related Publications (1)

• Deleporte A, Paesmans M, Garcia C, Vandeputte C, Lemort M, Engelholm JL, Hoerner F, Aftimos P, Awada A, Charette N, Machiels G, Piccart M, Flamen P, Hendlisz A. Correlating tumor metabolic progression index measured by serial FDG PET-CT, apparent diffusion coefficient measured by magnetic resonance imaging (MRI) and blood genomics to patient's outcome in advanced colorectal cancer: the CORIOLAN study. BMC Cancer. 2014 May 30;14:385. doi: 10.1186/1471-2407-14-385.

  PMID: 24885112 DERIVED

Related Links

• Jules Bordet Institute

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Diffusion Tensor Imaging; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative

Study Officials

• Amélie Deleporte, MD

  Jules Bordet Institute , Universite Libre De Bruxelles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2012
• First Posted: May 4, 2012
• Study Start: June 1, 2012
• Primary Completion: July 1, 2019
• Study Completion: September 25, 2021
• Last Updated: October 26, 2021

Record last verified: 2018-11

Locations

BE (1)