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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

Phase 2
18 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

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

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

- 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.

Inclusion Criteria:

- Participants must have histologically confirmed colorectal cancer that is metastatic
or unresectable and for which standard treatments do not exist or are no longer

- All standard chemotherapy agents (fluoropyrimidines, irinotecan and oxaliplatin) and
monoclonal antibodies (bevacizumab, cetuximab and panitumumab) are allowed as
administered therapy before study entry.

- 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

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control, abstinence) prior to study entry and
for the duration of study participation. Should a woman become pregnant or suspect
she is pregnant while participating in this study, she must inform her treating
physician immediately.

- Signed written informed consent (approved by an Independent Ethics Committee (IEC)
and obtained prior to any study specific screening procedures).

Exclusion Criteria:

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 4 weeks prior to entering
the study or those who have not recovered from adverse events due to agents
administered more than 4 weeks earlier.

- Patients receiving any experimental agents.

- Patients with uncontrolled brain metastases.

- Bleeding diathesis, history of cardiovascular ischemic disease or cerebrovascular
incident within the last six months.

- Major surgery within four weeks.

- 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 (absence to be confirmed by urinary test on the days of the FDG PET-CT scan
examinations) or breastfeeding.

- 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.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:


Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Amélie Deleporte, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jules Bordet Institute , Universite Libre De Bruxelles


Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:




Start Date:

June 2012

Completion Date:

May 2014

Related Keywords:

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