ClinicalTrials.gg
CompletedNCT01591590CORIOLANUpdated Oct 26, 2021

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

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

Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.
02

Conditions studied

  • Colorectal Cancer

Keywords

  • Colorectal Cancer
  • Cancer
  • Colon Cancer
  • Rectal Cancer
  • PET
  • PET-CT
  • MRI
  • Diffusion MRI
  • Apparent Diffusion Coefficient
  • ADC
  • Metabolic Progression Index
03

In context

Colorectal Neoplasms

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 →

Lead sponsor

Jules Bordet Institute is the lead sponsor of 106 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

  • 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 during the assessment. For women of childbearing potential a pregnancy test (urinary or serum) must be performed within 7 days prior to inclusion and it must be negative. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately within one month.
  • Signed written informed consent obtained prior to any study specific screening procedures).

Exclusion criteria

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 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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    All Patients

    This is an Interventional, Non Therapeutic arm

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

Interventions

  • OtherFDG PET-CT

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

    Also known as: Metabolic Investigation

  • OtherDiffusion MRI

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

    Also known as: Metabolic Investigation

  • OtherBlood samples (plasma preparation and CTC)
06

What researchers measure

Primary outcomes

  1. Mortality

    Time frame: 12 months

Secondary outcomes

  1. Tumour Progression

    Time frame: 6 months

07

Study locations

1 site
  • Jules Bordet Institute
    Brussels, 1000, Belgium
08

References and documents

Publications

  • 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. PubMed 24885112 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

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.

How these figures are worked out, and which studies are left out of them.

Registered
May 2, 2012
First posted
May 4, 2012
Start
Jun 2012
Primary completionActual
Jul 2019
CompletionActual
Sep 25, 2021
Last update
Oct 26, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01591590
Responsible party
Sponsor
First posted
May 4, 2012
Start date
Jun 2012
Primary completion
Jul 2019
Completion
Sep 25, 2021
Last update
Oct 26, 2021

Study contacts

Amélie Deleporte, MD
principal investigator · Jules Bordet Institute , Universite Libre De Bruxelles

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion