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Colorectal CancerDREAMNCT02781935

Diffusion-Weighted MRI for Liver Metastasis

An observational study of Colorectal Cancer and Colon Cancer Liver Metastasis, run by European Organisation for Research and Treatment of Cancer - EORTC at 21 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The DREAM study will assess the diagnostic accuracy of diffusion-weighted MRI in combination with other imaging modalities (multiparametric MRI and CT Scan) in determining the true status of disappearing liver metastasis (DLM) detected after conversion systemic therapy for unresectable or borderline resectable… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
DW-MRI
Type of treatment
Surgery or procedure
How many people
233 participants
Where
21 sitesin 5 countries
Study dates
Nov 2016to 27 Sep 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Primary tumor histologically proven as colorectal adenocarcinoma, colorectal mucinous adenocarcinoma, colorectal signet ring cell carcinoma or colorectal adenosquamous carcinoma Unresectable or borderline resectable liver metastases at the time of diagnosis for liver metastases. Both synchronous and metachronous metastases are allowed Age ≥18 years old With informed consent

Who may be able to join

  • Contrast-enhanced thorax, abdomen and pelvic CT scan (with at least portal venous phase for the liver) at diagnosis and right before surgery are available
  • Multiparametric MRI at baseline and right before surgery are available (T1/T2, DW-MRI and contrast enhanced MRI).
  • WHO performance status of 0 or 1
  • Previous treatments (chemotherapy, surgery) for primary, liver and extra-hepatic metastases are allowed.
  • No other malignancies in the 3 years prior to study entry with the exception of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer gleason score ≤ 6, and basal/squamous cell carcinoma of the skin
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the study
Show all 10Show fewer
  • Criteria for Enrollment
  • Conversion therapy is either being given or completed
  • Patient is suitable for hepatic resection based on the assessment of MDT composed of at least an expert liver/colorectal surgeon, Gastrointestinal (GI) radiologist and oncologist prior to any liver surgery
  • Hepatic resection is scheduled to take place within 8 weeks of latest imaging

Who cannot join

  • Contraindications to any contrast agents for CT and MRI or MRI procedure
  • Pregnancy
  • Significant comorbidity that will preclude either conversion therapy or surgery

Trial locations and contacts

21 sites in 5 countries.

21 sites in 5 countries

Japan13 sites

  • Chiba Cancer Center

    Chiba

  • Gifu University Hospital

    Gifu

  • Hiroshima Prefectural Hospital

    Hiroshima

  • Hyogo College of Medicine

    Hyōgo

  • Niigata Prefectural Cancer Center Hospital

    Niigata

  • Osaka Medical Center for Cancer and Cardiovascular Diseases

    Osaka

  • Gunma Cancer Center

    Ōta-ku

  • Jichi Medical University Saitama Medical Center

    Saitama

  • Shizuoka Cancer Center

    Shizuoka

  • National Cancer Center Hospital

    Tokyo

  • Tokyo Medical and Dental University

    Tokyo

  • Yamagata Prefectural Central Hospital

    Yamagata

  • Kanagawa Cancer Center

    Yokohama

Other trials in Japan

France3 sites

  • Institut Bergonie

    Bordeaux, 33076

  • Centre Leon Berard

    Lyon, 69008

  • Gustave Roussy

    Villejuif

Other trials in France

United States2 sites

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • OHSU Knight Cancer Institute

    Portland, Oregon, 972639-3098

Other trials in United States

Belgium2 sites

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • U.Z. Leuven - Campus Gasthuisberg

    Leuven

Other trials in Belgium

Austria1 site

  • Innsbruck Universitaetsklinik

    Innsbruck

Other trials in Austria

About this study

Official title: Diffusion-Weighted Magnetic Resonance Imaging Assessment of Liver Metastasis to Improve Surgical Planning

The DREAM study will assess the diagnostic accuracy of diffusion-weighted MRI in combination with other imaging modalities (multiparametric MRI and CT Scan) in determining the true status of disappearing liver metastasis (DLM) detected after conversion systemic therapy for unresectable or borderline resectable colorectal liver metastasis (CRLM).

Read the detailed description

The advancements of systemic and local therapies for complex CRLM have led to the increased incidence of DLMs. It is hypothesized that DW-MRI imaging could distinguish between a metastasis not completely sterilized by conversion therapy and a sterilized scar (non-viable tumor). If this can be demonstrated, the use of DW-MRI could make a significant impact on the surgical decision making process by providing surgeons a more reliable guide to decide whether to leave behind or to resect/ablate a site of DLM. Most importantly, this surgical choice can also have a significant impact on patient outcomes as it may impact the risk of local recurrence and the need for re-operation.The possibility of improving surgical management of complex CRLM is foreseen if the benefit of observing or resecting small residual metastases and DLMs is clarified through a multi-center and international prospective study.

Being tested
DW-MRI
Keywords
unresectable colorectal liver metastasis, diffusion weighted MRI, disappearing liver metastasis
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DW-MRIProcedure or surgery

    DW-MRI combined with Contrast Enhanced MRI will be used to confirm the status of disappearing liver metastasis prior to surgery and will be compared to findings from either histopathology of resected lesions (Rubbia-Brandt Classification of Tumor regression grading) or follow-up imaging of lesions left behind (either CT scan or MRI) after surgery. MRI will be used during the follow-up period to confirm recurrences from a previous site of DLM.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Negative Predictive Value (NPV) of the diagnostic imaging (DW-MRI)

    Measured: 2 years after surgery

Secondary outcomes (6)

  1. NPV of diagnostic imaging among the group of resected confirmed DLMs

    Measured: 2 years after the surgery

  2. NPV of diagnostic imaging in the group of confirmed DLMs that were left in place

    Measured: 2 years after ther surgery

  3. NPV of DW-MRI in the group of cDLMs diagnosed by central imaging review

    Measured: 2 years after the surgery

  4. Correlation between different types of morphologic and ADC changes and TRG to the type of conversion therapy

    Measured: 2 years after the surgery

  5. Correlation between findings on DW-MRI to histopathology, recurrence rate, complication rates, PFS and OS

    Measured: 2 years after initial surgery

  6. Long term outcomes of patients who underwent surgery in terms of: - recurrence rates for 2 years after surgery - progression free survival for 2 years after surgery - overall survival for 2 years after surgery

    Measured: 2 years after initial surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2016 (estimated)
  2. Study startNov 2016
  3. Primary completion27 Sep 2023
  4. Study completion27 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
233 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02781935
Sponsor's protocol ID
EORTC-1527-GITCG-IG
Acronym
DREAM
Status last verified
Jan 2024
First submitted
17 May 2016
Last updated
5 Jan 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Kataoka K, Mauer M, Shiozawa M, Marreaud S, Kishi Y, Cabrieto J, Onaya H, Ducreux M, Suto T, Kang HC, Matsuhashi N, Fung A, Yasui M, Rivoire M, Tonooka T, Troisi RI, Nakamura K, Stattner S, Kinugasa Y, Foo WC, Desolneux G, Bonhomme B, Ikeda M, Caballero C, Lordick F, Kanemitsu Y, Evrard S. Diagnostic Accuracy of Imaging in Assessing Nonviability of Disappearing Colorectal Liver Metastasis. JAMA Surg. 2025 Nov 1;160(11):1212-1220. doi: 10.1001/jamasurg.2025.3600.

    PubMed 40960802

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer and Colon Cancer Liver Metastasis, run by European Organisation for Research and Treatment of Cancer - EORTC at 21 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Japan, France, United States, Belgium, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Negative Predictive Value (NPV) of the diagnostic imaging (DW-MRI) (time frame: 2 years after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02781935, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024; AzTrials last refreshed its copy on 27 Oct 2026.

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