NCT02781935

Brief 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 colorectal liver metastasis (CRLM).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
233

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Longer than P75 for all trials

Geographic Reach
5 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 25, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2023

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

6.9 years

First QC Date

May 17, 2016

Last Update Submit

January 4, 2024

Conditions

Colorectal CancerColon Cancer Liver MetastasisMalignant Neoplasm of Rectum Metastatic to Liver

Keywords

unresectable colorectal liver metastasisdiffusion weighted MRIdisappearing liver metastasis

Outcome Measures

Primary Outcomes (1)

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

    2 years after surgery

Secondary Outcomes (6)

  • NPV of diagnostic imaging among the group of resected confirmed DLMs

    2 years after the surgery

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

    2 years after ther surgery

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

    2 years after the surgery

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

    2 years after the surgery

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

    2 years after initial surgery

  • +1 more secondary outcomes

Interventions

DW-MRIPROCEDURE

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

OHSU Knight Cancer Institute

Portland, Oregon, 972639-3098, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Innsbruck Universitaetsklinik

Innsbruck, Austria

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

U.Z. Leuven - Campus Gasthuisberg

Leuven, Belgium

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Leon Berard

Lyon, 69008, France

Location

Gustave Roussy

Villejuif, France

Location

Chiba Cancer Center

Chiba, Japan

Location

Gifu University Hospital

Gifu, Japan

Location

Hiroshima Prefectural Hospital

Hiroshima, Japan

Location

Hyogo College of Medicine

Hyōgo, Japan

Location

Niigata Prefectural Cancer Center Hospital

Niigata, Japan

Location

Osaka Medical Center for Cancer and Cardiovascular Diseases

Osaka, Japan

Location

Gunma Cancer Center

Ōta-ku, Japan

Location

Jichi Medical University Saitama Medical Center

Saitama, Japan

Location

Shizuoka Cancer Center

Shizuoka, Japan

Location

National Cancer Center Hospital

Tokyo, Japan

Location

Tokyo Medical and Dental University

Tokyo, Japan

Location

Yamagata Prefectural Central Hospital

Yamagata, Japan

Location

Kanagawa Cancer Center

Yokohama, Japan

Location

Related Publications (1)

  • 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.

    PMID: 40960802DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Serge Evrard

    Institut Bergonie, France

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2016

First Posted

May 25, 2016

Study Start

November 1, 2016

Primary Completion

September 27, 2023

Study Completion

September 27, 2023

Last Updated

January 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)JP(13)BE(2)FR(3)AU(1)