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Diffusion-Weighted MRI for Liver Metastasis (DREAM)

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ClinicalTrials.gov Identifier: NCT02781935
Recruitment Status : Recruiting
First Posted : May 25, 2016
Last Update Posted : September 2, 2020
Sponsor:
Collaborators:
Japan Clinical Oncology Group
European Society of Surgical Oncology
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

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).

Condition or disease Intervention/treatment
Colorectal Cancer Colon Cancer Liver Metastasis Malignant Neoplasm of Rectum Metastatic to Liver Procedure: DW-MRI

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.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diffusion-Weighted Magnetic Resonance Imaging Assessment of Liver Metastasis to Improve Surgical Planning
Study Start Date : November 2016
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: DW-MRI
    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.


Primary Outcome Measures :
  1. Negative Predictive Value (NPV) of the diagnostic imaging (DW-MRI) [ Time Frame: 2 years after surgery ]

Secondary Outcome Measures :
  1. NPV of diagnostic imaging among the group of resected confirmed DLMs [ Time Frame: 2 years after the surgery ]
  2. NPV of diagnostic imaging in the group of confirmed DLMs that were left in place [ Time Frame: 2 years after ther surgery ]
  3. NPV of DW-MRI in the group of cDLMs diagnosed by central imaging review [ Time Frame: 2 years after the surgery ]
  4. Correlation between different types of morphologic and ADC changes and TRG to the type of conversion therapy [ Time Frame: 2 years after the surgery ]
  5. Correlation between findings on DW-MRI to histopathology, recurrence rate, complication rates, PFS and OS [ Time Frame: 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 [ Time Frame: 2 years after initial surgery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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

Criteria

Inclusion Criteria for Eligibility:

  1. 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
  2. Multiparametric MRI at baseline and right before surgery are available (T1/T2, DW-MRI and contrast enhanced MRI).
  3. WHO performance status of 0 or 1
  4. Previous treatments (chemotherapy, surgery) for primary, liver and extra-hepatic metastases are allowed.
  5. 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
  6. 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

  1. Conversion therapy is either being given or completed
  2. 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
  3. Hepatic resection is scheduled to take place within 8 weeks of latest imaging

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781935


Contacts
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Contact: EORTC HQ +32 2 774 1611 1527@eortc.org

Locations
Show Show 24 study locations
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Japan Clinical Oncology Group
European Society of Surgical Oncology
Investigators
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Study Chair: Serge Evrard Institut Bergonie, France
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT02781935    
Other Study ID Numbers: EORTC-1527-GITCG-IG
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
unresectable colorectal liver metastasis
diffusion weighted MRI
disappearing liver metastasis
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Neoplasms
Rectal Neoplasms
Body Weight
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases