Clinical trial NCT02781935: Diffusion-Weighted MRI for Liver Metastasis
Official title: Diffusion-Weighted Magnetic Resonance Imaging Assessment of Liver Metastasis to Improve Surgical Planning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Colon Cancer Liver Metastasis
Malignant Neoplasm of Rectum Metastatic to Liver
Keywords: unresectable colorectal liver metastasis
diffusion weighted MRI
disappearing liver metastasis
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
Collaborators: name: Japan Clinical Oncology Group
name: European Society of Surgical Oncology
First posted: 2016-05-25
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).

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.

Eligibility 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

Primary outcomes:
measure: Negative Predictive Value (NPV) of the diagnostic imaging (DW-MRI)
timeFrame: 2 years after surgery
Secondary outcomes:
measure: NPV of diagnostic imaging among the group of resected confirmed DLMs
timeFrame: 2 years after the surgery
measure: NPV of diagnostic imaging in the group of confirmed DLMs that were left in place
timeFrame: 2 years after ther surgery
measure: NPV of DW-MRI in the group of cDLMs diagnosed by central imaging review
timeFrame: 2 years after the surgery
measure: Correlation between different types of morphologic and ADC changes and TRG to the type of conversion therapy
timeFrame: 2 years after the surgery
measure: Correlation between findings on DW-MRI to histopathology, recurrence rate, complication rates, PFS and OS
timeFrame: 2 years after initial surgery
measure: 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
timeFrame: 2 years after initial surgery
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Innsbruck
country: Austria
facility: Innsbruck Universitaetsklinik
city: Ghent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: U.Z. Leuven - Campus Gasthuisberg
city: Bordeaux
country: France
facility: Institut Bergonie
city: Lyon
country: France
facility: Centre Leon Berard
city: Villejuif
country: France
facility: Gustave Roussy
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Gifu
country: Japan
facility: Gifu University Hospital
city: Hiroshima
country: Japan
facility: Hiroshima Prefectural Hospital
city: Hyōgo
country: Japan
facility: Hyogo College of Medicine
city: Niigata
country: Japan
facility: Niigata Prefectural Cancer Center Hospital
city: Osaka
country: Japan
facility: Osaka Medical Center for Cancer and Cardiovascular Diseases
city: Ota-City
country: Japan
facility: Gunma Cancer Center
city: Saitama
country: Japan
facility: Jichi Medical University Saitama Medical Center
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical and Dental University
city: Yamagata
country: Japan
facility: Yamagata Prefectural Central Hospital
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center
Study officials:
affiliation: Institut Bergonie, France
name: Serge Evrard
role: STUDY_CHAIR
References: