Diffusion-Weighted MRI for Liver Metastasis

Colorectal Cancer Clinical Trial

— DREAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02781935
• Other study ID #: EORTC-1527-GITCG-IG
• Status: Completed
• Start date: November 2016
• Est. completion date: September 27, 2023

Study information

• Verified date: January 2024
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 colorectal liver metastasis (CRLM).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: September 27, 2023
• Est. primary completion date: September 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Colon Cancer Liver Metastasis
• Colorectal Cancer
• Liver Neoplasms
• Malignant Neoplasm of Rectum Metastatic to Liver
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary
• Rectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Austria	Innsbruck Universitaetsklinik	Innsbruck
Belgium	Universitair Ziekenhuis Gent	Ghent
Belgium	U.Z. Leuven - Campus Gasthuisberg	Leuven
France	Institut Bergonie	Bordeaux
France	Centre Leon Berard	Lyon
France	Gustave Roussy	Villejuif
Japan	Chiba Cancer Center	Chiba
Japan	Gifu University Hospital	Gifu
Japan	Hiroshima Prefectural Hospital	Hiroshima
Japan	Hyogo College of Medicine	Hyogo
Japan	Niigata Prefectural Cancer Center Hospital	Niigata
Japan	Osaka Medical Center for Cancer and Cardiovascular Diseases	Osaka
Japan	Gunma Cancer Center	Ota-City
Japan	Jichi Medical University Saitama Medical Center	Saitama
Japan	Shizuoka Cancer Center	Shizuoka
Japan	National Cancer Center Hospital	Tokyo
Japan	Tokyo Medical and Dental University	Tokyo
Japan	Yamagata Prefectural Central Hospital	Yamagata
Japan	Kanagawa Cancer Center	Yokohama
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC	European Society of Surgical Oncology, Japan Clinical Oncology Group

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  France,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Negative Predictive Value (NPV) of the diagnostic imaging (DW-MRI)		2 years after surgery
Secondary	NPV of diagnostic imaging among the group of resected confirmed DLMs		2 years after the surgery
Secondary	NPV of diagnostic imaging in the group of confirmed DLMs that were left in place		2 years after ther surgery
Secondary	NPV of DW-MRI in the group of cDLMs diagnosed by central imaging review		2 years after the surgery
Secondary	Correlation between different types of morphologic and ADC changes and TRG to the type of conversion therapy		2 years after the surgery
Secondary	Correlation between findings on DW-MRI to histopathology, recurrence rate, complication rates, PFS and OS		2 years after initial surgery
Secondary	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		2 years after initial surgery