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| Name | Class |
|---|---|
| Japan Clinical Oncology Group | OTHER |
| European Society of Surgical Oncology | OTHER |
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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).
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DW-MRI | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Negative Predictive Value (NPV) of the diagnostic imaging (DW-MRI) | 2 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria for Eligibility:
Criteria for Enrollment
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Serge Evrard | Institut Bergonie, France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Portland | Oregon | 972639-3098 | United States | ||
| The University of Texas MD Anderson Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40960802 | Derived | 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. |
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| 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 |
| 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 |
| Houston |
| Texas |
| 77030-4009 |
| United States |
| Innsbruck Universitaetsklinik | Innsbruck | Austria |
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium |
| U.Z. Leuven - Campus Gasthuisberg | Leuven | Belgium |
| Institut Bergonie | Bordeaux | 33076 | France |
| Centre Leon Berard | Lyon | 69008 | France |
| Gustave Roussy | Villejuif | France |
| Chiba Cancer Center | Chiba | Japan |
| Gifu University Hospital | Gifu | Japan |
| Hiroshima Prefectural Hospital | Hiroshima | Japan |
| Hyogo College of Medicine | Hyōgo | Japan |
| Niigata Prefectural Cancer Center Hospital | Niigata | Japan |
| Osaka Medical Center for Cancer and Cardiovascular Diseases | Osaka | Japan |
| Gunma Cancer Center | Ōta-ku | 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 | Japan |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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