Clinical trial · Observational
Diffusion-Weighted MRI for Liver Metastasis
Diffusion-Weighted Magnetic Resonance Imaging Assessment of Liver Metastasis to Improve Surgical Planning
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer Liver Metastasis | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Malignant Neoplasm of Rectum Metastatic to Liver | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DW-MRI | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Negative Predictive Value (NPV) of the diagnostic imaging (DW-MRI)
- timeFrame
- 2 years after surgery
Secondary outcomes (6)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKataoka 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 40960802