Clinical trial · Interventional
An Investigational Scan (Intravoxel Incoherent Motion Diffusion Weighted Imaging) for the Evaluation of Colorectal Cancer Liver Metastases Treatment Response
Evaluation of Treatment Response of Colorectal Cancer Liver Metastases With Intravoxel Incoherent Motion Diffusion Weighted Imaging
NCT04796818CI-TRIAL-00118664recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This trial evaluates the treatment response of colorectal cancer that has spread to the liver (liver metastases) using intravoxel incoherent motion diffusion weighted imaging (IVIM DWI). IVIM DWI is new kind of imaging scan that may help measure changes in disease before and after chemotherapy in patients with colorectal liver metastases.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Carcinoma | Colorectal Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Malignant Neoplasm in the Liver | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
| Resectable Colorectal Carcinoma | Colorectal Carcinoma | CURATED_BROADER | 0.78 |
| Stage IVA Colorectal Cancer AJCC v8 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Stage IVB Colorectal Cancer AJCC v8 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Stage IVC Colorectal Cancer AJCC v8 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Stage IV Colorectal Cancer AJCC v8 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diffusion Weighted Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (IVIM DWI)
- description
- Patients undergo IVIM DWI over 10 minutes during standard of care MRI within 30 days of starting chemotherapy and after 4-6 cycles of preoperative chemotherapy.
- interventionNames
- Procedure: Diffusion Weighted Imaging
Primary outcomes (1)
- measure
- Absolute change in the true diffusion coefficient (D)
- timeFrame
- Up to 3 months or 5 months (each cycle is 28 days)
- description
- The absolute changes of parameter D between response and nonresponse groups will be compared using a two-sample t-test.
Secondary outcomes (1)
- measure
- Diffusion related parameters in intravoxel incoherent motion diffusion weighted imaging
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with treatment-naive resectable CLM, who will start chemotherapy with oxaliplatin with fluorouracil (5-FU)/leucovorin (FOLFOX), irinotecan with 5-FU/leucovorin (FOLFIRI), or a combination, such as fluorouracil, leucovorin, oxaliplatin and irinotecan (FOLFOXIRI), with or without a biologic agent * Patients with at least 1 colorectal liver metastasis measuring at least 1 cm * Patients with anticipated follow-up before and after surgery at MD Anderson Exclusion Criteria: * Patients who have already received preoperative chemotherapy for the CLM or will undergo radiation therapy, ablative therapies, or other non-surgical therapies directed at the liver * Patients allergic to gadolinium * Patients with pacemakers * Greater than 400 pounds in weight
References
Publications (0)
Data not yet available
No reference posted for this study.