Clinical trial · Interventional
Diagnostic Value of Diffusion-weighted Magnetic Resonance in High-risk Colorectal and Appendiceal Neoplasms
Diagnostic Value of Diffusion-weighted Magnetic Resonance Imaging for Detection of Peritoneal Recurrence in Patients With High-risk Colorectal and Appendiceal Neoplasms : a Pilot Study
- 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)
Diffusion-weighted magnetic resonance imaging (DWI/MRI) has been described in recent literature as a highly sensitive and specific modality for the detection of peritoneal metastases PM. It has been demonstrated to be superior to CT for patients with known peritoneal disease from colorectal and gynaecological malignancies as a staging tool for cytoreductive surgery. It was also demonstrated to be superior for the detection of PM for gastric cancer patients otherwise considered with a resectable tumor. However, the literature is scarce on the role of DWI/MRI in the detection of peritoneal recurrence for patients with high-risk features, either colorectal cancer (CRC) or appendiceal neoplasms (AN). The aim of this study is to prospectively assess the added value of whole-body DWI/MRI (WB-DWI/MRI) to CT and diagnostic laparoscopy for detection of PM in the follow-up of patients presenting with CRC or AN and high-risk features for peritoneal recurrence and evaluate how it correlates with intraoperative findings.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Appendix Cancer | Malignant Appendix Neoplasm | ALIAS | 0.90 |
| Appendix Neoplasm | Appendix Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Peritoneal Carcinomatosis | Peritoneal Carcinomatosis | ONTOLOGY_EXACT | 0.98 |
| Peritoneal Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Whole-body diffusion-weighted magnetic resonance imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DWI-High Risk
- description
- Patients to undergo DWI-MRI (patients included in the study).
- interventionNames
- Diagnostic Test: Whole-body diffusion-weighted magnetic resonance imaging
Primary outcomes (2)
- measure
- Peritoneal findings
- timeFrame
- 24 months
- description
- The number of cases in which peritoneal findings on MRI matched with surgical exploration.
- measure
- Early peritoneal recurrence
- timeFrame
- 36 months
- description
- The number of cases with early peritoneal recurrence after MRI.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of colorectal cancer or high-risk appendiceal neoplasm (High grade Appendiceal Mucinous Neoplasm (HAMN), goblet-cell carcinoma or adenocarcinoma). * No evidence of residual peritoneal disease based on referring surgeon operating report and preoperative imaging. * At least one high-risk feature for peritoneal recurrence, including: * Synchronous peritoneal metastases resected at index surgery; * Synchronous ovarian metastases resected at index surgery; * Perforated primary tumor. * No evidence of distant metastases. * Patient fit for cytoreductive surgery, if required (ECOG 0 or 1). Exclusion Criteria: * Unresected synchronous peritoneal metastases at referral. * Low grade Appendiceal Mucinous Neoplasm (LAMN). * No high-risk feature for peritoneal recurrence. * Evidence of distant metastases on preoperative imaging. * Patient who is unable to have MRI. * Patient unfit for cytoreductive surgery, if required (ECOG 2 or more).
References
Publications (25)
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- BACKGROUNDMassalou D, Benizri E, Chevallier A, Duranton-Tanneur V, Pedeutour F, Benchimol D, Bereder JM. Peritoneal carcinomatosis of colorectal cancer: novel clinical and molecular outcomes. Am J Surg. 2017 Feb;213(2):377-387. doi: 10.1016/j.amjsurg.2016.03.008. Epub 2016 Aug 5. PMID 27816197
- BACKGROUNDSugarbaker PH. Colorectal cancer: prevention and management of metastatic disease. Biomed Res Int. 2014;2014:782890. doi: 10.1155/2014/782890. Epub 2014 Mar 24. PMID 24783222
- BACKGROUNDGoere D, Glehen O, Quenet F, Guilloit JM, Bereder JM, Lorimier G, Thibaudeau E, Ghouti L, Pinto A, Tuech JJ, Kianmanesh R, Carretier M, Marchal F, Arvieux C, Brigand C, Meeus P, Rat P, Durand-Fontanier S, Mariani P, Lakkis Z, Loi V, Pirro N, Sabbagh C, Texier M, Elias D; BIG-RENAPE group. Second-look surgery plus hyperthermic intraperitoneal chemotherapy versus surveillance in patients at high risk of developing colorectal peritoneal metastases (PROPHYLOCHIP-PRODIGE 15): a randomised, phase 3 study. Lancet Oncol. 2020 Sep;21(9):1147-1154. doi: 10.1016/S1470-2045(20)30322-3. Epub 2020 Jul 24. PMID 32717180
- BACKGROUNDKlaver CEL, Wisselink DD, Punt CJA, Snaebjornsson P, Crezee J, Aalbers AGJ, Brandt A, Bremers AJA, Burger JWA, Fabry HFJ, Ferenschild F, Festen S, van Grevenstein WMU, Hemmer PHJ, de Hingh IHJT, Kok NFM, Musters GD, Schoonderwoerd L, Tuynman JB, van de Ven AWH, van Westreenen HL, Wiezer MJ, Zimmerman DDE, van Zweeden AA, Dijkgraaf MGW, Tanis PJ; COLOPEC collaborators group. Adjuvant hyperthermic intraperitoneal chemotherapy in patients with locally advanced colon cancer (COLOPEC): a multicentre, open-label, randomised trial. Lancet Gastroenterol Hepatol. 2019 Oct;4(10):761-770. doi: 10.1016/S2468-1253(19)30239-0. Epub 2019 Jul 29. PMID 31371228