PRE- MISTIC: MRI and Cine Imaging to Improve Staging of Tumors in the Colon

NCT06216743 | Unknown

• 1 other identifier: 84414
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

At this moment, we use CT and endoscopy to clinically stage colon tumours. Unfortunately, the combination of these imaging techniques is highly inaccurate. 40% of advanced pathological colon tumours (so called T4 tumours) are not staged as a T4 tumour pre-operatively. Preoperative or neoadjuvant chemotherapy (NAC) has improved outcomes in other gastrointestinal cancers and seems to be a promising pretreatment for colon tumours. To implement NACin colon tumours, we first need to stage the colon tumours with much higher accuracy. MRI sequences and cine imaging hold promise to provide more accurate staging of colon tumours.

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of different MRI sequences to diagnose T4 colon carcinoma.

  6 weeks

Secondary Outcomes (2)

• Sensitivity and specificity of different MRI sequences, including diffusion weighted imaging, to diagnose N2 disease, as compared to the golden standard of histological examination.

  6 weeks

• Establishing an MRI Protocol that is optimized for the clinical staging of colon tumors

  6 weeks

Study Arms (1)

Imaging cohort

EXPERIMENTAL

Patients participating in pilot study who will receive an additional MRI-scan, cineMRI and cineCT scan.

Diagnostic Test: MRI and CT

Interventions

MRI and CT DIAGNOSTIC_TEST

Patients will undergo an additional MRI, cineMRI and CineCT cscan.

Imaging cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with clinical suspicion for T3 or T4 tumor based on standard clinical work-up with endoscopy and CT-scan
• Age \> 18 years
• WHO Performance status of 0-2

You may not qualify if:

• Patients with contraindications for MRI
• Patients with clinical contraindications to undergo colon surgery
• Patients receiving neoadjuvant therapy prior to surgery
• Patients with known allergy to iodine or gadolinium contrast
• Patient with contra-indication for contrasts based on kidney failure Neoadjuvant therapy is currently not the standard of care for advanced colon carcinoma, and applied only in selected cases or as part of a clinical trial. Because neoadjuvant therapy could result in tumor regression, thus impacting the gold standard of histological examination, patients selected for neoadjuvant therapy are excluded from this study.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Nijmegen Medical Center

Nijmegen, Gelderland, 6500HB, Netherlands

Location

Related Publications (4)

• Morton D, Seymour M, Magill L, Handley K, Glasbey J, Glimelius B, Palmer A, Seligmann J, Laurberg S, Murakami K, West N, Quirke P, Gray R; FOxTROT Collaborative Group. Preoperative Chemotherapy for Operable Colon Cancer: Mature Results of an International Randomized Controlled Trial. J Clin Oncol. 2023 Mar 10;41(8):1541-1552. doi: 10.1200/JCO.22.00046. Epub 2023 Jan 19.

  PMID: 36657089 BACKGROUND

• Nerad E, Lahaye MJ, Maas M, Nelemans P, Bakers FC, Beets GL, Beets-Tan RG. Diagnostic Accuracy of CT for Local Staging of Colon Cancer: A Systematic Review and Meta-Analysis. AJR Am J Roentgenol. 2016 Nov;207(5):984-995. doi: 10.2214/AJR.15.15785. Epub 2016 Aug 4.

  PMID: 27490941 BACKGROUND

• Brouwer NPM, Stijns RCH, Lemmens VEPP, Nagtegaal ID, Beets-Tan RGH, Futterer JJ, Tanis PJ, Verhoeven RHA, de Wilt JHW. Clinical lymph node staging in colorectal cancer; a flip of the coin? Eur J Surg Oncol. 2018 Aug;44(8):1241-1246. doi: 10.1016/j.ejso.2018.04.008. Epub 2018 Apr 17.

  PMID: 29739638 BACKGROUND

• van den Beukel BAW, Stommel MWJ, van Leuven S, Strik C, IJsseldijk MA, Joosten F, van Goor H, Ten Broek RPG. A Shared Decision Approach to Chronic Abdominal Pain Based on Cine-MRI: A Prospective Cohort Study. Am J Gastroenterol. 2018 Aug;113(8):1229-1237. doi: 10.1038/s41395-018-0158-9. Epub 2018 Jun 27.

  PMID: 29946174 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Richard ten Broek, MD, PhD

CONTACT

+31611469957; Richard.tenbroek@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 22, 2024
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)