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

Not Applicable

Not yet recruiting

• Conditions: Colon Cancer
• Interventions: Diagnostic Test: MRI and CT

• Registration Number: NCT06216743
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-11
• Study First Submitted QC: 2024-01-11
• Study First Posted: 2024-01-22
• Last Update Submitted: 2024-12-30
• Last Update Posted: 2024-12-31
• Study Start: 2025-01-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• 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

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Imaging cohort	MRI and CT	Patients participating in pilot study who will receive an additional MRI-scan, cineMRI and cineCT scan.

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of different MRI sequences to diagnose T4 colon carcinoma.	6 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Center; 🇳🇱 Nijmegen, Gelderland, Netherlands