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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06216743
Acronym
PRE-MISTIC
Enrollment
15
Registered
2024-01-22
Start date
2025-01-01
Completion date
2025-12-31
Last updated
2024-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

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.

Interventions

DIAGNOSTIC_TESTMRI and CT

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

Sponsors

Radboud University Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

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.

Design outcomes

Primary

MeasureTime frame
Sensitivity and specificity of different MRI sequences to diagnose T4 colon carcinoma.6 weeks

Secondary

MeasureTime frame
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 tumors6 weeks

Countries

Netherlands

Contacts

Primary ContactRichard ten Broek, MD, PhD
Richard.tenbroek@radboudumc.nl+31611469957

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026