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Not yet recruitingNCT06216743PRE-MISTICUpdated Dec 31, 2024

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

An interventional study of MRI and CT in Colon Cancer, sponsored by Radboud University Medical Center. Not yet recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-31.

Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Colon Cancer

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03

In context

Colonic Neoplasms

1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.

This study's planned enrollment of 15 is below the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Imaging cohort

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

    Diagnostic Test: MRI and CT

Interventions

  • Diagnostic testMRI and CT

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

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What researchers measure

Primary outcomes

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

    Time frame: 6 weeks

Secondary outcomes

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

    Time frame: 6 weeks

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

    Time frame: 6 weeks

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Study locations

1 site
  • Radboud University Nijmegen Medical Center
    Nijmegen, Gelderland 6500HB, Netherlands
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References and documents

Publications

  • 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. PubMed 36657089 ↗
  • 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. PubMed 27490941 ↗
  • 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. PubMed 29739638 ↗
  • 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. PubMed 29946174 ↗

Individual participant data

Plan to share: Yes

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06216743
Lead sponsor
Radboud University Medical Center
Responsible party
Sponsor
First posted
Jan 22, 2024
Start date
Jan 1, 2025 (estimated)
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Dec 31, 2024

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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