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

Colon Cancer Clinical Trial

— PRE-MISTIC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06216743
• Other study ID #: 84414
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Radboud University Medical Center
• Contact: Richard ten Broek, MD, PhD
• Phone: +31611469957
• Email: Richard.tenbroek[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Diagnostic Test:
• MRI and CT
Patients will undergo an additional MRI, cineMRI and CineCT cscan.

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Center	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of different MRI sequences to diagnose T4 colon carcinoma.		6 weeks
Secondary	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
Secondary	Establishing an MRI Protocol that is optimized for the clinical staging of colon tumors		6 weeks