Colon CancerPRE-MISTICNCT06216743
PRE- MISTIC: MRI and Cine Imaging to Improve Staging of Tumors in the Colon
A study testing MRI and CT in people with Colon Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- MRI and CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, 6500HB
About this study
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
- Being tested
- MRI and CT
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI and CTDiagnostic test
Patients will undergo an additional MRI, cineMRI and CineCT cscan.
| Study group | Role | What they receive |
|---|---|---|
| Imaging cohort | Experimental | Patients participating in pilot study who will receive an additional MRI-scan, cineMRI and cineCT scan. Receives: Diagnostic Test: MRI and CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of different MRI sequences to diagnose T4 colon carcinoma.
Measured: 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.
Measured: 6 weeks
Establishing an MRI Protocol that is optimized for the clinical staging of colon tumors
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216743
- Sponsor's protocol ID
- 84414
- Acronym
- PRE-MISTIC
- Status last verified
- Jan 2024
- First submitted
- 11 Jan 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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 36657089Nerad 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 27490941Brouwer 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 29739638van 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
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRE- MISTIC: MRI and Cine Imaging to Improve Staging of Tumors in the Colon
- ClinicalTrials.gov ID
- NCT06216743
- Acronym / sponsor ID
- PRE-MISTIC / 84414
- Conditions
- Colon Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging cohort | Experimental | Diagnostic Test: MRI and CTPatients participating in pilot study who will receive an additional MRI-scan, cineMRI and cineCT scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI and CTPatients will undergo an additional MRI, cineMRI and CineCT cscan. | Diagnostic test | Imaging cohort |
Primary outcome
Sensitivity and specificity of different MRI sequences to diagnose T4 colon carcinoma.
Time frame: 6 weeks
2 secondary outcomes
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
Establishing an MRI Protocol that is optimized for the clinical staging of colon tumors
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Background: PubMed 36657089Morton 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.
- Background: PubMed 27490941Nerad 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.
- Background: PubMed 29739638Brouwer 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.
- Background: PubMed 29946174van 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI and CT in people with Colon Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard ten Broek, MD, PhD (+31611469957, Richard.tenbroek@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of different MRI sequences to diagnose T4 colon carcinoma. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06216743, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.