The objective of this study is to pilot the feasibility of MRI and cine imaging in improving pre-operative staging of colon tumors. The specific aims of this pilot study are to establish an optimized scanning protocol and provide preliminary…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patients will undergo an additional MRI with various sequences and cine imaging
(cineMRI and cineCT) prior to surgery.
Main study parameters/endpoints:
The main study parameters and endpoints include:
- Sensitivity and specificity of different MRI sequences in diagnosing T4
disease compared to the gold standard of histological examination.
Secondary outcome
- Sensitivity and specificity of cineMR and cineCT in diagnosing T4 disease
compared to the gold standard of histological examination.
- Sensitivity and specificity of different MRI sequences, including
diffusion-weighted imaging, in diagnosing N2 disease compared to the gold
standard of histological examination.
- The number of discrepancies between the clinical staging of T3/T4 disease
using dedicated diffusion-weighted MRI and the operative and histological
findings.
Background summary
Clinical staging of colon tumors is increasingly important, especially when
considering neo-adjuvant therapy for patients with high-risk tumors (T4 or N2
disease). The current standard work-up using CT and endoscopy is highly
inaccurate, with 40% of pathological T4 tumors not being correctly staged as T4
before surgery. MRI sequences and cine imaging hold promise for more accurate
staging of colon tumors.
Study objective
The objective of this study is to pilot the feasibility of MRI and cine imaging
in improving pre-operative staging of colon tumors. The specific aims of this
pilot study are to establish an optimized scanning protocol and provide
preliminary diagnostic characteristics that can be used to design a larger
trial.
Study design
This is a prospective cohort study
Study burden and risks
Patients participating in the study will be asked to undergo an additional MRI
scan (with gadolinium-based contrast fluid, brand name: Dotarem, regular
dosage). The estimated scanning time is 40 minutes due to the exploration of
different cine sequences. MRI scans are non-invasive and do not involve harmful
radiation. Additionally, an additional cineCT scan will be performed with an
estimated scanning time of 10 minutes, with iodine contrast material (Iomeron
300, regular dosage). The maximum additional radiation exposure with cineCT is
with contrast is 8.4 mSv. This radiation dose falls within the range of 1
diagnostic CT scan routinely performed in the diagnostic workup of this patient
group. The additional risk associated with this radiation dose is negligible
for patients who receive multiple CT scans during diagnostic workup,
perioperative care, and long-term follow-up for colon carcinoma. There is no
direct benefit to participation in the study. However, there is a very small
chance that the additional scans may reveal an incidental diagnosis relevant to
the patient's health. Patients who do not wish to be informed about such a
diagnosis cannot participate in the study.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
- Patients with colon carcinoma and 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT06216743 |
| CCMO | NL84414.091.24 |