Study of Small Bowel Tumor With Dual-phase Enhanced Computed Tomography (CTE) and Magnetic Resonance Enterography (MRE)

• Conditions: Intestinal Neoplasms

• Registration Number: NCT03659357
• Lead Sponsor: Tongji Hospital

Brief Summary

Purpose: To compare the accuracies of computed tomographic (CT) enterography and magnetic resonance (MR) enterography for the detection and radiomics characterization of small-bowel tumors (including gastrointestinal stromal tumors, adenomas and lymphomas, etc); Hypothesis: MR enterography was noninferior to CT enterography for the diagnosis and evaluation of small bowel tumors in generally well-distended small bowel.

Detailed Description

The investigators will conduct a 36-month clinical trial, the specific process is as follows:

1. Incorporate patients with the above criteria, communicate with the participants to make informed consent and sign informed consent;

2. It is recommended that the attending physician issue the corresponding MRE checklist and the CTE checklist and make an appointment to check the same day to remind the patient to perform the corresponding bowel preparation work in advance, and perform renal function tests within 3 days before the examination;

3. The enrolled patients were measured for height and weight, and the BMI was calculated. CTE and MRE were performed according to the results of balanced randomization. The MRE was performed on a 3.0T MRI scanner; the CTE examination was performed on a 320-row CT scanner, and the iodine-containing contrast agent was administered according to the patient's height and weight and GFR;

4. Both examinations require an empty stomach preparation (more than 4 hours), and oral (1500ml) 2.5% mannitol aqueous solution before the examination to ensure intestinal filling, subcutaneous indwelling needle preparation, in order to save patient examination time, so the two examinations are completed within 6 hours, before the second inspection, you need to add 150-300ml of 2.5% mannitol aqueous solution;

5. The images obtained were evaluated by two imaging physicians for lesions, numbers, size changes, density/signal values, and peripheral tissue lesions obtained by the two methods;

6. After the patient has obtained a definitive diagnosis according to the routine medical procedure, the above imaging diagnosis results are compared with the confirmed diagnosis results.

Study Timeline

• Study First Submitted: 2018-08-19
• Study Start: 2018-09-01
• Study First Submitted QC: 2018-09-03
• Study First Posted: 2018-09-06
• Status Verified: 2019-09
• Last Update Submitted: 2019-10-11
• Last Update Posted: 2019-10-15
• Primary Completion: 2020-09-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients with clinical suspicion of small intestinal neoplasms and prescribed CTE and/or MRE examinations;
• Age/sex: unlimited;
• Patients with no severe heart, liver, kidney insufficiency;
• Patients who voluntarily participate in clinical trials and sign written informed consent.

Exclusion Criteria

• patients with heart and liver insufficiency;
• patients with pacemakers installed and which materials are unknown, and patients with metal implants in the body, and nerve stimulators;
• patients who are allergic to iodine and intestinal contrast agents;
• pregnant women, patients with acute or chronic renal failure and hemodynamic instability;
• patients unable to tolerate adequate breath holding for complete CT or MR examination;
• patients who can not maintain compliance and cannot strictly implement the plan.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the size in centimeters	through study completion, an average of 3 years, the size of the small bowel tumor will be reported.	the size of the small bowel tumor

Secondary Outcome Measures

Name	Time	Method
volume in cm^3	through study completion, an average of 3 years	the volume of the small bowel tumor
intensity of the neoplasms measured in the MRE	through study completion, an average of 3 years	the intensity of the small bowel tumor measured in the MRE, and it is graded into low, moderate and high.
intensity of the neoplasms measured in the CTE in Hu	through study completion, an average of 3 years	the intensity of the small bowel tumor measured in the CTE

Trial Locations

Locations (1)

Yaqi Shen; 🇨🇳 Wuhan, Hubei, China