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

Intestinal Neoplasms Clinical Trial

Official title: A Prospective Comparison of Diagnostic Efficacy and Radiomics Study in the Diagnosis and Therapeutic Efficacy Evaluation of Small Bowel Tumor With Dual-phase Enhanced Computed Tomography (CTE) and Magnetic Resonance Enterography (MRE)

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Intestinal Neoplasms

• NCT number: NCT03659357
• Study type: Observational
• Source: Tongji Hospital
• Status: Enrolling by invitation
• Start date: September 1, 2018
• Completion date: September 30, 2021