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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03659357
• Other study ID #: TJ-IRB20180508
• Status: Enrolling by invitation
• Start date: September 1, 2018
• Est. completion date: September 30, 2021

Study information

• Verified date: September 2019
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2020
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Intestinal Neoplasms

Locations

Country	Name	City	State
China	Yaqi Shen	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the size in centimeters	the size of the small bowel tumor	through study completion, an average of 3 years, the size of the small bowel tumor will be reported.
Secondary	volume in cm^3	the volume of the small bowel tumor	through study completion, an average of 3 years
Secondary	intensity of the neoplasms measured in the MRE	the intensity of the small bowel tumor measured in the MRE, and it is graded into low, moderate and high.	through study completion, an average of 3 years
Secondary	intensity of the neoplasms measured in the CTE in Hu	the intensity of the small bowel tumor measured in the CTE	through study completion, an average of 3 years