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

NCT03659357 | Unknown

• 1 other identifier: TJ-IRB20180508
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Intestinal Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• volume in cm^3

  through study completion, an average of 3 years

• intensity of the neoplasms measured in the MRE

  through study completion, an average of 3 years

• intensity of the neoplasms measured in the CTE in Hu

  through study completion, an average of 3 years

Study Arms (2)

A-first CTE examination

B-first MRE examination

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

consecutive patients who were suspected of having small bowel tumors on the basis of clinical findings and who were previously diagnosed with small bowel tumors underwent CT and MR enterography.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Yaqi Shen

Wuhan, Hubei, 027, China

Location

MeSH Terms

Conditions

Intestinal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases

Study Officials

• Yaqi Shen, doctor

  Tongji Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2018
• First Posted: September 6, 2018
• Study Start: September 1, 2018
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2021
• Last Updated: October 15, 2019

Record last verified: 2019-09

Locations

CN (1)