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

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ClinicalTrials.gov Identifier: NCT03659357
Recruitment Status : Recruiting
First Posted : September 6, 2018
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Intestinal Neoplasms

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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
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)
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
A-first CTE examination
B-first MRE examination



Primary Outcome Measures :
  1. the size in centimeters [ Time Frame: 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 :
  1. volume in cm^3 [ Time Frame: through study completion, an average of 3 years ]
    the volume of the small bowel tumor

  2. intensity of the neoplasms measured in the MRE [ Time Frame: 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.

  3. intensity of the neoplasms measured in the CTE in Hu [ Time Frame: through study completion, an average of 3 years ]
    the intensity of the small bowel tumor measured in the CTE



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03659357


Contacts
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Contact: Yaqi Shen, doctor 0086-13871000123 yqshen@hust.edu.cn

Locations
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China, Hubei
Yaqi Shen Recruiting
Wuhan, Hubei, China, 027
Contact: Yaqi Shen, doctor    13871000123    yqshen@hust.edu.cn   
Sponsors and Collaborators
Tongji Hospital
Investigators
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Study Chair: Yaqi Shen, doctor Tongji Hospital

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Responsible Party: Tongji Hospital
ClinicalTrials.gov Identifier: NCT03659357     History of Changes
Other Study ID Numbers: TJ-IRB20180508
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases