Intestinal NeoplasmsNCT03659357
Study of Small Bowel Tumor With Dual-phase Enhanced Computed Tomography (CTE) and Magnetic Resonance Enterography (MRE)
An observational study of Intestinal Neoplasms, run by Tongji Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intestinal Neoplasms
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 30 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the detailed description
The investigators will conduct a 36-month clinical trial, the specific process is as follows:
- Incorporate patients with the above criteria, communicate with the participants to make informed consent and sign informed consent;
- 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;
- 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;
- 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;
- 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;
- 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.
- Conditions
- Intestinal Neoplasms
- Medical subject headings
- Intestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A-first CTE examination | Not described | |
| B-first MRE examination | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the size in centimeters
the size of the small bowel tumor
Measured: 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
the volume of the small bowel tumor
Measured: through study completion, an average of 3 years
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.
Measured: through study completion, an average of 3 years
intensity of the neoplasms measured in the CTE in Hu
the intensity of the small bowel tumor measured in the CTE
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start1 Sep 2018
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yaqi Shen, doctor, Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659357
- Sponsor's protocol ID
- TJ-IRB20180508
- Status last verified
- Sep 2019
- First submitted
- 19 Aug 2018
- Last updated
- 15 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03659357
- Acronym / sponsor ID
- TJ-IRB20180508
- Conditions
- Intestinal Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 6 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Incorporate patients with the above criteria, communicate with the participants to make informed consent and sign informed consent;
- 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;
- 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;
- 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;
- 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;
- 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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A-first CTE examination | – | – |
| B-first MRE examination | – | – |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
volume in cm^3
Time frame: through study completion, an average of 3 years
intensity of the neoplasms measured in the MRE
Time frame: through study completion, an average of 3 years
intensity of the neoplasms measured in the CTE in Hu
Time frame: through study completion, an average of 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaqi Shen, doctor study chair
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intestinal Neoplasms, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the size in centimeters (time frame: through study completion, an average of 3 years, the size of the small bowel tumor will be reported.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019; AzTrials last refreshed its copy on 3 Nov 2026.