Gastric CancerNCT06735105
Study on the Value of Three DWI Scanning Sequences in Staging of Gastric Cancer
A study testing Scanning parameter in people with Gastric Cancer, run by Yunnan Cancer Hospital at 1 site in China.
Trial summary
Accurate staging is critical for effective gastric cancer treatment planning. Conventional DWI (C-DWI) has limitations in image quality due to magnetic field inhomogeneity, which hampers precise T staging. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Scanning parameter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteChina
- Study dates
- 23 Dec 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient was diagnosed with gastric cancer by pathological biopsy
- No biopsy was taken within 1 week before MR Examination to rule out the effect of bleeding on the image
- No contraindications for MRI examination; And exclude serious heart, liver, kidney, cerebrovascular diseases.
Who cannot join
- The image quality cannot meet the diagnostic criteria;
- Patients could not tolerate MRI examination, resulting in incomplete MR-related sequence image data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Yunnan Cancer Hospital
Kunming
Zhang Guojun, Professor, 0871-68173640
About this study
Official title: Comparative Study on the Value of Three DWI Scan Sequences of 3.0T Magnetic Resonance in Staging of Gastric Cancer
Accurate staging is critical for effective gastric cancer treatment planning. Conventional DWI (C-DWI) has limitations in image quality due to magnetic field inhomogeneity, which hampers precise T staging.
This study aims to compare the image quality and T staging accuracy of C-DWI, TSE-DWI, and ZOOMit-DWI (Z-DWI) sequences in MRI examinations of gastric cancer patients.
A prospective study plan to enroll 72 gastric cancer patients undergoing preoperative MRI with C-DWI, TSE-DWI, and Z-DWI sequences using a 3.0 T scanner. Quantitative metrics (ADC, SNR, CNR) and image quality were evaluated. T staging accuracy was assessed by comparing MRI results with postoperative pathological staging using ROC analysis.
- Conditions
- Gastric Cancer
- Being tested
- Scanning parameter
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scanning parameterDiagnostic test
Based on abdominal scanning, TSE-DWI,ZOOMIT DWI and EPI-DWI scans were performed, and the study was divided into two steps according to the nanomotion criteria. The first step was self-controlled, which was divided into experimental group and control group. The experimental group included TSE-DWI,ZOOMit DWI, and the control group included EPI-DWI. Then the image quality was evaluated by subjective and objective evaluation indexes. In the second step, the three DWI stages were performed separately by four diagnosticians, with an interval of 1 month, and statistical analysis was performed at the end.
| Study group | Role | What they receive |
|---|---|---|
| SS-EPI-DWI T-stage of gastric cancer | No intervention | Not described |
| TSE-DWI T-stage of gastric cancer | Other | Not described Receives: Diagnostic Test: Scanning parameter |
| ZOOM-DWI T-stage of gastric cancer | Other | Not described Receives: Diagnostic Test: Scanning parameter |
What is being measured
The primary outcome is the main question the study is designed to answer.
T staging of gastric cancer
Study on the value of three DWI scanning sequences in T staging of gastric cancer
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start23 Dec 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yunnan Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lianhua Ye, Study director, Ethics Committee of Yunnan Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735105
- Sponsor's protocol ID
- KYLX2023-167
- Status last verified
- Dec 2024
- First submitted
- 27 Nov 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on the Value of Three DWI Scan Sequences of 3.0T Magnetic Resonance in Staging of Gastric Cancer
- ClinicalTrials.gov ID
- NCT06735105
- Acronym / sponsor ID
- KYLX2023-167
- Conditions
- Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- Yunnan Cancer HospitalUniversity, hospital or other
- Study start
- 23 Dec 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 Dec 2024 (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.
Accurate staging is critical for effective gastric cancer treatment planning. Conventional DWI (C-DWI) has limitations in image quality due to magnetic field inhomogeneity, which hampers precise T staging.
This study aims to compare the image quality and T staging accuracy of C-DWI, TSE-DWI, and ZOOMit-DWI (Z-DWI) sequences in MRI examinations of gastric cancer patients.
A prospective study plan to enroll 72 gastric cancer patients undergoing preoperative MRI with C-DWI, TSE-DWI, and Z-DWI sequences using a 3.0 T scanner. Quantitative metrics (ADC, SNR, CNR) and image quality were evaluated. T staging accuracy was assessed by comparing MRI results with postoperative pathological staging using ROC analysis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SS-EPI-DWI T-stage of gastric cancer | No intervention | – |
| TSE-DWI T-stage of gastric cancer | Other | Diagnostic Test: Scanning parameter |
| ZOOM-DWI T-stage of gastric cancer | Other | Diagnostic Test: Scanning parameter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient was diagnosed with gastric cancer by pathological biopsy
- No biopsy was taken within 1 week before MR Examination to rule out the effect of bleeding on the image
- No contraindications for MRI examination; And exclude serious heart, liver, kidney, cerebrovascular diseases.
Key exclusion criteria (2 listed)
- The image quality cannot meet the diagnostic criteria;
- Patients could not tolerate MRI examination, resulting in incomplete MR-related sequence image data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scanning parameterBased on abdominal scanning, TSE-DWI,ZOOMIT DWI and EPI-DWI scans were performed, and the study was divided into two steps according to the nanomotion criteria. The first step was self-controlled, which was divided into experimental group and control group. The experimental group included TSE-DWI,ZOOMit DWI, and the control group included EPI-DWI. Then the image quality was evaluated by subjective and objective evaluation indexes. In the second step, the three DWI stages were performed separately by four diagnosticians, with an interval of 1 month, and statistical analysis was performed at the end. | Diagnostic test | TSE-DWI T-stage of gastric cancer, ZOOM-DWI T-stage of gastric cancer |
Primary outcome
T staging of gastric cancer
Time frame: one year
Study on the value of three DWI scanning sequences in T staging of gastric cancer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Lianhua Ye study director
Ethics Committee of Yunnan Provincial Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scanning parameter in people with Gastric Cancer, run by Yunnan Cancer 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 16 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Yanli, master (18987958050, lyl2241@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T staging of gastric cancer (time frame: one year). 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 16 Dec 2024; AzTrials last refreshed its copy on 31 Oct 2026.