Bladder TumorNCT06033040
Medical Imaging in Bladder Tumors by MRI
An observational study of Bladder Tumor and Magnetic Resonance Imaging, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
This study prospectively included 178 patients with bladder neoplastic lesions who planned to undergo surgery (with or without preoperative neoadjuvant chemotherapy). Inclusion criteria: Patients with pathologically confirmed bladder cancer after radical or partial cystectomy or TURBT (< 2 weeks between surgical… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bladder Tumor, Magnetic Resonance Imaging
- What is being tested?
- MRI
- How many people
- 178 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2023to 31 Dec 2025
- How long will I take part?
- 1 Month
- 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: Patients with bladder neoplasm planned to undergo surgery
Who may be able to join
- Clinical diagnosis of bladder neoplasm
- Must undergo radical or partial cystectomy or TURBT surgery within 2 weeks between surgical resection and imaging
Who cannot join
- A history of pelvic radiotherapy or chemotherapy;
- Lack of pathological findings or no surgery;
- The interval between surgical resection and imaging examination > 2 weeks;
- Poor image quality due to poor coordination or motion artifacts;
- MRI scan contraindications
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Yuan Luo, 18816791193, luoy289@mail2.sysu.edu.cn
About this study
Official title: Clinical Study on the Diagnostic and Predictive Value of MRI Multifunctional Imaging in Bladder Tumors
This study prospectively included 178 patients with bladder neoplastic lesions who planned to undergo surgery (with or without preoperative neoadjuvant chemotherapy). Inclusion criteria: Patients with pathologically confirmed bladder cancer after radical or partial cystectomy or TURBT (< 2 weeks between surgical resection and imaging). Exclusion criteria: 1) Prior history of chemotherapy and/or radiotherapy; 2) No surgical resection; 3) The interval between surgical resection and imaging examination is > 2 weeks; 4) Obvious artifacts; 5)MRI scan contraindications. All subjects underwent pelvic MRI. Data was collected using a Siemens VIDA 3TMR scanner (Siemens Healthcare, Erlangen, Germany). All subjects underwent standardized scanning protocols. The obtained images are post-processed and the experimental results are analyzed statistically.
- Conditions
- Bladder Tumor, Magnetic Resonance Imaging
- Being tested
- MRI
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
Functional sequence imaging (MDME, IVIM) sequences were added to the routine MRI scan of patients with bladder tumor
What is being measured
The primary outcome is the main question the study is designed to answer.
quantitative parameters by MRI
quantitative parameters by functional MRI
Measured: From the time the participants completed the MRI scan to the post-processing of the resulting images,assessed up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start15 Aug 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder TumorStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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 only
- Time perspective
- Prospective
- Enrolment
- 178 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033040
- Sponsor's protocol ID
- SYSKY-2023-549-01
- Status last verified
- Sep 2023
- First submitted
- 27 Jul 2023
- Last updated
- 13 Sep 2023
- 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 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Diagnostic and Predictive Value of MRI Multifunctional Imaging in Bladder Tumors
- ClinicalTrials.gov ID
- NCT06033040
- Acronym / sponsor ID
- SYSKY-2023-549-01
- Conditions
- Bladder Tumor, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Sep 2023 (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.
This study prospectively included 178 patients with bladder neoplastic lesions who planned to undergo surgery (with or without preoperative neoadjuvant chemotherapy). Inclusion criteria: Patients with pathologically confirmed bladder cancer after radical or partial cystectomy or TURBT (< 2 weeks between surgical resection and imaging). Exclusion criteria: 1) Prior history of chemotherapy and/or radiotherapy; 2) No surgical resection; 3) The interval between surgical resection and imaging examination is > 2 weeks; 4) Obvious artifacts; 5)MRI scan contraindications. All subjects underwent pelvic MRI. Data was collected using a Siemens VIDA 3TMR scanner (Siemens Healthcare, Erlangen, Germany). All subjects underwent standardized scanning protocols. The obtained images are post-processed and the experimental results are analyzed statistically.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with bladder neoplasm planned to undergo surgery
Key inclusion criteria (2 listed)
- Clinical diagnosis of bladder neoplasm
- Must undergo radical or partial cystectomy or TURBT surgery within 2 weeks between surgical resection and imaging
Key exclusion criteria (5 listed)
- A history of pelvic radiotherapy or chemotherapy;
- Lack of pathological findings or no surgery;
- The interval between surgical resection and imaging examination > 2 weeks;
- Poor image quality due to poor coordination or motion artifacts;
- MRI scan contraindications
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 |
|---|---|---|
| MRIFunctional sequence imaging (MDME, IVIM) sequences were added to the routine MRI scan of patients with bladder tumor | Other | – |
Primary outcome
quantitative parameters by MRI
Time frame: From the time the participants completed the MRI scan to the post-processing of the resulting images,assessed up to 2 months
quantitative parameters by functional MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
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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.
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 Bladder Tumor and Magnetic Resonance Imaging, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 2 inclusion and 5 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 13 Sep 2023. 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?
Contact Yuan Luo, master (8618816791193, luoy289@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quantitative parameters by MRI (time frame: From the time the participants completed the MRI scan to the post-processing of the resulting images,assessed up to 2 months). 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 13 Sep 2023.