Bladder CancerNCT06763354
The Efficacy of Gallium[68Ga]NOTA-DNA Multivalent SGC8 Injection for Bladder Tumour Imaging
A study testing Gallium[68Ga]NOTA-DNA Multivalent SGC8 Injection in people with Bladder Cancer, run by RenJi Hospital at 1 site in China.
Trial summary
The study was planned to include patients with bladder tumors attending the Department of Urology, Renji Hospital, Shanghai Jiaotong University School of Medicine, from 09/2024 to 12/2025. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Gallium[68Ga]NOTA-DNA Multivalent SGC8 Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 8 Feb 2025to 31 Dec 2025
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary enrolment with signed informed consent
- Age >18 years, <85 years
- Cystoscopic diagnosis of bladder tumour with imaging and pathology reports not required
- Willingness and ability to follow trial protocol requirements.
Who cannot join
- Pregnancy, breastfeeding, severe hepatic, renal insufficiency and children
- Hypersensitivity to the test drug, allergy or allergy to multiple drugs
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
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Di Jin, 13501840824, rjbladder@163.com
About this study
Official title: An Exploratory Clinical Study of the Efficacy of Gallium[68Ga]NOTA-DNA Multivalent SGC8 Injection for Bladder Tumour Imaging
The study was planned to include patients with bladder tumors attending the Department of Urology, Renji Hospital, Shanghai Jiaotong University School of Medicine, from 09/2024 to 12/2025. Patient demographics will be collected, patients will be monitored for medical history and co-morbidities, co-morbid medications or treatments, vital signs, and cystoscopy will be performed. Patients meeting the inclusion criteria will be included in this study. Patients will receive PET/MR imaging after bladder instillation of [68Ga] NOTA-DNA multivalent SGC8 injection to assess the effectiveness of bladder tumor imaging and to evaluate the safety of [68Ga] NOTA-DNA multivalent SGC8.
The primary study was the ability of gallium [68Ga] NOTA-DNA multivalent SGC8 injection to provide tumor-specific imaging of bladder tumor patients of different genders, with a compliance rate of more than 80% when compared to the gold standard TUR pathology. To study the safety of gallium[68Ga] NOTA-DNA multivalent SGC8 injection; to assess the correlation between gallium[68Ga] NOTA-DNA multivalent SGC8 imaging ability and clinical parameters; to study the ability of gallium [68Ga]NOTA-DNA multivalent SGC8 to differentiate between bladder tumor foci and inflammatory foci; to explore the gallium [68Ga]NOTA- DNA multivalent SGC8 target PTK7 receptor protein expression in bladder tumors and the correlation between tumor differentiation and malignancy.
- Conditions
- Bladder Cancer
- Being tested
- Gallium[68Ga]NOTA-DNA Multivalent SGC8 Injection
- 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.
Gallium[68Ga]NOTA-DNA Multivalent SGC8 InjectionRadiation
On the examination bed, the patient was placed in the lying truncated position, the perineum was disinfected with a towel, and a double-lumen urinary catheter was inserted via the perineum.Inject 50ml saline to clean the bladder once, open the drainage bag to drain.1mci SGC8 was dissolved in 50ml physiological saline. The drainage bag was clamped shut and 50ml of developer was injected into the bladder through the catheter, followed by 10ml of gas or saline (all developer in the ureter was injected into the bladder. The catheter was closed for 1 hour, during which time the patient was placed in the flat position, left lateral position, right lateral position, and supine position changing positions every 15 minutes.After 1 hour, the drainage bag was opened, the bladder was emptied with radioactive fluid, and the urine bag was replaced.
| Study group | Role | What they receive |
|---|---|---|
| Patients with bladder tumors | Experimental | Not described Receives: Radiation: Gallium[68Ga]NOTA-DNA Multivalent SGC8 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor specific lighting ability of Gallium[68Ga]NOTA-DNA Multivalent SGC8
Number of patients whose tumors are lightened under PET/MR with Gallium[68Ga]NOTA-DNA Multivalent SGC8
Measured: 2 year
Secondary outcomes (4)
Safety of Gallium[68Ga]NOTA-DNA Multivalent SGC8
Adverse events within 24 hours of intravesical irrigation; Serious adverse events within 5 days of intravesical irrigation
Measured: 2 Year
Accuracy in clinical parameters of Gallium[68Ga] NOTA-DNA multivalent SGC8
Correlation between gallium[68Ga] NOTA-DNA multivalent SGC8 images and clinical parameters
Measured: 2 Year
Foci-distinguishing ability of Gallium [68Ga]NOTA-DNA multivalent SGC8
The ability of gallium [68Ga]NOTA-DNA multivalent SGC8 to differentiate between bladder tumor foci and inflammatory foci
Measured: 2 Year
The expression of PTK7 in bladder tumor tissues
The expression of [68Ga]-NOTA-SGC8 target PTK7 receptor protein in bladder tumor tissues
Measured: 2 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start8 Feb 2025
- 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 CancerStudies of the same condition, open and under way.
- More trials run by RenJi 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Combination Product
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Peifeng, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763354
- Sponsor's protocol ID
- IIT-2024-0231
- Status last verified
- Jan 2025
- First submitted
- 22 Dec 2024
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of the Efficacy of Gallium[68Ga]NOTA-DNA Multivalent SGC8 Injection for Bladder Tumour Imaging
- ClinicalTrials.gov ID
- NCT06763354
- Acronym / sponsor ID
- IIT-2024-0231
- Conditions
- Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 8 Feb 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Jan 2025 (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.
The study was planned to include patients with bladder tumors attending the Department of Urology, Renji Hospital, Shanghai Jiaotong University School of Medicine, from 09/2024 to 12/2025. Patient demographics will be collected, patients will be monitored for medical history and co-morbidities, co-morbid medications or treatments, vital signs, and cystoscopy will be performed. Patients meeting the inclusion criteria will be included in this study. Patients will receive PET/MR imaging after bladder instillation of [68Ga] NOTA-DNA multivalent SGC8 injection to assess the effectiveness of bladder tumor imaging and to evaluate the safety of [68Ga] NOTA-DNA multivalent SGC8.
The primary study was the ability of gallium [68Ga] NOTA-DNA multivalent SGC8 injection to provide tumor-specific imaging of bladder tumor patients of different genders, with a compliance rate of more than 80% when compared to the gold standard TUR pathology. To study the safety of gallium[68Ga] NOTA-DNA multivalent SGC8 injection; to assess the correlation between gallium[68Ga] NOTA-DNA multivalent SGC8 imaging ability and clinical parameters; to study the ability of gallium [68Ga]NOTA-DNA multivalent SGC8 to differentiate between bladder tumor foci and inflammatory foci; to explore the gallium [68Ga]NOTA- DNA multivalent SGC8 target PTK7 receptor protein expression in bladder tumors and the correlation between tumor differentiation and malignancy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Combination Product
| Arm | Type | Receives |
|---|---|---|
| Patients with bladder tumors | Experimental | Radiation: Gallium[68Ga]NOTA-DNA Multivalent SGC8 Injection |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Voluntary enrolment with signed informed consent
- Age >18 years, <85 years
- Cystoscopic diagnosis of bladder tumour with imaging and pathology reports not required
- Willingness and ability to follow trial protocol requirements.
Key exclusion criteria (2 listed)
- Pregnancy, breastfeeding, severe hepatic, renal insufficiency and children
- Hypersensitivity to the test drug, allergy or allergy to multiple drugs
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 |
|---|---|---|
| Gallium[68Ga]NOTA-DNA Multivalent SGC8 InjectionOn the examination bed, the patient was placed in the lying truncated position, the perineum was disinfected with a towel, and a double-lumen urinary catheter was inserted via the perineum.Inject 50ml saline to clean the bladder once, open the drainage bag to drain.1mci SGC8 was dissolved in 50ml physiological saline. The drainage bag was clamped shut and 50ml of developer was injected into the bladder through the catheter, followed by 10ml of gas or saline (all developer in the ureter was injected into the bladder. The catheter was closed for 1 hour, during which time the patient was placed in the flat position, left lateral position, right lateral position, and supine position changing positions every 15 minutes.After 1 hour, the drainage bag was opened, the bladder was emptied with radioactive fluid, and the urine bag was replaced. | Radiation | Patients with bladder tumors |
Primary outcome
Tumor specific lighting ability of Gallium[68Ga]NOTA-DNA Multivalent SGC8
Time frame: 2 year
Number of patients whose tumors are lightened under PET/MR with Gallium[68Ga]NOTA-DNA Multivalent SGC8
4 secondary outcomes
Safety of Gallium[68Ga]NOTA-DNA Multivalent SGC8
Time frame: 2 Year
Accuracy in clinical parameters of Gallium[68Ga] NOTA-DNA multivalent SGC8
Time frame: 2 Year
Foci-distinguishing ability of Gallium [68Ga]NOTA-DNA multivalent SGC8
Time frame: 2 Year
The expression of PTK7 in bladder tumor tissues
Time frame: 2 Year
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 14 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gallium[68Ga]NOTA-DNA Multivalent SGC8 Injection in people with Bladder Cancer, run by RenJi 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 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 14 Mar 2025. 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 Peifeng Liu (86 13512116782, 2775@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor specific lighting ability of Gallium[68Ga]NOTA-DNA Multivalent SGC8 (time frame: 2 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 14 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.