Bladder CancerNCT06005116
[68Ga] NOTA-SGC8 in the Staging of Bladder Cancer
A study testing [68Ga]-NOTA-SGC8 in people with Bladder Cancer, run by RenJi Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to test the imaging and diagnostic ability of [68Ga]-NOTA-SGC8 PET/MR in bladder cancer patients with different stages. The main questions it aims to answer are: Tumor specific lighting ability of [68Ga]-NOTA-SGC8 in bladder cancer patients with different stages. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- [68Ga]-NOTA-SGC8
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2023to 31 Dec 2024
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with newly diagnosed or previously diagnosed bladder tumors.
- At least one cystoscopy was performed within one month prior to enrollment, and the clinical diagnosis of bladder tumor was present.
- Age > 18 years, < 80 years
- Patients voluntarily participate and sign informed consent and are willing and able to follow protocol requirements.
Who cannot join
- Pregnancy, lactation, severe liver and kidney insufficiency and children;
- Participants who are allergic to the experimental drug, have an allergic disposition, or are allergic to multiple drugs.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, Shanghai Municipality, 200127
Haige Chen, 13801796126, kirbyhaige@aliyun.com
Haige Chen
About this study
Official title: Exploratory Study on the Effectiveness of Gallium [68Ga] NOTA-SGC8 Injection in the Staging of Bladder Cancer
The goal of this clinical trial is to test the imaging and diagnostic ability of [68Ga]-NOTA-SGC8 PET/MR in bladder cancer patients with different stages. The main questions it aims to answer are:
- Tumor specific lighting ability of [68Ga]-NOTA-SGC8 in bladder cancer patients with different stages.
- The safety of [68Ga]-NOTA-SGC8. Participants will be irrigated with [68Ga]-NOTA-SGC8 into the bladder for tumor imaging under PET/MR. The imaging performance of [68Ga]-NOTA-SGC8 on different stages of bladder tumors will be systematically evaluated by combining with pathological sections of patients. Urine accumulation and radioactivity distribution of [68Ga]-NOTA-SGC8 will be measured. The adverse events will be recorded.
Read the detailed description
Participants will be irrigated with [68Ga]-NOTA-SGC8 intravesically, with 0.05mCi/kg per person per time according to body weight, no more than 5mCi. The participants will be instructed to urinate cleanly before irrigation, and then irrigated [68Ga]-NOTA-SGC8 into the bladder via catheter for 30 minutes to make full contact between the injection and tumor. After 30 minutes, the injection will be withdrawn and 300ml normal saline will be injected into the bladder to maintain the shape of the bladder.
To evaluate the efficacy of [68Ga]-NOTA-SGC8 in imaging bladder tumors, the following indexes will be measured: specific imaging of the tumor area; specific imaging of its target PTK7 receptor protein; distribution in major organs; PET/MR imaging after administration; the absorbed dose of internal radiation based on the reference human hormone model using OLINDA software.
Tumor tissues of patients will be collected, and pathological sections of relevant patients will be analyzed after surgery. Immunohistochemistry will be used to verify the expression of PTK7 receptor in corresponding tumors. The association between PTK7 receptor protein and tumor malignancy, invasion, and stage will be evaluated by molecular imaging results.
All adverse events will be recorded within 24 hours after the administration of [68Ga]-NOTA-SGC8. Serious adverse events will be recorded for all subjects within 24 hours to 5 days after intravesical infusion. Blood and urine samples will be collected and the concentration of 68Ga-NOTA-SGC8 in the blood and urine will be analyzed.
- Conditions
- Bladder Cancer
- Being tested
- [68Ga]-NOTA-SGC8
- Keywords
- Bladder Cancer, [68Ga]-NOTA-SGC8, PET/MR, Bladder Irrigation
- 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.
[68Ga]-NOTA-SGC8Radiation
Participants will be irrigated with [68Ga]-NOTA-SGC8 intravesically, with 0.05mCi/kg per person per time according to body weight, no more than 5mCi. The participants will be instructed to urinate cleanly before irrigation, and then irrigated [68Ga]-NOTA-SGC8 into the bladder via catheter for 30 minutes to make full contact between the injection and tumor. After 30 minutes, the injection will be withdrawn and 300ml normal saline will be injected into the bladder to maintain the shape of the bladder.
| Study group | Role | What they receive |
|---|---|---|
| Bladder Cancer Patients | Experimental | Not described Receives: Radiation: [68Ga]-NOTA-SGC8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor specific lighting ability of [68Ga]-NOTA-SGC8
Number of patients whose tumors are lightened under PET/MR with [68Ga]-NOTA-SGC8
Measured: 2 year
Incidence of treatment-related adverse events of [68Ga]-NOTA-SGC8
Adverse events within 24 hours of intravesical irrigation; Serious adverse events within 5 days of intravesical irrigation
Measured: 2 year
Secondary outcomes (2)
Staging ability of [68Ga]-NOTA-SGC8
Accurate staging ability of [68Ga]-NOTA-SGC8 for bladder tumors
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 posted22 Aug 2023
- Study start15 Sep 2023 (estimated)
- Primary completion31 Dec 2023 (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 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
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005116
- Sponsor's protocol ID
- IIT-2022-0239
- Status last verified
- Aug 2023
- First submitted
- 29 Apr 2023
- Last updated
- 22 Aug 2023
- Results posted
- 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 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on the Effectiveness of Gallium [68Ga] NOTA-SGC8 Injection in the Staging of Bladder Cancer
- ClinicalTrials.gov ID
- NCT06005116
- Acronym / sponsor ID
- IIT-2022-0239
- Conditions
- Bladder Cancer
- Keywords
- Bladder Cancer, [68Ga]-NOTA-SGC8, PET/MR, Bladder Irrigation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 15 Sep 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Aug 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.
The goal of this clinical trial is to test the imaging and diagnostic ability of [68Ga]-NOTA-SGC8 PET/MR in bladder cancer patients with different stages. The main questions it aims to answer are:
- Tumor specific lighting ability of [68Ga]-NOTA-SGC8 in bladder cancer patients with different stages.
- The safety of [68Ga]-NOTA-SGC8. Participants will be irrigated with [68Ga]-NOTA-SGC8 into the bladder for tumor imaging under PET/MR. The imaging performance of [68Ga]-NOTA-SGC8 on different stages of bladder tumors will be systematically evaluated by combining with pathological sections of patients. Urine accumulation and radioactivity distribution of [68Ga]-NOTA-SGC8 will be measured. The adverse events will be recorded.
Detailed description
Participants will be irrigated with [68Ga]-NOTA-SGC8 intravesically, with 0.05mCi/kg per person per time according to body weight, no more than 5mCi. The participants will be instructed to urinate cleanly before irrigation, and then irrigated [68Ga]-NOTA-SGC8 into the bladder via catheter for 30 minutes to make full contact between the injection and tumor. After 30 minutes, the injection will be withdrawn and 300ml normal saline will be injected into the bladder to maintain the shape of the bladder.
To evaluate the efficacy of [68Ga]-NOTA-SGC8 in imaging bladder tumors, the following indexes will be measured: specific imaging of the tumor area; specific imaging of its target PTK7 receptor protein; distribution in major organs; PET/MR imaging after administration; the absorbed dose of internal radiation based on the reference human hormone model using OLINDA software.
Tumor tissues of patients will be collected, and pathological sections of relevant patients will be analyzed after surgery. Immunohistochemistry will be used to verify the expression of PTK7 receptor in corresponding tumors. The association between PTK7 receptor protein and tumor malignancy, invasion, and stage will be evaluated by molecular imaging results.
All adverse events will be recorded within 24 hours after the administration of [68Ga]-NOTA-SGC8. Serious adverse events will be recorded for all subjects within 24 hours to 5 days after intravesical infusion. Blood and urine samples will be collected and the concentration of 68Ga-NOTA-SGC8 in the blood and urine will be analyzed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bladder Cancer Patients | Experimental | Radiation: [68Ga]-NOTA-SGC8 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with newly diagnosed or previously diagnosed bladder tumors.
- At least one cystoscopy was performed within one month prior to enrollment, and the clinical diagnosis of bladder tumor was present.
- Age > 18 years, < 80 years
- Patients voluntarily participate and sign informed consent and are willing and able to follow protocol requirements.
Key exclusion criteria (2 listed)
- Pregnancy, lactation, severe liver and kidney insufficiency and children;
- Participants who are allergic to the experimental drug, have an allergic disposition, or are allergic 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 |
|---|---|---|
| [68Ga]-NOTA-SGC8Participants will be irrigated with [68Ga]-NOTA-SGC8 intravesically, with 0.05mCi/kg per person per time according to body weight, no more than 5mCi. The participants will be instructed to urinate cleanly before irrigation, and then irrigated [68Ga]-NOTA-SGC8 into the bladder via catheter for 30 minutes to make full contact between the injection and tumor. After 30 minutes, the injection will be withdrawn and 300ml normal saline will be injected into the bladder to maintain the shape of the bladder. | Radiation | Bladder Cancer Patients |
Primary outcome
Tumor specific lighting ability of [68Ga]-NOTA-SGC8
Time frame: 2 year
Number of patients whose tumors are lightened under PET/MR with [68Ga]-NOTA-SGC8
Incidence of treatment-related adverse events of [68Ga]-NOTA-SGC8
Time frame: 2 year
Adverse events within 24 hours of intravesical irrigation; Serious adverse events within 5 days of intravesical irrigation
2 secondary outcomes
Staging ability of [68Ga]-NOTA-SGC8
Time frame: 2 year
The expression of PTK7 in bladder tumor tissues
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- 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. 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?
A study testing [68Ga]-NOTA-SGC8 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: status not confirmed, as of the sponsor's last update on 22 Aug 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 Haige Chen (13801796126, kirbyhaige@aliyun.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 [68Ga]-NOTA-SGC8 (time frame: 2 year). The study lists 2 primary outcomes in all. 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 22 Aug 2023.