Bladder Cancer (BC)Phase 2NCT07848854
Trop2-Targeted NIR-II Fluorescent Probe for Identifying Bladder Cancer in Ex Vivo Bladder Samples
A Phase 2 study testing TTP-ICG fluorescent probe in people with Bladder Cancer (BC) and Urothelial Carcinoma (UC), run by Yunnan Cancer Hospital at 1 site in China.
Trial summary
Up to 30% of non-muscle-invasive bladder cancer (NMIBC) lesions may be missed by standard white-light cystoscopy, resulting in high tumor recurrence rate. This is a single-center, single-arm, phase 2 prospective study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bladder Cancer (BC), Urothelial Carcinoma (UC)
- What is being tested?
- TTP-ICG fluorescent probe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 30 Aug 2027
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suspected or confirmed bladder tumor patients who are scheduled to undergo radical cystectomy.
- Able to provide written informed consent and comply with study protocol.
Who cannot join
- Suffering from other invasive malignant tumors.
- With severe comorbidities including congenital malformation, acute active inflammation, cachexia, myocardial infarction or stroke within past 6 months, severe hepatic or renal insufficiency.
- Pregnant or lactating female subjects.
- Participated in another clinical trial within past 30 days.
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, Yunnan, 650118
Guojun Zhang, Doctor of Medicine, 86+18850064298, zhangguojun@kmmu.edu.cn
About this study
Up to 30% of non-muscle-invasive bladder cancer (NMIBC) lesions may be missed by standard white-light cystoscopy, resulting in high tumor recurrence rate. This is a single-center, single-arm, phase 2 prospective study. We apply Trop2-targeted NIR-II fluorescent probe TTP-ICG with rapid incubation to ex vivo bladder specimens from patients undergoing radical cystectomy. Near-infrared fluorescence imaging is performed after short-time incubation and washing. Using histopathology as gold standard, we evaluate the sensitivity, specificity of this imaging system for identifying bladder cancer lesions, and analyze correlation between fluorescence intensity and pathological diagnosis. 30 subjects will be enrolled.
Read the detailed description
> Bladder cancer is one of the most common human malignancies. Approximately 70% of newly diagnosed patients present with non-muscle-invasive bladder cancer (NMIBC). White-light endoscopy, the routine clinical method, misses up to 30% of lesions especially small satellite tumors and flat carcinoma in situ (CIS), contributing to high recurrence up to 70%. Existing alternative endoscopic imaging techniques suffer from high false-positive rates or narrow field-of-view. Trop2 is overexpressed in urothelial bladder carcinoma, and Trop2-targeted antibody-drug conjugate has been FDA-approved for urothelial carcinoma, validating Trop2 as a reliable tumor biomarker.
This phase 2, single-center, single-arm prospective study plans to enroll 30 suspected or confirmed bladder tumor patients scheduled for radical cystectomy. After surgical removal of whole-bladder specimen ex vivo, 50 mL TTP-ICG solution (20 μg/mL) is instilled into the lumen of isolated bladder for 3-minute incubation. After discarding probe solution, the bladder lumen is rinsed 3 times with normal saline. Near-infrared-II fluorescence imaging is performed over the entire inner bladder surface. Lesions highlighted by fluorescence are sampled for histopathological examination. With postoperative histopathology as gold standard, we calculate sensitivity, specificity, false-positive rate, false-negative rate of this imaging system for detecting malignant lesions. Fluorescence intensity of tumor foci and normal bladder mucosa are measured to explore correlation between fluorescence signal and pathological diagnosis. This ex-vivo study provides pre-clinical evidence for future in-vivo application, aiming to reduce missed diagnosis and recurrence of NMIBC.
- Conditions
- Bladder Cancer (BC), Urothelial Carcinoma (UC)
- Being tested
- TTP-ICG fluorescent probe
- Keywords
- Bladder Cancer, TROP2
- Medical subject headings
- Urinary Bladder Neoplasms, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTP-ICG fluorescent probeDrug
After radical cystectomy, 50 mL TTP-ICG solution (20 μg/mL) is instilled into lumen of isolated bladder specimen for 3 minutes incubation. Then probe solution is drained; bladder lumen washed 3 times by normal saline(30 seconds per time). Near-infrared-II fluorescence imaging is performed on inner bladder surface. Fluorescent highlighted lesions are harvested for pathological examination.
| Study group | Role | What they receive |
|---|---|---|
| TTP-ICG ex-vivo rapid incubation fluorescence imaging | Experimental | Not described Receives: Drug: TTP-ICG fluorescent probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Sensitivity of ex-vivo Trop2-targeted NIR-II fluorescence imaging for detecting malignant bladder lesions
Sensitivity of TTP-ICG rapid-incubation NIR-II fluorescence imaging to identify malignant bladder lesions in ex-vivo radical-cystectomy specimens. Histopathology serves as gold-standard reference. Sensitivity = true-positive / (true-positive + false-negative).
Measured: Within 7 days after collection of ex-vivo bladder specimen, after histopathology report available
Diagnostic Specificity of ex-vivo Trop2-targeted NIR-II fluorescence imaging for detecting malignant bladder lesions
Specificity of TTP-ICG rapid-incubation NIR-II fluorescence imaging to identify malignant bladder lesions in ex-vivo radical-cystectomy specimens. Histopathology serves as gold-standard reference. Specificity = true-negative / (true-negative + false-positive)
Measured: Within 7 days after collection of ex-vivo bladder specimen, after histopathology report available
False-Positive Rate of ex-vivo Trop2-targeted NIR-II fluorescence imaging for detecting malignant bladder lesions
False-positive rate of TTP-ICG rapid-incubation NIR-II fluorescence imaging for bladder-cancer lesion detection on ex-vivo specimens, using histopathology as gold standard. False-positive rate = false-positive / (true-negative + false-positive)
Measured: Within 7 days after collection of ex-vivo bladder specimen, after histopathology report available
False-Negative Rate of ex-vivo Trop2-targeted NIR-II fluorescence imaging for detecting malignant bladder lesions
False-negative rate of TTP-ICG rapid-incubation NIR-II fluorescence imaging for bladder-cancer lesion detection on ex-vivo specimens, using histopathology as gold standard. False-negative rate = false-negative / (true-positive + false-negative)
Measured: Within 7 days after collection of ex-vivo bladder specimen, after histopathology report available
Secondary outcomes (1)
Near-infrared-II fluorescence intensity of tumor lesions and normal bladder mucosa
Quantitative NIR-II fluorescence intensity values measured for malignant tumor lesions and normal bladder mucosal epithelium on ex-vivo bladder specimens
Measured: Within 7 days after collection of ex-vivo bladder specimen, after histopathology report available
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Aug 2026
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Cancer (BC)Studies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yunnan Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848854
- Sponsor's protocol ID
- KYLX2026-287
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trop2-Targeted NIR-II Fluorescent Probe for Identifying Bladder Cancer in Ex Vivo Bladder Samples
- ClinicalTrials.gov ID
- NCT07848854
- Acronym / sponsor ID
- KYLX2026-287
- Conditions
- Bladder Cancer (BC), Urothelial Carcinoma (UC)
- Keywords
- Bladder Cancer, TROP2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yunnan Cancer HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 30 Sep 2026 (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.
Up to 30% of non-muscle-invasive bladder cancer (NMIBC) lesions may be missed by standard white-light cystoscopy, resulting in high tumor recurrence rate. This is a single-center, single-arm, phase 2 prospective study. We apply Trop2-targeted NIR-II fluorescent probe TTP-ICG with rapid incubation to ex vivo bladder specimens from patients undergoing radical cystectomy. Near-infrared fluorescence imaging is performed after short-time incubation and washing. Using histopathology as gold standard, we evaluate the sensitivity, specificity of this imaging system for identifying bladder cancer lesions, and analyze correlation between fluorescence intensity and pathological diagnosis. 30 subjects will be enrolled.
Detailed description
> Bladder cancer is one of the most common human malignancies. Approximately 70% of newly diagnosed patients present with non-muscle-invasive bladder cancer (NMIBC). White-light endoscopy, the routine clinical method, misses up to 30% of lesions especially small satellite tumors and flat carcinoma in situ (CIS), contributing to high recurrence up to 70%. Existing alternative endoscopic imaging techniques suffer from high false-positive rates or narrow field-of-view. Trop2 is overexpressed in urothelial bladder carcinoma, and Trop2-targeted antibody-drug conjugate has been FDA-approved for urothelial carcinoma, validating Trop2 as a reliable tumor biomarker.
This phase 2, single-center, single-arm prospective study plans to enroll 30 suspected or confirmed bladder tumor patients scheduled for radical cystectomy. After surgical removal of whole-bladder specimen ex vivo, 50 mL TTP-ICG solution (20 μg/mL) is instilled into the lumen of isolated bladder for 3-minute incubation. After discarding probe solution, the bladder lumen is rinsed 3 times with normal saline. Near-infrared-II fluorescence imaging is performed over the entire inner bladder surface. Lesions highlighted by fluorescence are sampled for histopathological examination. With postoperative histopathology as gold standard, we calculate sensitivity, specificity, false-positive rate, false-negative rate of this imaging system for detecting malignant lesions. Fluorescence intensity of tumor foci and normal bladder mucosa are measured to explore correlation between fluorescence signal and pathological diagnosis. This ex-vivo study provides pre-clinical evidence for future in-vivo application, aiming to reduce missed diagnosis and recurrence of NMIBC.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TTP-ICG ex-vivo rapid incubation fluorescence imaging | Experimental | Drug: TTP-ICG fluorescent probe |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Suspected or confirmed bladder tumor patients who are scheduled to undergo radical cystectomy.
- Able to provide written informed consent and comply with study protocol.
Key exclusion criteria (4 listed)
- Suffering from other invasive malignant tumors.
- With severe comorbidities including congenital malformation, acute active inflammation, cachexia, myocardial infarction or stroke within past 6 months, severe hepatic or renal insufficiency.
- Pregnant or lactating female subjects.
- Participated in another clinical trial within past 30 days.
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 |
|---|---|---|
| TTP-ICG fluorescent probeAfter radical cystectomy, 50 mL TTP-ICG solution (20 μg/mL) is instilled into lumen of isolated bladder specimen for 3 minutes incubation. Then probe solution is drained; bladder lumen washed 3 times by normal saline(30 seconds per time). Near-infrared-II fluorescence imaging is performed on inner bladder surface. Fluorescent highlighted lesions are harvested for pathological examination. | Drug | TTP-ICG ex-vivo rapid incubation fluorescence imaging |
Primary outcome
Diagnostic Sensitivity of ex-vivo Trop2-targeted NIR-II fluorescence imaging for detecting malignant bladder lesions
Time frame: Within 7 days after collection of ex-vivo bladder specimen, after histopathology report available
Sensitivity of TTP-ICG rapid-incubation NIR-II fluorescence imaging to identify malignant bladder lesions in ex-vivo radical-cystectomy specimens. Histopathology serves as gold-standard reference. Sensitivity = true-positive / (true-positive + false-negative).
Diagnostic Specificity of ex-vivo Trop2-targeted NIR-II fluorescence imaging for detecting malignant bladder lesions
Time frame: Within 7 days after collection of ex-vivo bladder specimen, after histopathology report available
Specificity of TTP-ICG rapid-incubation NIR-II fluorescence imaging to identify malignant bladder lesions in ex-vivo radical-cystectomy specimens. Histopathology serves as gold-standard reference. Specificity = true-negative / (true-negative + false-positive)
False-Positive Rate of ex-vivo Trop2-targeted NIR-II fluorescence imaging for detecting malignant bladder lesions
Time frame: Within 7 days after collection of ex-vivo bladder specimen, after histopathology report available
False-positive rate of TTP-ICG rapid-incubation NIR-II fluorescence imaging for bladder-cancer lesion detection on ex-vivo specimens, using histopathology as gold standard. False-positive rate = false-positive / (true-negative + false-positive)
False-Negative Rate of ex-vivo Trop2-targeted NIR-II fluorescence imaging for detecting malignant bladder lesions
Time frame: Within 7 days after collection of ex-vivo bladder specimen, after histopathology report available
False-negative rate of TTP-ICG rapid-incubation NIR-II fluorescence imaging for bladder-cancer lesion detection on ex-vivo specimens, using histopathology as gold standard. False-negative rate = false-negative / (true-positive + false-negative)
1 secondary outcome
Near-infrared-II fluorescence intensity of tumor lesions and normal bladder mucosa
Time frame: Within 7 days after collection of ex-vivo bladder specimen, after histopathology report available
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 30 Sep 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TTP-ICG fluorescent probe in people with Bladder Cancer (BC) and Urothelial Carcinoma (UC), 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 2 inclusion and 4 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 30 Sep 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Shengjie Lin, Doctor of Medicine (86+17850112800, Linshengjie1128@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Sensitivity of ex-vivo Trop2-targeted NIR-II fluorescence imaging for detecting malignant bladder lesions (time frame: Within 7 days after collection of ex-vivo bladder specimen, after histopathology report available). The study lists 4 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 30 Sep 2026.