Trop2-Targeted NIR-II Fluorescent Probe for Identifying Bladder Cancer in Ex Vivo Bladder Samples
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorYunnan Cancer Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Suspected or confirmed bladder tumor patients who are scheduled to undergo radical cystectomy.
Able to provide written informed consent and comply with study protocol.
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
TTP-ICG fluorescent probe
DrugAfter 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: TTP-ICG ex-vivo rapid incubation fluorescence imagingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Within 7 days after collection of ex-vivo bladder specimen, after histopathology report available2
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)
Time frame
Within 7 days after collection of ex-vivo bladder specimen, after histopathology report available3
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)
Time frame
Within 7 days after collection of ex-vivo bladder specimen, after histopathology report available4
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)
Time frame
Within 7 days after collection of ex-vivo bladder specimen, after histopathology report availableSecondary 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
Time frame
Within 7 days after collection of ex-vivo bladder specimen, after histopathology report availableSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov