Prospective, open, tricenter phase-III diagnostic trial to evaluate cystoscopic diagnosis of non-muscle invasive bladder cancer through narrow band imaging (NBI) in comparison to white light and photodynamic diagnosis (PDD)

Prospective, open, tricenter phase-III diagnostic trial to evaluate cystoscopic diagnosis of non-muscle invasive bladder cancer through narrow band imaging (NBI) in comparison to white light and photodynamic diagnosis (PDD) - NBI/001/CD

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00000142

Enrollment

220

Registered

2009-06-18

Start date

2009-06-23

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C67

Interventions

Group 1: Cystoscopy under white light, NBI and PDD: order of the diagnostic methods is randomized.

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: · Patients that are clinically suspicious to have bladder cancer or · Patients that are cytologically or/and cystoscopically suspicious to have bladder cancer or · Patients with a history of non-muscle invasive bladder cancer (except monofocal pTaG1 and >= pT2) being in follow-up · Patient age >= 18 or = 50% · Last TUR or biopsy of the bladder or/and prostate >= 90 days · Last intravesical metaphlaxis >= 120 days · Written informed consent

Exclusion criteria

Exclusion criteria: · Patients not being clinically suspicious to have bladder cancer and patients not being cytologically or/and cystoscopically suspicious to have bladder cancer and patients without a history of non-muscle invasive bladder cancer being in follow-up · Patient age 75 years - Female patients being suspicous to be pregnant or being pregnant · Karnofsky Index < 50% · Last TUR or biopsy of the bladder or/and prostate < 90 days · Last intravesical metaphylaxis < 120 days · No written informed consent

Design outcomes

Primary

Measure	Time frame
Primary endpoints are based on white light and NBI: 1. Difference of numbers of tumors per patient detected by white light and NBI 2. Difference of sensitivities of white light and NBI 3. Sensitivities of white light and NBI (all bladder cancers) Main primary endpoint is the numbers of tumors per patient detected by white light and NBI. Auxiliary main endpoints are difference of sensitivities of white light and NBI as well as sensitivities of white light and NBI (all bladder cancers).	—

Measure

Time frame

Primary endpoints are based on white light and NBI: 1. Difference of numbers of tumors per patient detected by white light and NBI 2. Difference of sensitivities of white light and NBI 3. Sensitivities of white light and NBI (all bladder cancers) Main primary endpoint is the numbers of tumors per patient detected by white light and NBI. Auxiliary main endpoints are difference of sensitivities of white light and NBI as well as sensitivities of white light and NBI (all bladder cancers).

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Secondary

Measure	Time frame
Secondary endpoint are - Difference of detected tumors per patient NBI and PDD White light and PDD - Difference of sensitivity (all bladder cancers) NBI and PDD White light and PDD - Difference of specificity (all bladder cancers) NBI and white light NBI and PDD White light and PDD - Difference of recall rate (all bladder cancers) NBI and white light NBI and PDD White light and PDD - Estimation of recall rate and specificity (all bladder cancers) of NBI White light PDD - Estimation of sensitivity (all bladder cancers) of PDD - Positive predictive values (all bladder cancers) of NBI White light PDD - Negative predicitve values (all bladder cancers) of NBI White light PDD - Estimation of recall rate, sensitivity and specificity (all bladder cancers) of NBI and PDD together - Estimation of recall rate, sensitivity and specificity (all bladder cancers) of white light and PDD together - Sensitivity (carcinoma in situ) of NBI, white light and PDD - Interobserver variability of central pathology versus local pathology - Practikability Handling Time requirement Additional equipment	—

Measure

Time frame

Secondary endpoint are - Difference of detected tumors per patient NBI and PDD White light and PDD - Difference of sensitivity (all bladder cancers) NBI and PDD White light and PDD - Difference of specificity (all bladder cancers) NBI and white light NBI and PDD White light and PDD - Difference of recall rate (all bladder cancers) NBI and white light NBI and PDD White light and PDD - Estimation of recall rate and specificity (all bladder cancers) of NBI White light PDD - Estimation of sensitivity (all bladder cancers) of PDD - Positive predictive values (all bladder cancers) of NBI White light PDD - Negative predicitve values (all bladder cancers) of NBI White light PDD - Estimation of recall rate, sensitivity and specificity (all bladder cancers) of NBI and PDD together - Estimation of recall rate, sensitivity and specificity (all bladder cancers) of white light and PDD together - Sensitivity (carcinoma in situ) of NBI, white light and PDD - Interobserver variability of central pathology versus local pathology - Practikability Handling Time requirement Additional equipment

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Countries

Germany

Contacts

Public ContactChristian Doehn

Klinik für Urologie Universitätsklinikum Schleswig-Holstein Campus Lübeck

doehn@medinf.mu-luebeck.de0451-500-6113

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026