COMPARISON OF WHITE LIGHT TRANS-URETHRAL RESECTION (TUR) VS PHOTODYNAMIC DIAGNOSIS (PDD)- GUIDED TUR AS ASSESSED BY SECOND LOOK TUR FOR THE TREATMENT OF HIGH RISK NON MUSCLE INVASIVE BLADDER CANCER (NMIBC)

COMPARISON OF WHITE LIGHT TUR VS PHOTODYNAMIC DIAGNOSIS (PDD)- GUIDED TUR AS ASSESSED BY SECOND LOOK TUR FOR THE TREATMENT OF HIGH RISK NON MUSCLE INVASIVE BLADDER CANCER (NMIBC) - Comparison of PDD vs WL-TURB in high risk NMIBC patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003898-98-IT

Enrollment

122

Registered

2013-10-02

Start date

2013-11-28

Completion date

Unknown

Last updated

2018-02-26

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

Conditions

high grade non muscle invasive bladder cancer MedDRA version: 14.1 Level: PT Classification code 10005003 Term: Bladder cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: HEXVIX Product Name: HEXVIX Pharmaceutical Form: Powder and solvent for intravesical solution

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age between 30-80 years; - Male and Female; - Suspicion of high grade (Ta/T1) or CIS non muscle invasive bladder tumour with positive cytology -Suspicion of high grade (Ta/T1) or CIS non muscle invasive bladder tumour cystoscopy on-going or suspected ecography -Written Voluntary Consent of the subject Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 51 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 71

Exclusion criteria

Exclusion criteria: - Endovesical BCG performed 3 cm in size - Presence of more than 2 lesions - Bladder stones - Upper urinary tract involvement - Concomitant second cancer - Unwilling or unable to comply with study requirement including follow up treatment - Pregnancy or Breast-feeding - Hypersensitivity to the active principle or to any of the excipients (disodium phosphate dihydrate, potassium dihydrogen phosphate, sodium chloride, hydrochloric acid, sodium hydroxide) - Porphyria documented

Design outcomes

Primary

Measure	Time frame
Main Objective: COMPARISON OF WHITE LIGHT TUR VS PHOTODYNAMIC DIAGNOSIS (PDD)- GUIDED TUR AS ASSESSED BY SECOND LOOK TUR FOR THE TREATMENT OF HIGH RISK NON MUSCLE INVASIVE BLADDER CANCER (NMIBC) ;Secondary Objective: Time to first recurrence and Time to progression (18 month follow up);Primary end point(s): Definition of residual disease at second TUR (6-8 weeks) in both groups. For residual disease means, unequivocally, the presence of at least one cell compatible with urothelial neoplasm (of any grade and stage) in the sample after the second TUR using the WHO / ISUP 2004 classification.;Timepoint(s) of evaluation of this end point: 6-8 weeks	—

Measure

Time frame

Main Objective: COMPARISON OF WHITE LIGHT TUR VS PHOTODYNAMIC DIAGNOSIS (PDD)- GUIDED TUR AS ASSESSED BY SECOND LOOK TUR FOR THE TREATMENT OF HIGH RISK NON MUSCLE INVASIVE BLADDER CANCER (NMIBC) ;Secondary Objective: Time to first recurrence and Time to progression (18 month follow up);Primary end point(s): Definition of residual disease at second TUR (6-8 weeks) in both groups. For residual disease means, unequivocally, the presence of at least one cell compatible with urothelial neoplasm (of any grade and stage) in the sample after the second TUR using the WHO / ISUP 2004 classification.;Timepoint(s) of evaluation of this end point: 6-8 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): Definition of time to first recurrence and progression in the two groups of patients at 18 month follow-up ;Timepoint(s) of evaluation of this end point: 18 months	—

Countries

Italy

Contacts

Public ContactB.U. CRO

CD Pharma Group S.r.l.

simona.manzi@cdpharma.it+390289051076

Outcome results

None listed

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