Photodynamisk Diagnostik (PDD) ved flexible cystoskopier - et randomiseret studie med fokus på recidiv

Photodynamic diagnosis (PDD) in flexible cystoscopy – a randomized study with focus on significant recurrence

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000436-15-DK

Enrollment

696

Registered

2015-03-10

Start date

2015-05-18

Completion date

Unknown

Last updated

2019-12-10

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

Conditions

Patients with non muscle invasive bladder cancer in their first year after the diagnosis. MedDRA version: 18.0 Level: LLT Classification code 10005004 Term: Bladder cancer NOS System Organ Class: 100000004864

Interventions

Trade Name: Hexvix Product Name: Hexvix Pharmaceutical Form: Powder and solvent for intravesical suspension

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: age over 18 years first time TUR-B where the pathology showed Ta ( LG and HG) informed consent on the basis of oral and written information 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 696 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 696

Exclusion criteria

Exclusion criteria: lack of consent communication problems missing or incomplete implementation of the procedure and Hexvix installation active cystitis catheter in the bladder ( chronic) AK treatment apart from aspirin Treatment with BCG in the meantime between TUR-B and study inclusion

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Primary end points: To see if there has been any recurrences at 8 months and 12 months cystoscopy in both groups. ;Timepoint(s) of evaluation of this end point: 18 months in total;Main Objective: The Hypothesis of this study is that the use of PDD in the outpatient clinic in patients with a high recurrence risk undergoing follow-up flexible cystoscopy will result in diagnosis of papillomas earlier than by the use of conventional flexible cystoscopy in white light. Thus, a higher number of tumours can be treated in the outpatient setting without the need for procedures in general anaesthesia. Furthermore, the number of follow-up cystoscopies can be reduced if PDD is used at the first cystoscopy following TURB.; Secondary Objective: Primary end points: To see if there has been any recurrences at 8 months and 12 months cystoscopy in both groups. Secondary end points: Number of procedures in general anesthesia within the first 12 months after the first transuretral resection (TUR-B). tumor recurrence and size. tumor progression stage. identification of flat dysplasia and CIS.	—

Measure

Time frame

Primary end point(s): Primary end points: To see if there has been any recurrences at 8 months and 12 months cystoscopy in both groups. ;Timepoint(s) of evaluation of this end point: 18 months in total;Main Objective: The Hypothesis of this study is that the use of PDD in the outpatient clinic in patients with a high recurrence risk undergoing follow-up flexible cystoscopy will result in diagnosis of papillomas earlier than by the use of conventional flexible cystoscopy in white light. Thus, a higher number of tumours can be treated in the outpatient setting without the need for procedures in general anaesthesia. Furthermore, the number of follow-up cystoscopies can be reduced if PDD is used at the first cystoscopy following TURB.; Secondary Objective: Primary end points: To see if there has been any recurrences at 8 months and 12 months cystoscopy in both groups. Secondary end points: Number of procedures in general anesthesia within the first 12 months after the first transuretral resection (TUR-B). tumor recurrence and size. tumor progression stage. identification of flat dysplasia and CIS.

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 18 months in total; Secondary end point(s): Secondary end points: Number of procedures in general anesthesia within the first 12 months after the first transuretral resection (TUR-B). tumor recurrence and size. tumor progression stage. identification of flat dysplasia and CIS.	—

Countries

Denmark

Contacts

Public ContactJørgen Bjerggaard Jensen

Aarhus Universitets Hospital

Bjerggaard@skejby.rm.dk+45 78452617

Outcome results

None listed

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