NCT00412971

Brief Summary

The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with suspicion of non-invasive bladder cancer. The hypothesis is to test whether the 1-year recurrence rate is different with Hexvix assisted TURB compared to standard white light TURB.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
233

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2005

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
5 years until next milestone

Results Posted

Study results publicly available

October 11, 2013

Completed
Last Updated

October 11, 2013

Status Verified

August 1, 2013

Enrollment Period

3.5 years

First QC Date

December 18, 2006

Results QC Date

August 5, 2013

Last Update Submit

August 5, 2013

Conditions

Bladder Cancer

Keywords

Recurrence of bladder cancerFluorescence cystoscopy

Outcome Measures

Primary Outcomes (1)

  • Proportion of Patients With Histologically Confirmed Recurrence Within One 1 Year.

    To compare tumour recurrence rates after standard (white light) and fluorescence guided transurethral resection of the bladder (TURB) in patients with macroscopic non-muscle invasive bladder tumour.

    1 year

Secondary Outcomes (2)

  • Proportion of Patients in the Hexvix Cystoscopy Group Who Had at Least One Additional Lesion Found by Hexvix Cystoscopy That Was Not Found by White Light Cystoscopy.

    At day 0

  • False Positive Detection Rate Patient Level

    12 months

Study Arms (2)

Hexvix cystoscopy group

ACTIVE COMPARATOR
Drug: Hexvix

White light

OTHER

Standard White light cystoscopy

Other: Standard white light cystoscopy

Interventions

HexvixDRUG

Single installation, TURB

Hexvix cystoscopy group
Standard white light cystoscopyOTHER
White light

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with suspicion of non-invasive bladder cancer indicated for a transuretheral resection of the bladder
  • Above 18 years
  • Written informed consent obtained

You may not qualify if:

  • Gross hematuria. (Note: Gross hematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may interfere with fluorescence cystoscopy. Where the bleed is light, the patient should not be excluded if in the investigator's opinion, rinsing during cystoscopy will alleviate the possible interference with fluorescence cystoscopy).
  • Patient with porphyria.
  • Known allergy to hexyl aminolevulinate hydrochloride or a similar compound.
  • Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days.
  • Pregnant or breast-feeding (all women of child-bearing potential must document a negative serum or urine pregnancy test at screening and use the contraceptive pill or intrauterine device (IUD) during the treatments and for at least one month thereafter).
  • Conditions associated with a risk of poor protocol compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Frederiksberg Hospital

Frederiksberg, 2000, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

Related Publications (1)

  • Hermann GG, Mogensen K, Carlsson S, Marcussen N, Duun S. Fluorescence-guided transurethral resection of bladder tumours reduces bladder tumour recurrence due to less residual tumour tissue in Ta/T1 patients: a randomized two-centre study. BJU Int. 2011 Oct;108(8 Pt 2):E297-303. doi: 10.1111/j.1464-410X.2011.10090.x. Epub 2011 Mar 17.

    PMID: 21414125DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

5-aminolevulinic acid hexyl ester

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Gregers G. Hermann
Organization
Fredriksberg hospital
gregershermann@hotmail.com
(+45) 38163536

Study Officials

  • Gregers G Hermann, MD, DM Sci

    Frederiksberg Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2006

First Posted

December 19, 2006

Study Start

April 1, 2005

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

October 11, 2013

Results First Posted

October 11, 2013

Record last verified: 2013-08

Locations

DK(2)