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A Randomized, Comparative Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-invasive Bladder Cancer

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ClinicalTrials.gov Identifier: NCT00412971
Recruitment Status : Completed
First Posted : December 19, 2006
Results First Posted : October 11, 2013
Last Update Posted : October 11, 2013
Sponsor:
Information provided by (Responsible Party):
Photocure

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Bladder Cancer
Interventions Drug: Hexvix
Other: Standard white light cystoscopy
Enrollment 233
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Hexvix Cystoscopy Group White Light
Hide Arm/Group Description [Not Specified] Standard White light cystoscopy
Period Title: Overall Study
Started 115 118
Completed 85 108
Not Completed 30 10
Reason Not Completed
Lost to Follow-up             17             9
Protocol Violation             13             1
Arm/Group Title Hexvix Cystoscopy Group White Light Total
Hide Arm/Group Description [Not Specified] Standard White light cystoscopy Total of all reporting groups
Overall Number of Baseline Participants 115 118 233
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 115 participants 118 participants 233 participants
70.6  (11.5) 69.1  (10) 69.8  (10.7)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 115 participants 118 participants 233 participants
Female 75 81 156
Male 27 36 63
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Denmark Number Analyzed 115 participants 118 participants 233 participants
115 118 233
1.Primary Outcome
Title Proportion of Patients With Histologically Confirmed Recurrence Within One 1 Year.
Hide Description 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.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
PP. 145 patients were eligible for tumor recurrence. 12 patients has their last follow up after 12 months. Recurrence after 12 months is based on a total of 133 patients.
Arm/Group Title Hexvix Cystoscopy Group White Light
Hide Arm/Group Description:
[Not Specified]
Standard White light cystoscopy
Overall Number of Participants Analyzed 59 74
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: precentage of participants
30.5
(19.2 to 43.9)
47.3
(35.6 to 59.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hexvix Cystoscopy Group, White Light
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in recurrence rate
Estimated Value 0.25
Estimation Comments [Not Specified]
2.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame At day 0
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Hexvix Cystoscopy Group
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 90
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
48.9
(38.2 to 59.7)
3.Secondary Outcome
Title False Positive Detection Rate Patient Level
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hexvix Cystoscopy Group White Light
Hide Arm/Group Description:
[Not Specified]
Standard White light cystoscopy
Overall Number of Participants Analyzed 102 117
Measure Type: Number
Unit of Measure: percent of patients
25 16
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Hexvix Cystoscopy Group White Light
Hide Arm/Group Description [Not Specified] Standard White light cystoscopy
All-Cause Mortality
Hexvix Cystoscopy Group White Light
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Hexvix Cystoscopy Group White Light
Affected / at Risk (%) Affected / at Risk (%)
Total   12/112 (10.71%)   4/118 (3.39%) 
General disorders     
Cardiac death *  1/112 (0.89%)  0/118 (0.00%) 
Infections and infestations     
Phaumonia *  1/112 (0.89%)  0/118 (0.00%) 
Cystitis *  1/112 (0.89%)  0/118 (0.00%) 
Injury, poisoning and procedural complications     
Post procedural haematuria *  1/112 (0.89%)  0/118 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain *  0/112 (0.00%)  1/118 (0.85%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Oesofageal carcinoma *  1/112 (0.89%)  0/118 (0.00%) 
Lung neoplasm malignant *  1/112 (0.89%)  0/118 (0.00%) 
Psychiatric disorders     
Anxiety *  0/112 (0.00%)  1/118 (0.85%) 
Renal and urinary disorders     
Azotaemi *  1/112 (0.89%)  0/118 (0.00%) 
Urinary retention *  5/112 (4.46%)  0/118 (0.00%) 
Urinary badder haemorrhage *  0/112 (0.00%)  1/118 (0.85%) 
Haemutaria *  0/112 (0.00%)  2/118 (1.69%) 
Surgical and medical procedures     
Bladder catheter temporary *  0/112 (0.00%)  1/118 (0.85%) 
Vascular disorders     
Aortic aneaurysm ruptur *  1/112 (0.89%)  0/118 (0.00%) 
Hypertention *  0/112 (0.00%)  1/118 (0.85%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1.0%
Hexvix Cystoscopy Group White Light
Affected / at Risk (%) Affected / at Risk (%)
Total   28/112 (25.00%)   8/118 (6.78%) 
General disorders     
Phyrexia *  2/112 (1.79%)  0/118 (0.00%) 
Immune system disorders     
Hypersensitivity *  1/112 (0.89%)  1/118 (0.85%) 
Infections and infestations     
Cystitis *  2/112 (1.79%)  0/118 (0.00%) 
Urinary tract infection *  2/112 (1.79%)  0/118 (0.00%) 
Infection *  1/112 (0.89%)  1/118 (0.85%) 
Renal and urinary disorders     
Urinary retention *  16/112 (14.29%)  2/118 (1.69%) 
Haematuria *  2/112 (1.79%)  3/118 (2.54%) 
Bladder perforation *  2/112 (1.79%)  1/118 (0.85%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Gregers G. Hermann
Organization: Fredriksberg hospital
Phone: (+45) 38163536
Responsible Party: Photocure
ClinicalTrials.gov Identifier: NCT00412971     History of Changes
Other Study ID Numbers: PC B304/04
First Submitted: December 18, 2006
First Posted: December 19, 2006
Results First Submitted: August 5, 2013
Results First Posted: October 11, 2013
Last Update Posted: October 11, 2013