Trial Outcomes & Findings for A Randomized, Comparative Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-invasive Bladder Cancer (NCT NCT00412971)
NCT ID: NCT00412971
Last Updated: 2013-10-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
233 participants
Primary outcome timeframe
1 year
Results posted on
2013-10-11
Participant Flow
Participant milestones
| Measure |
Hexvix Cystoscopy Group
|
White Light
Standard White light cystoscopy
|
|---|---|---|
|
Overall Study
STARTED
|
115
|
118
|
|
Overall Study
COMPLETED
|
85
|
108
|
|
Overall Study
NOT COMPLETED
|
30
|
10
|
Reasons for withdrawal
| Measure |
Hexvix Cystoscopy Group
|
White Light
Standard White light cystoscopy
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
17
|
9
|
|
Overall Study
Protocol Violation
|
13
|
1
|
Baseline Characteristics
A Randomized, Comparative Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-invasive Bladder Cancer
Baseline characteristics by cohort
| Measure |
Hexvix Cystoscopy Group
n=115 Participants
|
White Light
n=118 Participants
Standard White light cystoscopy
|
Total
n=233 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
70.6 years
STANDARD_DEVIATION 11.5 • n=93 Participants
|
69.1 years
STANDARD_DEVIATION 10 • n=4 Participants
|
69.8 years
STANDARD_DEVIATION 10.7 • n=27 Participants
|
|
Gender
Female
|
75 participants
n=93 Participants
|
81 participants
n=4 Participants
|
156 participants
n=27 Participants
|
|
Gender
Male
|
27 participants
n=93 Participants
|
36 participants
n=4 Participants
|
63 participants
n=27 Participants
|
|
Region of Enrollment
Denmark
|
115 participants
n=93 Participants
|
118 participants
n=4 Participants
|
233 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: 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.
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.
Outcome measures
| Measure |
Hexvix Cystoscopy Group
n=59 Participants
|
White Light
n=74 Participants
Standard White light cystoscopy
|
|---|---|---|
|
Proportion of Patients With Histologically Confirmed Recurrence Within One 1 Year.
|
30.5 precentage of participants
Interval 19.2 to 43.9
|
47.3 precentage of participants
Interval 35.6 to 59.3
|
SECONDARY outcome
Timeframe: At day 0Population: ITT
Outcome measures
| Measure |
Hexvix Cystoscopy Group
n=90 Participants
|
White Light
Standard White light cystoscopy
|
|---|---|---|
|
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.
|
48.9 percentage of participants
Interval 38.2 to 59.7
|
—
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Hexvix Cystoscopy Group
n=102 Participants
|
White Light
n=117 Participants
Standard White light cystoscopy
|
|---|---|---|
|
False Positive Detection Rate Patient Level
|
25 percent of patients
|
16 percent of patients
|
Adverse Events
Hexvix Cystoscopy Group
Serious events: 12 serious events
Other events: 28 other events
Deaths: 0 deaths
White Light
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hexvix Cystoscopy Group
n=112 participants at risk
|
White Light
n=118 participants at risk
Standard White light cystoscopy
|
|---|---|---|
|
Renal and urinary disorders
Azotaemi
|
0.89%
1/112
|
0.00%
0/118
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesofageal carcinoma
|
0.89%
1/112
|
0.00%
0/118
|
|
Vascular disorders
Aortic aneaurysm ruptur
|
0.89%
1/112
|
0.00%
0/118
|
|
Infections and infestations
Phaumonia
|
0.89%
1/112
|
0.00%
0/118
|
|
General disorders
Cardiac death
|
0.89%
1/112
|
0.00%
0/118
|
|
Infections and infestations
Cystitis
|
0.89%
1/112
|
0.00%
0/118
|
|
Renal and urinary disorders
Urinary retention
|
4.5%
5/112
|
0.00%
0/118
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.89%
1/112
|
0.00%
0/118
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.89%
1/112
|
0.00%
0/118
|
|
Renal and urinary disorders
Urinary badder haemorrhage
|
0.00%
0/112
|
0.85%
1/118
|
|
Surgical and medical procedures
Bladder catheter temporary
|
0.00%
0/112
|
0.85%
1/118
|
|
Renal and urinary disorders
Haemutaria
|
0.00%
0/112
|
1.7%
2/118
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/112
|
0.85%
1/118
|
|
Vascular disorders
Hypertention
|
0.00%
0/112
|
0.85%
1/118
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/112
|
0.85%
1/118
|
Other adverse events
| Measure |
Hexvix Cystoscopy Group
n=112 participants at risk
|
White Light
n=118 participants at risk
Standard White light cystoscopy
|
|---|---|---|
|
Renal and urinary disorders
Urinary retention
|
14.3%
16/112
|
1.7%
2/118
|
|
Renal and urinary disorders
Haematuria
|
1.8%
2/112
|
2.5%
3/118
|
|
Renal and urinary disorders
Bladder perforation
|
1.8%
2/112
|
0.85%
1/118
|
|
Infections and infestations
Cystitis
|
1.8%
2/112
|
0.00%
0/118
|
|
Infections and infestations
Urinary tract infection
|
1.8%
2/112
|
0.00%
0/118
|
|
Infections and infestations
Infection
|
0.89%
1/112
|
0.85%
1/118
|
|
General disorders
Phyrexia
|
1.8%
2/112
|
0.00%
0/118
|
|
Immune system disorders
Hypersensitivity
|
0.89%
1/112
|
0.85%
1/118
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60