Trial Outcomes & Findings for Study to Improve Detection and Early Recurrence Rate in Bladder Cancer Patients Using Hexvix Fluorescence Cystoscopy (NCT NCT00233402)
NCT ID: NCT00233402
Last Updated: 2013-10-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
789 participants
Primary outcome timeframe
Day 0
Results posted on
2013-10-11
Participant Flow
A total of 814 patients were included in the study at 28 medical centers in the USA, Canada and Europe between January 2005 and September 2007.
Participant milestones
| Measure |
Comparator
Standard White Light Cystoscopy
|
Hexvix Fluorescence Cystoscopy
Standard White Light and Hexvix Fluorescence Cystoscopy
|
|---|---|---|
|
Overall Study
STARTED
|
384
|
395
|
|
Overall Study
COMPLETED
|
280
|
271
|
|
Overall Study
NOT COMPLETED
|
104
|
124
|
Reasons for withdrawal
| Measure |
Comparator
Standard White Light Cystoscopy
|
Hexvix Fluorescence Cystoscopy
Standard White Light and Hexvix Fluorescence Cystoscopy
|
|---|---|---|
|
Overall Study
No pathology data
|
12
|
9
|
|
Overall Study
No Ta/T1
|
89
|
94
|
|
Overall Study
Lost to follow up etc
|
3
|
21
|
Baseline Characteristics
Study to Improve Detection and Early Recurrence Rate in Bladder Cancer Patients Using Hexvix Fluorescence Cystoscopy
Baseline characteristics by cohort
| Measure |
Comparator
n=361 Participants
Standard White Light Cystoscopy
|
Hexvix Fluorescence Cystoscopy
n=365 Participants
Standard White Light and Hexvix Fluorescence Cystoscopy
|
Total
n=726 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
114 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
236 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
247 Participants
n=5 Participants
|
243 Participants
n=7 Participants
|
490 Participants
n=5 Participants
|
|
Age Continuous
|
69.6 years
STANDARD_DEVIATION 10.63 • n=5 Participants
|
68.5 years
STANDARD_DEVIATION 10.68 • n=7 Participants
|
69 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
284 Participants
n=5 Participants
|
278 Participants
n=7 Participants
|
562 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0Population: Analysis was based on ITT population
Outcome measures
| Measure |
Hexvix Group
n=286 Participants
The primary endpoint was assessed from patients randomized to the Hexvix group only
|
White Light Group
|
|---|---|---|
|
Proportion of Patients With >= 1 Ta or T1 Tumor Detected With Blue Light and Not White Light
|
16.4 percentage of participants
Interval 11.2 to 22.8
|
—
|
PRIMARY outcome
Timeframe: 9 monthsPopulation: ITT population
Outcome measures
| Measure |
Hexvix Group
n=271 Participants
The primary endpoint was assessed from patients randomized to the Hexvix group only
|
White Light Group
n=280 Participants
|
|---|---|---|
|
Comparison of the Proportions of Patients in the White Light Cystoscopy and Hexvix Groups Who Underwent TURB for a Histologically-confirmed Ta or T1 Tumor Who Had a Recurrence ( CIS, Ta, T1 or T2-T4 Tumor) Within 9 Months.
|
47.2 percentage of participants
|
56.1 percentage of participants
|
SECONDARY outcome
Timeframe: Day 0The false detection rate for Hexvix cystoscopy was calculated as the total number of false positive lesions (i.e. lesions that were suspected with blue light but had negative histology according to the Standard of Truth central panel read) divided by the total number of lesions that were suspected with blue light (i.e., false positive divided by false positive plus true positive). The corresponding false detection rates were also calculated for white light cystoscopy for the two groups separately.
Outcome measures
| Measure |
Hexvix Group
n=361 Participants
The primary endpoint was assessed from patients randomized to the Hexvix group only
|
White Light Group
n=365 Participants
|
|---|---|---|
|
Proportion of False Positive Lesions of Hexvix Cystoscopy and White Light Cystoscopy.
|
12 Percetange of lesion
Interval 10.2 to 14.3
|
10 Percetange of lesion
Interval 7.9 to 11.8
|
SECONDARY outcome
Timeframe: Day 0Outcome measures
| Measure |
Hexvix Group
n=41 Participants
The primary endpoint was assessed from patients randomized to the Hexvix group only
|
White Light Group
|
|---|---|---|
|
Proportion of Patients With at Least One CIS Lesion Detected With Blue Light and None Seen With White Light.
|
31.7 percentage of participants
Interval 18.1 to 48.1
|
—
|
Adverse Events
Comparator
Serious events: 32 serious events
Other events: 193 other events
Deaths: 0 deaths
Hexvix Fluorescence Cystoscopy
Serious events: 39 serious events
Other events: 202 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Comparator
n=381 participants at risk
Standard White Light Cystoscopy
|
Hexvix Fluorescence Cystoscopy
n=421 participants at risk
Standard White Light and Hexvix Fluorescence Cystoscopy
|
|---|---|---|
|
Renal and urinary disorders
Hematuria
|
1.0%
4/381 • 30 days
|
1.2%
5/421 • 30 days
|
|
Renal and urinary disorders
Urinary retention
|
1.0%
4/381 • 30 days
|
0.48%
2/421 • 30 days
|
|
Renal and urinary disorders
Bladder perforation
|
0.26%
1/381 • 30 days
|
0.00%
0/421 • 30 days
|
|
Renal and urinary disorders
Bladder tamponade
|
0.52%
2/381 • 30 days
|
0.00%
0/421 • 30 days
|
|
Renal and urinary disorders
Urinary bladder hemorrhage
|
0.26%
1/381 • 30 days
|
0.00%
0/421 • 30 days
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/381 • 30 days
|
0.24%
1/421 • 30 days
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
0.00%
0/381 • 30 days
|
0.24%
1/421 • 30 days
|
|
Renal and urinary disorders
Hydronephrosis
|
0.26%
1/381 • 30 days
|
0.24%
1/421 • 30 days
|
|
Cardiac disorders
Artrial fibrillation
|
0.26%
1/381 • 30 days
|
0.48%
2/421 • 30 days
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/381 • 30 days
|
0.48%
2/421 • 30 days
|
|
Cardiac disorders
Myocardial infarction
|
0.79%
3/381 • 30 days
|
0.48%
2/421 • 30 days
|
|
Cardiac disorders
Coronary artery disease
|
0.26%
1/381 • 30 days
|
0.00%
0/421 • 30 days
|
|
Cardiac disorders
Angina pectoris
|
0.79%
3/381 • 30 days
|
0.24%
1/421 • 30 days
|
|
Cardiac disorders
Nodal arrhythmia
|
0.00%
0/381 • 30 days
|
0.24%
1/421 • 30 days
|
|
Infections and infestations
Epiglottis
|
0.00%
0/381 • 30 days
|
0.24%
1/421 • 30 days
|
|
Infections and infestations
Influenza
|
0.00%
0/381 • 30 days
|
0.24%
1/421 • 30 days
|
|
Infections and infestations
Pheumonia
|
0.26%
1/381 • 30 days
|
0.24%
1/421 • 30 days
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/381 • 30 days
|
0.24%
1/421 • 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer
|
0.00%
0/381 • 30 days
|
0.48%
2/421 • 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.26%
1/381 • 30 days
|
0.00%
0/421 • 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/381 • 30 days
|
0.24%
1/421 • 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasms benign, malignant and unspecified
|
0.00%
0/381 • 30 days
|
0.24%
1/421 • 30 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/381 • 30 days
|
0.71%
3/421 • 30 days
|
|
Reproductive system and breast disorders
Beningn prostatic hyperplasia
|
0.26%
1/381 • 30 days
|
0.48%
2/421 • 30 days
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/381 • 30 days
|
0.24%
1/421 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Broncospasm
|
0.00%
0/381 • 30 days
|
0.24%
1/421 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/381 • 30 days
|
0.24%
1/421 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/381 • 30 days
|
0.24%
1/421 • 30 days
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.26%
1/381 • 30 days
|
0.00%
0/421 • 30 days
|
|
Surgical and medical procedures
Cystoprostatectomy
|
0.26%
1/381 • 30 days
|
0.24%
1/421 • 30 days
|
|
Surgical and medical procedures
Nephrouruterectomy
|
0.00%
0/381 • 30 days
|
0.24%
1/421 • 30 days
|
|
Surgical and medical procedures
Urinary bladder excision
|
0.26%
1/381 • 30 days
|
0.24%
1/421 • 30 days
|
|
General disorders
Asthenia
|
0.26%
1/381 • 30 days
|
0.00%
0/421 • 30 days
|
|
General disorders
Chest pain
|
0.26%
1/381 • 30 days
|
0.00%
0/421 • 30 days
|
|
General disorders
General physical health deterioration
|
0.26%
1/381 • 30 days
|
0.00%
0/421 • 30 days
|
|
General disorders
Death
|
0.26%
1/381 • 30 days
|
0.24%
1/421 • 30 days
|
|
General disorders
Gravitational edema
|
0.00%
0/381 • 30 days
|
0.24%
1/421 • 30 days
|
|
Injury, poisoning and procedural complications
Overdose
|
0.26%
1/381 • 30 days
|
0.00%
0/421 • 30 days
|
|
Injury, poisoning and procedural complications
Post procedural pulmonary embolism
|
0.26%
1/381 • 30 days
|
0.00%
0/421 • 30 days
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
0.00%
0/381 • 30 days
|
0.24%
1/421 • 30 days
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/381 • 30 days
|
0.24%
1/421 • 30 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.26%
1/381 • 30 days
|
0.00%
0/421 • 30 days
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/381 • 30 days
|
0.24%
1/421 • 30 days
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/381 • 30 days
|
0.24%
1/421 • 30 days
|
|
Psychiatric disorders
Alcohol withdraw syndrom
|
0.00%
0/381 • 30 days
|
0.24%
1/421 • 30 days
|
|
Vascular disorders
Deep vein thrombosis
|
0.26%
1/381 • 30 days
|
0.00%
0/421 • 30 days
|
|
Vascular disorders
Ischemia
|
0.00%
0/381 • 30 days
|
0.24%
1/421 • 30 days
|
|
Vascular disorders
Thrombosis
|
0.00%
0/381 • 30 days
|
0.24%
1/421 • 30 days
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/381 • 30 days
|
0.24%
1/421 • 30 days
|
|
Investigations
Blood potassium increased
|
0.00%
0/381 • 30 days
|
0.24%
1/421 • 30 days
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.26%
1/381 • 30 days
|
0.00%
0/421 • 30 days
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/381 • 30 days
|
0.24%
1/421 • 30 days
|
|
Gastrointestinal disorders
Abdominal distension
|
0.26%
1/381 • 30 days
|
0.00%
0/421 • 30 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.26%
1/381 • 30 days
|
0.00%
0/421 • 30 days
|
|
Gastrointestinal disorders
Nausea
|
0.26%
1/381 • 30 days
|
0.00%
0/421 • 30 days
|
|
Psychiatric disorders
Cofusional state
|
0.00%
0/381 • 30 days
|
0.24%
1/421 • 30 days
|
Other adverse events
| Measure |
Comparator
n=381 participants at risk
Standard White Light Cystoscopy
|
Hexvix Fluorescence Cystoscopy
n=421 participants at risk
Standard White Light and Hexvix Fluorescence Cystoscopy
|
|---|---|---|
|
Renal and urinary disorders
Hematuria
|
16.8%
64/381 • 30 days
|
15.0%
63/421 • 30 days
|
|
Renal and urinary disorders
Dysuria
|
7.3%
28/381 • 30 days
|
9.5%
40/421 • 30 days
|
|
Renal and urinary disorders
Bladder spasm
|
4.7%
18/381 • 30 days
|
4.8%
20/421 • 30 days
|
|
Renal and urinary disorders
Urinary retention
|
3.7%
14/381 • 30 days
|
4.5%
19/421 • 30 days
|
|
Renal and urinary disorders
Bladder pain
|
3.4%
13/381 • 30 days
|
4.0%
17/421 • 30 days
|
|
Renal and urinary disorders
Pollakiuria
|
2.1%
8/381 • 30 days
|
3.8%
16/421 • 30 days
|
|
Renal and urinary disorders
Micturition urgency
|
1.6%
6/381 • 30 days
|
2.4%
10/421 • 30 days
|
|
Gastrointestinal disorders
Nausea
|
3.9%
15/381 • 30 days
|
4.0%
17/421 • 30 days
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
11/381 • 30 days
|
2.9%
12/421 • 30 days
|
|
Gastrointestinal disorders
Constipation
|
2.9%
11/381 • 30 days
|
2.4%
10/421 • 30 days
|
|
Infections and infestations
Urinary tract infection
|
6.8%
26/381 • 30 days
|
6.2%
26/421 • 30 days
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.0%
19/381 • 30 days
|
6.7%
28/421 • 30 days
|
|
Vascular disorders
Hypertention
|
2.4%
9/381 • 30 days
|
4.3%
18/421 • 30 days
|
|
Vascular disorders
Hypotention
|
2.4%
9/381 • 30 days
|
0.48%
2/421 • 30 days
|
|
Psychiatric disorders
Insomnia
|
3.1%
12/381 • 30 days
|
1.9%
8/421 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place