Trial Outcomes & Findings for Comparative Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer (NCT NCT05600322)
NCT ID: NCT05600322
Last Updated: 2024-10-03
Results Overview
In the subsection of patients with histology-confirmed lesions (Ta, T1, or CIS) , the number of patients who have at least one such lesion found by Hexvix blue light cystoscopy but not by white light cystoscopy is measured.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
158 participants
Primary outcome timeframe
1 day (At time of cystoscopy examination)
Results posted on
2024-10-03
Participant Flow
Participant milestones
| Measure |
Hexvix Blue Light Cystoscopy
In this study, enrolled patients will undergo standard White light cystoscopy and Blue light cystoscopy following Hexvix administration. Lesions detected during the cystoscopies will be resected or biopsied.
Hexaminolevulinate Hydrochloride: Enrolled patients will be instilled with 50 mL hexaminolevulinate hydrochloride as intravesical solution (Hexvix) in the bladder for one hour at Visit 2. After bladder evacuation, the cystoscopic examinations will be performed in both white and blue light.
Richard Wolf Photodynamic Diagnostic Equipment (PDD) system: Cystoscopy in White and Blue light will be done using the Richard Wolf PDD system.
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|---|---|
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Overall Study
STARTED
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158
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Overall Study
COMPLETED
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157
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer
Baseline characteristics by cohort
| Measure |
Hexvix Blue Light Cystoscopy
n=114 Participants
In this study, enrolled patients will undergo standard White light cystoscopy and Blue light cystoscopy following Hexvix administration. Lesions detected during the cystoscopies will be resected or biopsied.
Hexaminolevulinate Hydrochloride: Enrolled patients will be instilled with 50 mL hexaminolevulinate hydrochloride as intravesical solution (Hexvix) in the bladder for one hour at Visit 2. After bladder evacuation, the cystoscopic examinations will be performed in both white and blue light.
Richard Wolf Photodynamic Diagnostic Equipment (PDD) system: Cystoscopy in White and Blue light will be done using the Richard Wolf PDD system.
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|---|---|
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Age, Continuous
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65.3 years
STANDARD_DEVIATION 12.18 • n=5 Participants
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Sex: Female, Male
Female
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22 Participants
n=5 Participants
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Sex: Female, Male
Male
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92 Participants
n=5 Participants
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Race/Ethnicity, Customized
Han nationality
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112 Participants
n=5 Participants
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Race/Ethnicity, Customized
Others
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2 Participants
n=5 Participants
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Region of Enrollment
China
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114 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 1 day (At time of cystoscopy examination)Population: Patients with histology-confirmed lesions (Ta, T1, or CIS) were included in the Modified Full Analysis Set (mFAS)
In the subsection of patients with histology-confirmed lesions (Ta, T1, or CIS) , the number of patients who have at least one such lesion found by Hexvix blue light cystoscopy but not by white light cystoscopy is measured.
Outcome measures
| Measure |
Hexvix Blue Light Cystoscopy
n=97 Participants
In this study, enrolled patients will undergo standard White light cystoscopy and Blue light cystoscopy following Hexvix administration. Lesions detected during the cystoscopies will be resected or biopsied.
Hexaminolevulinate Hydrochloride: Enrolled patients will be instilled with 50 mL hexaminolevulinate hydrochloride as intravesical solution (Hexvix) in the bladder for one hour at Visit 2. After bladder evacuation, the cystoscopic examinations will be performed in both white and blue light.
Richard Wolf Photodynamic Diagnostic Equipment (PDD) system: Cystoscopy in White and Blue light will be done using the Richard Wolf PDD system.
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|---|---|
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Number of Patients With Histology-confirmed Lesions (Ta, T1, or CIS) Who Have at Least One Such Lesion Found by Hexvix Blue Light Cystoscopy But Not by White Light Cystoscopy.
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42 Participants
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SECONDARY outcome
Timeframe: 1 day (At time of cystoscopy examination)Population: Patients randomised to undergo white light cystoscopy and Hexvix blue light cystoscopy were included in the Full Analysis Set (FAS)
Outcome measures
| Measure |
Hexvix Blue Light Cystoscopy
n=114 Participants
In this study, enrolled patients will undergo standard White light cystoscopy and Blue light cystoscopy following Hexvix administration. Lesions detected during the cystoscopies will be resected or biopsied.
Hexaminolevulinate Hydrochloride: Enrolled patients will be instilled with 50 mL hexaminolevulinate hydrochloride as intravesical solution (Hexvix) in the bladder for one hour at Visit 2. After bladder evacuation, the cystoscopic examinations will be performed in both white and blue light.
Richard Wolf Photodynamic Diagnostic Equipment (PDD) system: Cystoscopy in White and Blue light will be done using the Richard Wolf PDD system.
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|---|---|
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Number of Subjects With at Least One Additional CIS Lesion Detected With Hexvix Blue Light Cystoscopy But Not With White Light Cystoscopy.
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11 Participants
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SECONDARY outcome
Timeframe: 1 day (At time of cystoscopy examination)Population: The total number of lesions in the full analysis set
Outcome measures
| Measure |
Hexvix Blue Light Cystoscopy
n=306 Lesions
In this study, enrolled patients will undergo standard White light cystoscopy and Blue light cystoscopy following Hexvix administration. Lesions detected during the cystoscopies will be resected or biopsied.
Hexaminolevulinate Hydrochloride: Enrolled patients will be instilled with 50 mL hexaminolevulinate hydrochloride as intravesical solution (Hexvix) in the bladder for one hour at Visit 2. After bladder evacuation, the cystoscopic examinations will be performed in both white and blue light.
Richard Wolf Photodynamic Diagnostic Equipment (PDD) system: Cystoscopy in White and Blue light will be done using the Richard Wolf PDD system.
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Number of Lesions Detected With Hexvix Blue Light Cystoscopy and White Light Cystoscopy for Following Lesion Types (Papillary Urothelial Neoplasm of Low Malignant Potential (PUNLMP), Carcinoma in Situ (CIS), Ta, T1, T2-T4).
PUNLMP lesion detection rate Blue light
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0 percentage of lesions
0 PUNLMP lesions detected in Blue light
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Number of Lesions Detected With Hexvix Blue Light Cystoscopy and White Light Cystoscopy for Following Lesion Types (Papillary Urothelial Neoplasm of Low Malignant Potential (PUNLMP), Carcinoma in Situ (CIS), Ta, T1, T2-T4).
PUNLMP lesion detection rate White light
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0 percentage of lesions
0 PUNLMP lesions detected in Blue light
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Number of Lesions Detected With Hexvix Blue Light Cystoscopy and White Light Cystoscopy for Following Lesion Types (Papillary Urothelial Neoplasm of Low Malignant Potential (PUNLMP), Carcinoma in Situ (CIS), Ta, T1, T2-T4).
CIS lesion detection rate Blue light
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94.7 percentage of lesions
Interval 74.0 to 99.9
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Number of Lesions Detected With Hexvix Blue Light Cystoscopy and White Light Cystoscopy for Following Lesion Types (Papillary Urothelial Neoplasm of Low Malignant Potential (PUNLMP), Carcinoma in Situ (CIS), Ta, T1, T2-T4).
CIS lesion detection rate White light
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42.1 percentage of lesions
Interval 20.3 to 66.5
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Number of Lesions Detected With Hexvix Blue Light Cystoscopy and White Light Cystoscopy for Following Lesion Types (Papillary Urothelial Neoplasm of Low Malignant Potential (PUNLMP), Carcinoma in Situ (CIS), Ta, T1, T2-T4).
Ta lesion detection rate Blue light
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100 percentage of lesions
Interval 98.4 to 100.0
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Number of Lesions Detected With Hexvix Blue Light Cystoscopy and White Light Cystoscopy for Following Lesion Types (Papillary Urothelial Neoplasm of Low Malignant Potential (PUNLMP), Carcinoma in Situ (CIS), Ta, T1, T2-T4).
Ta lesion detection rate White light
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76.1 percentage of lesions
Interval 70.0 to 81.5
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Number of Lesions Detected With Hexvix Blue Light Cystoscopy and White Light Cystoscopy for Following Lesion Types (Papillary Urothelial Neoplasm of Low Malignant Potential (PUNLMP), Carcinoma in Situ (CIS), Ta, T1, T2-T4).
T1 lesion detection rate Blue light
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98.2 percentage of lesions
Interval 90.6 to 100.0
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Number of Lesions Detected With Hexvix Blue Light Cystoscopy and White Light Cystoscopy for Following Lesion Types (Papillary Urothelial Neoplasm of Low Malignant Potential (PUNLMP), Carcinoma in Situ (CIS), Ta, T1, T2-T4).
T1 lesion detection rate White light
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91.2 percentage of lesions
Interval 80.7 to 97.1
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Number of Lesions Detected With Hexvix Blue Light Cystoscopy and White Light Cystoscopy for Following Lesion Types (Papillary Urothelial Neoplasm of Low Malignant Potential (PUNLMP), Carcinoma in Situ (CIS), Ta, T1, T2-T4).
T2-T4 lesion detection rate Blue light
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100 percentage of lesions
Interval 39.8 to 100.0
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Number of Lesions Detected With Hexvix Blue Light Cystoscopy and White Light Cystoscopy for Following Lesion Types (Papillary Urothelial Neoplasm of Low Malignant Potential (PUNLMP), Carcinoma in Situ (CIS), Ta, T1, T2-T4).
T2-T4 lesion detection rate White light
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100 percentage of lesions
Interval 39.8 to 100.0
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SECONDARY outcome
Timeframe: 1 day (At time of cystoscopy examination)Population: Patients that were randomised to undergo standard White light cystoscopy and Hexvix Blue light cystoscopy.
Outcome measures
| Measure |
Hexvix Blue Light Cystoscopy
n=114 Participants
In this study, enrolled patients will undergo standard White light cystoscopy and Blue light cystoscopy following Hexvix administration. Lesions detected during the cystoscopies will be resected or biopsied.
Hexaminolevulinate Hydrochloride: Enrolled patients will be instilled with 50 mL hexaminolevulinate hydrochloride as intravesical solution (Hexvix) in the bladder for one hour at Visit 2. After bladder evacuation, the cystoscopic examinations will be performed in both white and blue light.
Richard Wolf Photodynamic Diagnostic Equipment (PDD) system: Cystoscopy in White and Blue light will be done using the Richard Wolf PDD system.
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The Proportion of False Positive Lesions Detected With Hexvix Blue Light Cystoscopy and White Light Cystoscopy.
False positive detection rate Blue light
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23.2 percentage of false positive lesions
Interval 19.2 to 27.7
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The Proportion of False Positive Lesions Detected With Hexvix Blue Light Cystoscopy and White Light Cystoscopy.
False positive detection rate White light
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16.0 percentage of false positive lesions
Interval 11.9 to 20.8
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OTHER_PRE_SPECIFIED outcome
Timeframe: 1 weekPopulation: Patients who received Hexvix instillation were included in the safety population.
Outcome measures
| Measure |
Hexvix Blue Light Cystoscopy
n=158 Participants
In this study, enrolled patients will undergo standard White light cystoscopy and Blue light cystoscopy following Hexvix administration. Lesions detected during the cystoscopies will be resected or biopsied.
Hexaminolevulinate Hydrochloride: Enrolled patients will be instilled with 50 mL hexaminolevulinate hydrochloride as intravesical solution (Hexvix) in the bladder for one hour at Visit 2. After bladder evacuation, the cystoscopic examinations will be performed in both white and blue light.
Richard Wolf Photodynamic Diagnostic Equipment (PDD) system: Cystoscopy in White and Blue light will be done using the Richard Wolf PDD system.
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The Number of Patients With Adverse Events (AE) During the Study.
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95 Participants
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Adverse Events
Hexvix Blue Light Cystoscopy
Serious events: 0 serious events
Other events: 95 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hexvix Blue Light Cystoscopy
n=158 participants at risk
In this study, enrolled patients will undergo standard White light cystoscopy and Blue light cystoscopy following Hexvix administration. Lesions detected during the cystoscopies will be resected or biopsied.
Hexaminolevulinate Hydrochloride: Enrolled patients will be instilled with 50 mL hexaminolevulinate hydrochloride as intravesical solution (Hexvix) in the bladder for one hour at Visit 2. After bladder evacuation, the cystoscopic examinations will be performed in both white and blue light.
Richard Wolf Photodynamic Diagnostic Equipment (PDD) system: Cystoscopy in White and Blue light will be done using the Richard Wolf PDD system.
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Metabolism and nutrition disorders
Hypoalbuminaemia
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20.9%
33/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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Metabolism and nutrition disorders
Hyperglycaemia
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2.5%
4/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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Metabolism and nutrition disorders
Hypocalcaemia
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1.3%
2/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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Metabolism and nutrition disorders
Decreased appetite
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0.63%
1/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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Metabolism and nutrition disorders
Hypokalaemia
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0.63%
1/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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Metabolism and nutrition disorders
Hypoproteinaemia
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0.63%
1/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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Renal and urinary disorders
Haematuria
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6.3%
10/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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Renal and urinary disorders
Dysuria
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3.8%
6/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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Renal and urinary disorders
Urethral pain
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3.8%
6/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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Renal and urinary disorders
Bladder spasm
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1.9%
3/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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Renal and urinary disorders
Bladder pain
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1.3%
2/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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Renal and urinary disorders
Ureteral spasm
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1.3%
2/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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Renal and urinary disorders
Renal failure
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0.63%
1/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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Renal and urinary disorders
Urethral stenosis
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0.63%
1/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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Renal and urinary disorders
Urethral syndrome
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0.63%
1/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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Renal and urinary disorders
Urinary tract pain
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0.63%
1/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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Renal and urinary disorders
Urinary tract spasm
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0.63%
1/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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Investigations
Blood bilirubin increased
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8.9%
14/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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Investigations
Blood pressure increased
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3.2%
5/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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Investigations
Lymphocyte count decreased
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3.2%
5/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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Investigations
Blood albumin decreased
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1.3%
2/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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Investigations
Alanine aminotransferase increased
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0.63%
1/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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Investigations
Blood glucose increased
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0.63%
1/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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Investigations
Fibrin D dimer increased
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0.63%
1/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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Injury, poisoning and procedural complications
Incision site pain
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10.8%
17/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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Injury, poisoning and procedural complications
Post procedural haematuria
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1.3%
2/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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Gastrointestinal disorders
Constipation
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5.7%
9/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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Gastrointestinal disorders
Abdominal pain lower
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3.8%
6/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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Gastrointestinal disorders
Diarrhoea
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1.3%
2/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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Gastrointestinal disorders
Dyschezia
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0.63%
1/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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Infections and infestations
Urinary tract infection
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8.9%
14/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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Infections and infestations
Upper respiratory tract infection
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1.3%
2/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
|
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Infections and infestations
Bacteraemia
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0.63%
1/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
|
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Blood and lymphatic system disorders
Anaemia
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8.2%
13/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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General disorders
Pyrexia
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3.8%
6/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
|
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General disorders
Fatigue
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0.63%
1/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
|
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General disorders
Inflammation
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0.63%
1/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
|
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General disorders
Peripheral swelling
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0.63%
1/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
|
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Vascular disorders
Hypotension
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0.63%
1/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
|
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Vascular disorders
Peripheral venous disease
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0.63%
1/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
|
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Vascular disorders
Venous thrombosis limb
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0.63%
1/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
|
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Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
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0.63%
1/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
|
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Respiratory, thoracic and mediastinal disorders
Laryngeal discomfort
|
0.63%
1/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
|
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Cardiac disorders
Bradycardia
|
0.63%
1/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
|
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Cardiac disorders
Tachycardia
|
0.63%
1/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
|
|
Eye disorders
Vitreous floaters
|
0.63%
1/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.63%
1/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
|
|
Nervous system disorders
Dizziness
|
0.63%
1/158 • Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place