Trial Outcomes & Findings for Effectiveness of Hexaminolevulinate (Hexvix) in the Diagnosis and Treatment of Patients With Non-invasive Bladder Cancer (NCT NCT00634621)

Results Overview

Detecting the number of bladder cancer lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) with Hexvix®.

Recruitment status

COMPLETED

Target enrollment

283 participants

Primary outcome timeframe

Day 0 (Post contrast administration)

Results posted on

2014-08-25

Participant Flow

Participant milestones

Participant milestones
Measure	Hexvix 2 mg/mL Infusion Administrtation of 2 mg/mL Hexvix.
Overall Study STARTED	283
Overall Study COMPLETED	283
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of Hexaminolevulinate (Hexvix) in the Diagnosis and Treatment of Patients With Non-invasive Bladder Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hexvix n=283 Participants Use of the Hexvix drug.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	110 Participants n=5 Participants
Age, Categorical >=65 years	173 Participants n=5 Participants
Age, Continuous	67.5 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	243 Participants n=5 Participants
Region of Enrollment Spain	283 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0 (Post contrast administration)

Population: Number of True-positive lesions according to histology was 621 and broken out into various tumor stages. The Tumor stage distribution of true-positive bladder tumor lesions and their detection by White-light Cystoscopy (WLC) and/or Blue-light Cystoscopy (BLC).

Detecting the number of bladder cancer lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) with Hexvix®.

Outcome measures

Outcome measures
Measure	White-light and Blue-Light Cystoscopy Simultaneously n=283 Participants Hexvix administered using both White-light and Blue-Light Cystoscopy.	White-light Cystoscopy Only n=283 Participants Hexvix administered using only White-light Cystoscopy.	Blue-light Cystoscopy Only n=283 Participants Hexvix administered using only Blue-light Cystoscopy.	Multiple Normalized Biopsy n=283 Participants Only Multiple Normalized Biopsy.
Detecting the Rate of Bladder Cancer Lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) With Hexvix® in the Overall Study Population by Comparison With the Diagnostic Gold Standard, i.e. Histological Examination of Lesions Biopsy. Tumor Stage-Carcinoma in situ	41 Number of lesions	1 Number of lesions	31 Number of lesions	30 Number of lesions
Detecting the Rate of Bladder Cancer Lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) With Hexvix® in the Overall Study Population by Comparison With the Diagnostic Gold Standard, i.e. Histological Examination of Lesions Biopsy. Tumor Stage-Ta	236 Number of lesions	2 Number of lesions	64 Number of lesions	1 Number of lesions
Detecting the Rate of Bladder Cancer Lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) With Hexvix® in the Overall Study Population by Comparison With the Diagnostic Gold Standard, i.e. Histological Examination of Lesions Biopsy. Tumor Stage- T1	127 Number of lesions	0 Number of lesions	9 Number of lesions	2 Number of lesions
Detecting the Rate of Bladder Cancer Lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) With Hexvix® in the Overall Study Population by Comparison With the Diagnostic Gold Standard, i.e. Histological Examination of Lesions Biopsy. Tumor Stage- T2-T4	29 Number of lesions	3 Number of lesions	2 Number of lesions	1 Number of lesions
Detecting the Rate of Bladder Cancer Lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) With Hexvix® in the Overall Study Population by Comparison With the Diagnostic Gold Standard, i.e. Histological Examination of Lesions Biopsy. Tumor could not be stage-Tx	36 Number of lesions	0 Number of lesions	4 Number of lesions	2 Number of lesions
Detecting the Rate of Bladder Cancer Lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) With Hexvix® in the Overall Study Population by Comparison With the Diagnostic Gold Standard, i.e. Histological Examination of Lesions Biopsy. TOTAL	469 Number of lesions	6 Number of lesions	110 Number of lesions	36 Number of lesions

SECONDARY outcome

Timeframe: Day 0 (Post contrast administration)

Population: The number of confirmed bladder cancer was 219 identified by the standard of truth methods using the White-light cystoscopy and blue-light cystoscopy technique.

The number of confirmed bladder cancer matches using cystoscopy compared to the diagnostic gold standard, i.e. histological examination of lesions biopsy.

Outcome measures

Outcome measures
Measure	White-light and Blue-Light Cystoscopy Simultaneously n=283 Participants Hexvix administered using both White-light and Blue-Light Cystoscopy.	White-light Cystoscopy Only Hexvix administered using only White-light Cystoscopy.	Blue-light Cystoscopy Only Hexvix administered using only Blue-light Cystoscopy.	Multiple Normalized Biopsy Only Multiple Normalized Biopsy.
Assess the Sensitivity of Standard White Light Cystoscopy (WLC) and Blue Light Cystoscopy (BLC) for Obtaining a Correct Diagnosis of Bladder Cancer at Individual Patient Level. White-Light Cystoscopy-Sensitivity	86.3 Percentage of confirmed Lesions Interval 81.7 to 90.9	—	—	—
Assess the Sensitivity of Standard White Light Cystoscopy (WLC) and Blue Light Cystoscopy (BLC) for Obtaining a Correct Diagnosis of Bladder Cancer at Individual Patient Level. Blue-Light Cystoscopy-Sensitivity	90.9 Percentage of confirmed Lesions Interval 86.2 to 94.3	—	—	—

Adverse Events

Hexvix

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Emilio Moreno Carretero, M.D.

GE Healthcare

Phone: 011-34-9166-30970

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place