Phase 3
N=158
Comparative Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer
Bladder Cancer
Bottom Line
View on ClinicalTrials.gov: NCT05600322 ↗Enrolled (actual)
158
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: 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. — 42 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Hexaminolevulinate Hydrochloride (Drug); Richard Wolf Photodynamic Diagnostic Equipment (PDD) system (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Photocure
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
42 | — |
| SECONDARY Number of Subjects With at Least One Additional CIS Lesion Detected With Hexvix Blue Light Cystoscopy But Not With White Light Cystoscopy. |
11 | — |
| SECONDARY 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). |
0; 0; 94.7; 42.1; 100; 76.1 | — |
| SECONDARY The Proportion of False Positive Lesions Detected With Hexvix Blue Light Cystoscopy and White Light Cystoscopy. |
23.2; 16.0 | — |
Summary
A study to compare Hexvix Blue light cstoscopy with standard White light cystoscopy in the detection of bladder cancer.
Eligibility Criteria
Inclusion Criteria
- Volunteer to participate in clinical study; thoroughly informed, signed and dated the informed consent form; willing to follow and have the ability to complete all trial procedures.
- Suspicious or confirmed patients with bladder cancer.
- Age 18 or older.
Exclusion Criteria
- Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may visually limit cystoscopy. Where the haematuria is light, the patient should not be excluded, if in the investigator's opinion, rinsing and/or electro-cautery during cystoscopy will alleviate the possible interference with cystoscopy).
- Patients who have received BCG immunotherapy or intravesical chemotherapy within the past 6 weeks prior to the procedure.
- Porphyria.
- Known allergy to hexaminolevulinate hydrochloride or a similar compound.
- Pregnancy or breast-feeding or women who plan to become pregnant during the trial, and men or women who are unwilling to take barrier contraceptives from 2 weeks before application of investigational medication to 28 days after application of investigational medication (Note: All women of child-bearing potential must document a negative urine pregnancy test before study inclusion and use adequate contraception during the study.
- Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days.
- Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
- Patients that the investigator assessed unsuitable to the study.
- Subjects with contraindications to white light cystoscopy.
Data sourced from ClinicalTrials.gov (NCT05600322). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.