A Study of Blue Light Flexible Cystoscopy With Cysview in the Detection of Bladder Cancer in the Surveillance Setting
Summary
The purpose of this study is to investigate if blue light cystoscopy with Cysview improves detection of tumors in patients with bladder cancer during surveillance cystoscopy, using the KARL STORZ D-Light C PDD Flexible Videoscope System. Another purpose is to investigate if Cysview and blue light is safe and effective when used repeatedly.
Timeline
- Start
- 2015-10-01
- Primary completion
- 2017-04-05
- Completion
- 2017-04-05
Outcome
Met primary endpoint
paper In 13 of the 63 patients (20.6%, 95% CI 11.5-32.7) recurrence was seen only with blue light flexible cystoscopy (p <0.0001). PMID 29203268 ↗
release “a Phase 3 trial investigating Blue Light Flexible Cystoscopy (BLFC(TM)) with Cysview®/Hexvix® in the surveillance setting met the study primary end point.” photocure.com ↗
release “The Phase 3 study of Hexvix/Cysview in the surveillance patient segment met its primary endpoint” photocure.com ↗
Publications
- Pohar KS, Patel S, Lotan Y, Trabulsi E, Woods M, Downs T, Huang WC, Jones J, Taylor J, O'Donnell M, Bivalacqua TJ, DeCastro J, Steinberg G, Kamat AM, Resnick MJ, Konety B, Schoenberg M, Jones JS, Daneshmand S; Flexible Blue Light Study Group Collaborators. Safety of repeat blue light cystoscopy with hexaminolevulinate (HAL) in the management of bladder cancer: Results from a phase III, comparative, multi-center study. Urol Oncol. 2022 Aug;40(8):382.e1-382.e6. doi: 10.1016/j.urolonc.2022.04.012. Epub 2022 Jun 22.
- Smith AB, Daneshmand S, Patel S, Pohar K, Trabulsi E, Woods M, Downs T, Huang W, Taylor J, Jones J, O'Donnell M, Bivalacqua T, DeCastro J, Steinberg G, Kamat A, Resnick M, Konety B, Schoenberg M, Jones JS, Lotan Y; Flexible Blue Light Study Group Collaborators. Patient-reported outcomes of blue-light flexible cystoscopy with hexaminolevulinate in the surveillance of bladder cancer: results from a prospective multicentre study. BJU Int. 2019 Jan;123(1):35-41. doi: 10.1111/bju.14481. Epub 2018 Aug 11.
- Daneshmand S, Patel S, Lotan Y, Pohar K, Trabulsi E, Woods M, Downs T, Huang W, Jones J, O'Donnell M, Bivalacqua T, DeCastro J, Steinberg G, Kamat A, Resnick M, Konety B, Schoenberg M, Jones JS; Flexible Blue Light Study Group Collaborators. Efficacy and Safety of Blue Light Flexible Cystoscopy with Hexaminolevulinate in the Surveillance of Bladder Cancer: A Phase III, Comparative, Multicenter Study. J Urol. 2018 May;199(5):1158-1165. doi: 10.1016/j.juro.2017.11.096. Epub 2017 Dec 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | hexaminolevulinate | Small molecule | 100 mg | Other |