NCT05124106

In Vivo Proof-of-principle Study of Raman Spectroscopy in Trial Participants With Bladder Tumours

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Hospital Bispebjerg and Frederiksberg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose with this clinical investigation is to perform Raman spectroscopy inside the vivid bladder and to acquire Raman spectra of normal and tumour bladder tissue, and in a post-processing step to determine the grade of the tumor.

Detailed description

The purpose with this clinical investigation is to perform Raman spectroscopy inside the vivid bladder and to acquire Raman spectra of normal and tumour bladder tissue, and in a post-processing step to determine the grade of the bladder tumor. The recordings and overall results will be compared to standard histo/cytopathological examination of urological tissue to achieve a clinical useful concordance between gold standard histo/cytopathological diagnosis and diagnostic information established by Raman. The MIB RAMAN SYSTEM in combination with a Raman probe will be used in the operating theatre at Herlev/Copenhagen hospital urology department, where the rigid resectoscopes will be used while the trial participant is under general anesthesia. Each measurement takes about 1-5 seconds and the whole procedure with the fiber optic probes is expected to prolong the operation with 10-15 minutes.

Conditions

• Endoscopic Bladder Cancer Diagnosis With Raman

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Raman Spectrometry	Bladder tumor is examined with Raman spectrometry during endoscopy

Timeline

• Start date: 2021-11-22
• Primary completion: 2022-02-01
• Completion: 2022-04-01
• First posted: 2021-11-17
• Last updated: 2021-12-13

Locations

1 site across 1 country: Denmark