Clinical trial · Interventional
In Vivo Proof-of-principle Study of Raman Spectroscopy in Trial Participants With Bladder Tumours
NCT05124106CI-TRIAL-00055499unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endoscopic Bladder Cancer Diagnosis With Raman | Bladder Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Raman Spectrometry | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic ability of Raman spectrometry
- description
- Endoscopic Raman spectrometry during endoscopic bladder cancer surgery
- interventionNames
- Diagnostic Test: Raman Spectrometry
Primary outcomes (1)
- measure
- Diagnosis of tumor grade by Raman spectometry
- timeFrame
- 4 weeks
- description
- To achieve a clinical useful concordance between gold standard histo/cytopathological diagnosis and the information provided through Raman spectroscopy.
Secondary outcomes (1)
- measure
- To evaluate feasibility of handling the diagnostic optic equipment (MIB RAMAN SYSTEM), the Raman probe and the software, when the urologist examines the bladder for lesions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: After booking for surgery the trial participants will be informed orally about the study and written material will be given by a doctor or nurse form the study group. If the trial participant accept to enter the study, written informed consent will be obtained. The trial participant will be informed that they can withdraw the informed consent at any time and the treatment will be according to the guidelines of the department. Exclusion Criteria: * Macroscopic hematuria * Pregnant or breast-feeding women * Expected poor compliance * Persons \< 18 years * Persons who do not read or understand Danish * Dementia
References
Publications (0)
Data not yet available
No reference posted for this study.