Endoscopic Bladder Cancer Diagnosis With Raman
Conditions
Keywords
Bladder cancer, Raman spectrometry, In vivo diagnostics
Brief 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.
Interventions
DIAGNOSTIC_TESTRaman Spectrometry
Bladder tumor is examined with Raman spectrometry during endoscopy
Sponsors
Proff Dr Jürgen Popp, Leibniz Institute, IPHT, Jena, Germany
Karin Mogensen urologist, Herlev hospital, Copenhagen, Denmark
Proff Dr Iwan Schie, Leibniz Institute, IPHT, Jena, Germany
University Hospital Bispebjerg and Frederiksberg
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Patient tumor stage is unknown for the examiner.
Intervention model description
Tumor identified during endoscopy of the bladder is examined with Raman spectrometry. Tumor is resected. Histopathological diagnosis is compared with results of Raman spectrometry.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnosis of tumor grade by Raman spectometry | 4 weeks | To achieve a clinical useful concordance between gold standard histo/cytopathological diagnosis and the information provided through Raman spectroscopy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 4 weeks | Examine results on the sensitivity and specificity for diagnosis (normal tissue/tumour) in 30 trial participants using the developed MIB RAMAN SYSTEM. |
Countries
Denmark
Contacts
Primary ContactGregers G Hermann, DM Sc
Backup ContactKarin Mogensen, MD
Outcome results
None listed