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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Endoscopic Bladder Cancer Diagnosis With Raman

Intervention / Treatment
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* Diagnostic Test: Raman Spectrometry


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic ability of Raman spectrometry<br>Endoscopic Raman spectrometry during endoscopic bladder cancer surgery | Diagnostic Test: Raman Spectrometry<br>* Bladder tumor is examined with Raman spectrometry during endoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of tumor grade by Raman spectometry | To achieve a clinical useful concordance between gold standard histo/cytopathological diagnosis and the information provided through Raman spectroscopy. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Examine results on the sensitivity and specificity for diagnosis (normal tissue/tumour) in 30 trial participants using the developed MIB RAMAN SYSTEM. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bladder cancer, Raman spectrometry, In vivo diagnostics