Clinical trial NCT05124106: In Vivo Proof-of-principle Study of Raman Spectroscopy in Trial Participants With Bladder Tumours
Official title: In Vivo Proof-of-principle Study of Raman Spectroscopy in Trial Participants With Bladder Tumours
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Endoscopic Bladder Cancer Diagnosis With Raman
Keywords: Bladder cancer
Raman spectrometry
In vivo diagnostics
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
Collaborators: name: Proff Dr Jürgen Popp, Leibniz Institute, IPHT, Jena, Germany
name: Karin Mogensen urologist, Herlev hospital, Copenhagen, Denmark
name: Proff Dr Iwan Schie, Leibniz Institute, IPHT, Jena, Germany
First posted: 2021-11-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnosis of tumor grade by Raman spectometry
timeFrame: 4 weeks
Secondary outcomes:
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.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev hospital, Urology department
state: Copenhagen
Study officials:
References: