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

NCT ID: NCT05124106

Last Updated: 2021-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-22

Study Completion Date

2022-04-01

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.

Conditions

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Endoscopic Bladder Cancer Diagnosis With Raman

Keywords

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Bladder cancer Raman spectrometry In vivo diagnostics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Patient tumor stage is unknown for the examiner.

Study Groups

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Diagnostic ability of Raman spectrometry

Endoscopic Raman spectrometry during endoscopic bladder cancer surgery

Group Type EXPERIMENTAL

Raman Spectrometry

Intervention Type DIAGNOSTIC_TEST

Bladder tumor is examined with Raman spectrometry during endoscopy

Interventions

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Raman Spectrometry

Bladder tumor is examined with Raman spectrometry during endoscopy

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Proff Dr Jürgen Popp, Leibniz Institute, IPHT, Jena, Germany

UNKNOWN

Sponsor Role collaborator

Karin Mogensen urologist, Herlev hospital, Copenhagen, Denmark

UNKNOWN

Sponsor Role collaborator

Proff Dr Iwan Schie, Leibniz Institute, IPHT, Jena, Germany

UNKNOWN

Sponsor Role collaborator

University Hospital Bispebjerg and Frederiksberg

OTHER

Sponsor Role lead

Responsible Party

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Gregers Gautier Hermann

Consultant Urologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Herlev hospital, Urology department

Herlev, Copenhagen, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Gregers G Hermann, DM Sc

Role: CONTACT

Phone: +45 38686801

Email: [email protected]

Karin Mogensen, MD

Role: CONTACT

Phone: +45 38686802

Email: [email protected]

Facility Contacts

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Gregers G Hermann

Role: primary

Karin Mogensen

Role: backup

Other Identifiers

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Clinical Protocol (MIB)

Identifier Type: -

Identifier Source: org_study_id