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

November 29, 2021 updated by: Gregers Gautier Hermann, University Hospital Bispebjerg and Frederiksberg
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic ability of Raman spectrometry
Endoscopic Raman spectrometry during endoscopic bladder cancer surgery
Diagnostic test: Raman Spectrometry
Bladder tumor is examined with Raman spectrometry during endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis of tumor grade by Raman spectometry
Time Frame: 4 weeks
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.
Time Frame: 4 weeks
Examine results on the sensitivity and specificity for "diagnosis" (normal tissue/tumour) in 30 trial participants using the developed MIB RAMAN SYSTEM.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Bispebjerg and Frederiksberg

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2021

Primary Completion (Anticipated)

February 1, 2022

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

November 5, 2021

First Submitted That Met QC Criteria

November 5, 2021

First Posted (Actual)

November 17, 2021

Study Record Updates

Last Update Posted (Actual)

December 13, 2021

Last Update Submitted That Met QC Criteria

November 29, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Clinical Protocol (MIB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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