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

NCT05124106 | Unknown Phase 1 DMC

• 1 other identifier: Clinical Protocol (MIB)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Endoscopic Bladder Cancer Diagnosis With Raman

Keywords

Bladder cancer; Raman spectrometry; In vivo diagnostics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Diagnostic ability of Raman spectrometry

EXPERIMENTAL

Endoscopic Raman spectrometry during endoscopic bladder cancer surgery

Diagnostic Test: Raman Spectrometry

Interventions

Raman Spectrometry DIAGNOSTIC_TEST

Bladder tumor is examined with Raman spectrometry during endoscopy

Diagnostic ability of Raman spectrometry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Macroscopic hematuria
• Pregnant or breast-feeding women
• Expected poor compliance
• Persons \< 18 years
• Persons who do not read or understand Danish
• Dementia

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead
• Proff Dr Jürgen Popp, Leibniz Institute, IPHT, Jena, Germany: collaborator
• Karin Mogensen urologist, Herlev hospital, Copenhagen, Denmark: collaborator
• Proff Dr Iwan Schie, Leibniz Institute, IPHT, Jena, Germany: collaborator

Study Sites (1)

Herlev hospital, Urology department

Herlev, Copenhagen, DK-2730, Denmark

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Gregers G Hermann, DM Sc

CONTACT

+45 38686801; gregers.gautier.hermann@regionh.dk

Karin Mogensen, MD

CONTACT

+45 38686802; Karin.Mogensen@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Patient tumor stage is unknown for the examiner.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Urologist

Model Details: Tumor identified during endoscopy of the bladder is examined with Raman spectrometry. Tumor is resected. Histopathological diagnosis is compared with results of Raman spectrometry.

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 17, 2021
• Study Start: November 22, 2021
• Primary Completion: February 1, 2022
• Study Completion: April 1, 2022
• Last Updated: December 13, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)