Endoscopic Bladder Cancer Diagnosis With RamanPhase 1NCT05124106
In Vivo Proof-of-principle Study of Raman Spectroscopy in Trial Participants With Bladder Tumours
A Phase 1 study testing Raman Spectrometry in people with Endoscopic Bladder Cancer Diagnosis With Raman, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopic Bladder Cancer Diagnosis With Raman
- What is being tested?
- Raman Spectrometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Nov 2021to 1 Apr 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Macroscopic hematuria
- Pregnant or breast-feeding women
- Expected poor compliance
- Persons < 18 years
- Persons who do not read or understand Danish
- Dementia
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Herlev hospital, Urology department
Herlev, Copenhagen, DK-2730
Gregers G Hermann, +4538686801, gregers.gautier.hermann@regionh.dk
Karin Mogensen, +4538686802, Karin.Mogensen@regionh.dk
About this study
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.
Read the 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.
- Being tested
- Raman Spectrometry
- Keywords
- Bladder cancer, Raman spectrometry, In vivo diagnostics
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raman SpectrometryDiagnostic test
Bladder tumor is examined with Raman spectrometry during endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic ability of Raman spectrometry | Experimental | Endoscopic Raman spectrometry during endoscopic bladder cancer surgery Receives: Diagnostic Test: Raman Spectrometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Examine results on the sensitivity and specificity for "diagnosis" (normal tissue/tumour) in 30 trial participants using the developed MIB RAMAN SYSTEM.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start22 Nov 2021
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Bladder Cancer Diagnosis With RamanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Gregers Gautier Hermann, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124106
- Sponsor's protocol ID
- Clinical Protocol (MIB)
- Status last verified
- Nov 2021
- First submitted
- 5 Nov 2021
- Last updated
- 13 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Proof-of-principle Study of Raman Spectroscopy in Trial Participants With Bladder Tumours
- ClinicalTrials.gov ID
- NCT05124106
- Acronym / sponsor ID
- Clinical Protocol (MIB)
- Keywords
- Bladder cancer, Raman spectrometry, In vivo diagnostics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- 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 start
- 22 Nov 2021 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Diagnostic ability of Raman spectrometry | Experimental | Diagnostic Test: Raman SpectrometryEndoscopic Raman spectrometry during endoscopic bladder cancer surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- Macroscopic hematuria
- Pregnant or breast-feeding women
- Expected poor compliance
- Persons < 18 years
- Persons who do not read or understand Danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Raman SpectrometryBladder tumor is examined with Raman spectrometry during endoscopy | Diagnostic test | Diagnostic ability of Raman spectrometry |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Raman Spectrometry in people with Endoscopic Bladder Cancer Diagnosis With Raman, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gregers G Hermann, DM Sc (+45 38686801, gregers.gautier.hermann@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of tumor grade by Raman spectometry (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2021.