Microscopic-spectroscopic Examination for Urothelial Tissue Characterization

Bladder Tumor Clinical Trial

— MSUT  

Official title:

Microscopic-spectroscopic Examination for Urothelial Tissue Characterization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04310813
• Other study ID #: CEAVC 10325/2016
• Status: Completed
• Start date: November 1, 2016
• Est. completion date: March 1, 2020

Study information

• Verified date: March 2020
• Source: Careggi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To evaluate the possibility to properly discriminate between healthy bladder tissue and BCa with a multimodal fiber optic spectroscopy (MFOS) technique, in order to possibly introduce a more objective way to detect BCa, thus reducing inter-observer variability and maybe to determine urothelial carcinoma stage and grade with a comparable accuracy, specificity and sensibility of the current gold standard histopathological analysis

Description:

Observational single center study on human biological samples to evaluate the possibility to discriminate between healthy and tumor tissue on urothelial bladder samples. Aim of the study is to provide a fast, reliable and label free aid/alternative to current histopathology

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: March 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• willingness to participate,

• legal age,

• full capacity to sign informed consent

• eligibility for each surgical operation according to the best clinical practice and the urological guidelines

Exclusion Criteria:

• concomitant use of Hexaminolevulinate (Hexvix®)

• concomitant ongoing UTIs,

• concomitant bladder stone presence,

• recent catheterization or persistent bladder catheterization at time of surgery,

• concomitant presence of other pelvic cancer (both prostate, urethral, uterine),

• previous chemotherapy or radiotherapy of the pelvis,

• patient refusal at informed consent.

Related Conditions & MeSH terms

• Bladder Tumor
• Urinary Bladder Neoplasms

Intervention

Diagnostic Test:
• Multimodal spectroscopic analysis
During time of bladder or prostate resection, freshly excised cold cup biopsies of both bladder cancer or healthy bladder mucosa were taken and sent for inspection through label-free multimodal fiber optic spectroscopy (MFOS) within 30 minutes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Careggi Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic concordance	concordance in identifying healthy and tumor tissue between multimodal fiberoptic spectroscopy and pathology, considered as gold standard	30 minutes from resection
Secondary	grading concordance	concordance in discriminating low vs high grade tumor between multimodal fiberoptic spectroscopy and pathology, considered as gold standard	30 minutes from resection
Secondary	staging concordance	concordance in discriminating Ta vs T1 vs T2 tumors between multimodal fiberoptic spectroscopy and pathology, considered as gold standard	30 minutes from resection