Microscopic-spectroscopic Examination for Urothelial Tissue Characterization

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multimodal spectroscopic analysis

Diagnostic Test

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

Primary outcomes

diagnostic concordance

Time frame: 30 minutes from resection

concordance in identifying healthy and tumor tissue between multimodal fiberoptic spectroscopy and pathology, considered as gold standard

Secondary outcomes

grading concordance

Time frame: 30 minutes from resection

concordance in discriminating low vs high grade tumor between multimodal fiberoptic spectroscopy and pathology, considered as gold standard
staging concordance

Time frame: 30 minutes from resection

concordance in discriminating Ta vs T1 vs T2 tumors between multimodal fiberoptic spectroscopy and pathology, considered as gold standard

Sponsors and collaborators

Lead sponsor

Careggi Hospital

Other

Registry information

Acronym: MSUT

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2020
First posted: Mar 17, 2020
Registry last updated: Mar 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed