Microscopic-spectroscopic Examination for Urothelial Tissue Characterization

Careggi Hospital114 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

114

Conditions

Bladder Tumor

Interventions

Multimodal spectroscopic analysisDIAGNOSTIC_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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

diagnostic concordance

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

Time frame: 30 minutes from resection

Secondary Outcomes

grading concordance

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

Time frame: 30 minutes from resection

staging concordance

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

Time frame: 30 minutes from resection

Data from ClinicalTrials.gov

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