Microscopic-spectroscopic Examination for Urothelial Tissue Characterization (MSUT)

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

Study Overview

• Status: Completed
• Conditions: Bladder Tumor
• Intervention / Treatment: Diagnostic test: Multimodal spectroscopic analysis

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 114

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients are enrolled at hospitalization in our Urology Ward for surgical operation. Patients in surgical note for TURBT for bladder cancer or for Trans-Urethral Resection of Prostate (TURP) for Benign Prostatic Hyperplasia (BPH) are prospectively enrolled.

Age, history of bladder cancer, smoke habit and anamnesis are recorded before surgery. During time of bladder or prostate resection, freshly excised cold cup biopsies of both bladder cancer or healthy bladder mucosa are taken and sent for inspection through label-free multimodal fiber optic spectroscopy (MFOS) within 30 minutes.

Specimens are sent to standard histopathological analysis. MFOS data are then compared to current gold standard methodology in order to develop a classification algorithm based on the spectral information provided by each technique.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endoscopic urologic patients; Patients with bladder cancer or benign prostate hyperplasia undergoing urologic endoscopic procedures.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnostic concordance	concordance in identifying healthy and tumor tissue between multimodal fiberoptic spectroscopy and pathology, considered as gold standard	30 minutes from resection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
grading concordance	concordance in discriminating low vs high grade tumor between multimodal fiberoptic spectroscopy and pathology, considered as gold standard	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	30 minutes from resection

Collaborators and Investigators

• Sponsor: Careggi Hospital
• Investigators: Study Chair: Simone Morselli, MD, University of Florence

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: March 13, 2020
• First Submitted That Met QC Criteria: March 13, 2020
• First Posted (Actual): March 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Spectroscopy; Pathology; Bladdder Cancer; Urothelial tumor; BCa
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: CEAVC 10325/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No