Microscopic-spectroscopic Examination for Urothelial Tissue Characterization (MSUT)

Careggi Hospital

Status: Completed

Conditions: Bladder Tumor

Treatments: Diagnostic Test: Multimodal spectroscopic analysis

Study type: Observational

Funder types: Other

Identifiers

NCT04310813

CEAVC 10325/2016

Details and patient eligibility

About

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

Full 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

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

114 participants in 1 patient group

Endoscopic urologic patients

Description:

Patients with bladder cancer or benign prostate hyperplasia undergoing urologic endoscopic procedures.

Treatment:

Diagnostic Test: Multimodal spectroscopic analysis