Multimodal Spectroscopy to Detect Urothelial Cancer in Urine

Summary

To facilitate the follow-up of urothelial tumors and also make them more tolerable and less invasive for patients, there is a minimally invasive and easy to perform examination which is urinary cytology on 3 samples. This test is extremely specific, over 90% chance of cancer if it is positive and is performed by expert cytopathologists, but it is burdened by a very low sensitivity, which is especially acute in the case of low grade tumors. This makes it an extremely useful test in case of positivity, but of little use if negative or doubtful, not being able to consider it reliable.

To overcome this problem, our study aims to bring an approach based on a physical principle, that is spectroscopy, which is fast non-invasive and does not require the use of additional substances or contrast media in the diagnosis of urothelial neoplasms in samples of urine.

In our experience, multimodal optical fiber spectroscopy has proved extremely valid in discriminating healthy urothelial tissue from tumor ex vivo, as well as providing important information on the degree of urothelial neoplasia, with accuracy rates higher than 80%, for which developed the idea of a technique based on multimodal spectroscopy.

If our method proves valid, it could improve the follow up and management of patients with urothelial cancer, being able to support normal cytology and provide further support to the cytopathologist, as well as simplify the diagnosis.

Conditions

• Urothelial Carcinoma
• Urinary Bladder Cancer
• Urinary Tract Cancer

Interventions

DEVICE

Urinary Multimodal Fiber Optic Spectroscopy

Approach based on a physical principle, mainly spectroscopy, which is rapid non-invasive and does not require the use of additional substances or contrast media in the diagnosis of urothelial neoplasms in urine samples. It will be administered through a appositely designed device

DIAGNOSTIC_TEST

Urine Cytology

An expert cytopathologist will analyze urine samples to detect urinary tract cancer cells. It is the current golden standard to detect urothelial cancer in urine

PROCEDURE

Surgery

It will provide a reliable information on the presence/absence of cancer in the urinary tract (from direct visualization to pathological analysis)

Sponsors & Collaborators

• Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

  collaborator OTHER_GOV

• European Laboratory for Non-Linear Spectroscopy

  collaborator UNKNOWN

• Careggi Hospital

  collaborator OTHER

• University of Florence

  lead OTHER

Principal Investigators

• Mauro Gacci, MD · Careggi University Hospital

• Enrico Baria, PhD · European Laboratory for Non-Linear Spectroscopy

• Riccardo Cicchi, PhD · Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

• Francesco Saverio Pavone, Prof · University of Florence

• Sergio Serni, Prof · University of Florence

• Gabriella Nesi, Prof · University of Florence

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-28

Primary Completion

2023-12-20

Completion

2024-01-25

Countries

• Italy

Study Locations