Optical Biopsy to Improve the Diagnosis of Kidney Cancer

NCT02073110 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 194

Last updated 2014-02-27

No results posted yet for this study

Summary

Data from the American Cancer Society shows a 70% increase in incidence of kidney and renal pelvis cancer between 2000 and 2010. This increase is attributed to small renal masses (SRM) that are incidentally discovered by abdominal radiological imaging. However, 30% of resected SRMs appear benign on histological examination. Conventional biopsy is currently used to provide pathological information prior to resection. However, its non-diagnostic value is high, up to 33% in SRMs, showing the need for diagnostic improvement.

The investigators have shown that optical biopsy (OB) can differentiate malignant from benign tissue and tumor subtypes. However, translation to the clinic requires a phase 2 clinical study. The investigators will use an OB probe that can be combined with a needle puncture during classical biopsy procedures, additionally providing real time micro-scale images containing quantitative information about tissue properties. The investigators are convinced that OB will greatly improve the diagnosis of renal tumor pathology.

Conditions

Interventions

DEVICE

Percutaneous Optical Biopsy (OCT and DRS)

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • MP Laguna Pes, MD. PhD. · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  • JJMCH de la Rosette, MD. PhD. · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2016-12-31

Countries

  • Netherlands

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02073110 on ClinicalTrials.gov