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Optical Biopsy to Improve the Diagnosis of Kidney Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by P.G.K. Wagstaff, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02073110
First Posted: February 27, 2014
Last Update Posted: February 27, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
P.G.K. Wagstaff, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  Purpose

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.


Condition Intervention
Kidney Cancer Device: Percutaneous Optical Biopsy (OCT and DRS)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Optical Biopsy to Improve the Diagnosis of Kidney Cancer: a Prospective, Observational, Multicentre, In-vivo Study

Resource links provided by NLM:


Further study details as provided by P.G.K. Wagstaff, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • The sensitivity and specificity of DRS and OCT in the detection of renal malignancy [ Time Frame: Participants will undergo OCT/DRS measurements within 2 weeks after inclusion ]
    By measuring the OCT attenuation coefficient (µOCT) and the DRS optical blood absorption (µaHb), and correlating these values to the histopathology results.


Secondary Outcome Measures:
  • The sensitivity and specificity of DRS and OCT in differentiating between the three main RCC subtypes [ Time Frame: Participants will undergo OCT/DRS measurements within 2 weeks after inclusion ]
    By measuring the OCT attenuation coefficient (µOCT) and the DRS optical blood absorption (µaHb), and correlating these values to the histopathology results.


Estimated Enrollment: 194
Study Start Date: August 2013
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
≥ 18 years, solid enhancing renal mass suspected for RCC Device: Percutaneous Optical Biopsy (OCT and DRS)

Detailed Description:

Rationale:

Renal biopsies can be used in patients with renal mass lesions to diagnose whether it concerns a malignant or benign mass. In case of malignancy, surgery will be the following step. However, 7 to 33% of biopsies are non-diagnostic, what can result in unnecessary surgery (even up to 30% in small renal masses). The investigators think that optical biopsy (OB), a new diagnostic tool based on the absorption en reflection of light in tissues, reduces the non-diagnostic biopsy rate. This could have a direct impact on the quality of life of the patients that are therefore scheduled for an unnecessary surgical procedure. Also, concerns about overtreatment have led to the concept of focal therapy, a selective patient tailored nephron sparing surgical or ablation technique of a lesion, reducing lifetime morbidity and side effects without compromising life expectancy. For this novel form of treatment, accurate identification, grading and demarcation of a lesion is crucial and OB is the ideal platform to provide this approach to an improved cure.

Objectives:

Primary

- The accuracy of DRS and OCT in the diagnostic of renal malignancy

Secondary

  • The accuracy of DRS and OCT in the diagnostic of renal malignancy and in distinguishing among the 3 main RCC subtypes
  • The accuracy of the combination of the DRS and OCT

Study design:

This is a prospective, observational, multi-centre in-vivo study.

Study population:

Patients ≥ 18 years of age, with a solid enhancing renal mass suspected for renal cell carcinoma (RCC) and candidates for active (surgical) treatment of the renal mass.

Intervention:

Patients will receive an ultrasound guided percutaneous OB followed by a Core biopsy (CB) during the same procedure. The planned institutional surgical protocol will be followed irrespective of the results of OB and CB. During surgery (radical/partial, open/laparoscopic, percutaneous ablation) a new set of DRS and OCT measurements of the tumor and normal tissue will be performed.

Main study parameters/endpoints:

  1. To determine the accuracy of OB to differentiate renal tumor pathology from benign tissue by means of minimal invasive quantitative DRS and OCT.
  2. To determine the differentiation capability of OCT this combined technique to distinguish between the three most common RCC sub-types.
  3. To determine whether OB is a good alternative to the percutaneous biopsy for diagnosing renal cancer.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients ≥ 18 years of age, with a solid enhancing renal mass suspected for renal cell carcinoma (RCC) and candidates for active (surgical) treatment of the renal mass.
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Solid, enhancing mass on cross sectional imaging suspect for RCC
  • Scheduled for total or partial nephrectomy or for laparoscopic cryoablation.
  • Signed informed consent

Exclusion Criteria:

  • Patients with a renal mass that are not candidates for active treatment will be excluded from the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02073110


Contacts
Contact: MP Laguna Pes, MD. PhD. +31205666928 m.p.lagunapes@amc.uva.nl

Locations
Netherlands
Free University Medical Center Not yet recruiting
Amsterdam, Netherlands, 1081 HV
Contact: RJA van Moorselaar, MD. PhD.    +31204440272    Rja.vanmoorselaar@vumc.nl   
Academic Medical Center Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: MP Laguna Pes, MD. PhD.    +31205666928    m.p.lagunapes@amc.uva.nl   
Contact: Peter Wagstaff, MD.    +31205666493    p.g.wagstaff@amc.uva.nl   
Sub-Investigator: Peter Wagstaff, MD         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
Principal Investigator: MP Laguna Pes, MD. PhD. Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Chair: JJMCH de la Rosette, MD. PhD. Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

Responsible Party: P.G.K. Wagstaff, MD., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02073110     History of Changes
Other Study ID Numbers: NL41985.018.12
First Submitted: February 20, 2014
First Posted: February 27, 2014
Last Update Posted: February 27, 2014
Last Verified: February 2014

Keywords provided by P.G.K. Wagstaff, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Kidney cancer
Renal mass
Small renal mass
Optical Coherence Tomography
OCT
Diffuse Reflectance Spectroscopy
DRS
Optical Biopsy
OB

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type