Optical Biopsy to Improve the Diagnosis of Kidney Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor:
Information provided by (Responsible Party):
P.G.K. Wagstaff, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT02073110
First received: February 20, 2014
Last updated: February 26, 2014
Last verified: February 2014
  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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02073110

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

Locations
Netherlands
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         
Free University Medical Center Not yet recruiting
Amsterdam, Netherlands, 1081 HV
Contact: RJA van Moorselaar, MD. PhD.    +31204440272    Rja.vanmoorselaar@vumc.nl   
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

No publications provided

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
Study First Received: February 20, 2014
Last Updated: February 26, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by 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
Adenocarcinoma
Carcinoma
Kidney Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on October 30, 2014