Optical Biopsy to Improve the Diagnosis of Kidney Cancer

Optical Biopsy to Improve the Diagnosis of Kidney Cancer: a Prospective, Observational, Multicentre, In-vivo Study

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.

Study Overview

• Status: Unknown
• Conditions: Kidney Cancer
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 194

Contacts and Locations

• Study Contact: Name: MP Laguna Pes, MD. PhD.; Phone Number: +31205666928; Email: m.p.lagunapes@amc.uva.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Recruiting
    • Academic Medical Center
    • Contact: MP Laguna Pes, MD. PhD.; Phone Number: +31205666928; Email: m.p.lagunapes@amc.uva.nl
    • Contact: Peter Wagstaff, MD.; Phone Number: +31205666493; Email: p.g.wagstaff@amc.uva.nl
    • Sub-Investigator: Peter Wagstaff, MD
  • Amsterdam, Netherlands, 1081 HV
    • Not yet recruiting
    • Free University Medical Center
    • Contact: RJA van Moorselaar, MD. PhD.; Phone Number: +31204440272; Email: Rja.vanmoorselaar@vumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
≥ 18 years, solid enhancing renal mass suspected for RCC	Device: Percutaneous Optical Biopsy (OCT and DRS)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: 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)

Publications and helpful links

General Publications

• Buijs M, Wagstaff PGK, de Bruin DM, Zondervan PJ, Savci-Heijink CD, van Delden OM, van Leeuwen TG, van Moorselaar RJA, de la Rosette JJMCH, Laguna Pes MP. An In-vivo Prospective Study of the Diagnostic Yield and Accuracy of Optical Biopsy Compared with Conventional Renal Mass Biopsy for the Diagnosis of Renal Cell Carcinoma: The Interim Analysis. Eur Urol Focus. 2018 Dec;4(6):978-985. doi: 10.1016/j.euf.2017.10.002. Epub 2017 Oct 24.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: February 20, 2014
• First Submitted That Met QC Criteria: February 26, 2014
• First Posted (Estimate): February 27, 2014

Study Record Updates

• Last Update Posted (Estimate): February 27, 2014
• Last Update Submitted That Met QC Criteria: February 26, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: OCT; Kidney cancer; Optical Biopsy; Optical Coherence Tomography; Renal mass; Small renal mass; Diffuse Reflectance Spectroscopy; DRS; OB
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell
• Other Study ID Numbers: NL41985.018.12