Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Percutaneous Optical Biopsy (OCT and DRS) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- ≥ 18 years, solid enhancing renal mass suspected for RCC
- interventionNames
- Device: Percutaneous Optical Biopsy (OCT and DRS)
Primary outcomes (1)
- measure
- The sensitivity and specificity of DRS and OCT in the detection of renal malignancy
- timeFrame
- Participants will undergo OCT/DRS measurements within 2 weeks after inclusion
- description
- By measuring the OCT attenuation coefficient (µOCT) and the DRS optical blood absorption (µaHb), and correlating these values to the histopathology results.
Secondary outcomes (1)
- measure
- The sensitivity and specificity of DRS and OCT in differentiating between the three main RCC subtypes
- timeFrame
- Participants will undergo OCT/DRS measurements within 2 weeks after inclusion
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBuijs 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. PMID 29079496