Clinical trial · Interventional
Intraoperative Folate Targeted Fluorescence in Renal Cell Carcinoma
NCT02645409CI-TRIAL-00043622completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
Primary • To explore the use of OTL38 and fluorescence imaging to detect RCC in partial nephrectomy at the margins of resection, and in lymph node(s) or other metastases during radical nephrectomy.
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 |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraoperative fluorescence imaging system | Device | — | UNRESOLVED |
| OTL38 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Partial nephrectomy
- description
- OTL38 will be given approximately 2 hours before surgery. Intraoperative fluorescent imaging will utilized in parallel with standard operating procedures for partial nephrectomy. Photographs of the surgery field and tumor (ex-vivo) will be taken under normal light and fluorescent light.
- interventionNames
- Drug: OTL38
- Device: Intraoperative fluorescence imaging system
- type
- EXPERIMENTAL
- label
- Radical nephrectomy
- description
- OTL38 will be given approximately 2 hours before surgery. Intraoperative fluorescent imaging will utilized in parallel with standard operating procedures for radical nephrectomy. Photographs of the surgery field and tumor (ex-vivo) will be taken under normal light and fluorescent light.
- interventionNames
- Drug: OTL38
- Device: Intraoperative fluorescence imaging system
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria for localized RCC treated with partial nephrectomy To be considered eligible to participate in this study, a patient must meet all the inclusion criteria listed below: * ≥ 18 years of age. * Have primary or suspected diagnosis of RCC, with presence of cT1-2 renal mass by diagnostic CT assessment. * Scheduled for partial nephrectomy of renal mass. * Expected survival of at least 3 months. * Written informed consent available. * ECOG ≤ 1 (Appendix G). * Negative serum or urine pregnancy test within 24 hours for females of child bearing age * Recovered from toxicity of any prior therapy to ≥ grade 1. Inclusion criteria for advanced RCC treated with radical nephrectomy To be considered eligible to participate in this study, a patient must meet all the inclusion criteria listed below: * ≥ 18 years of age. * Have pathologic or suspected diagnosis of RCC with presence of cT1-4 renal mass and evidence of nodal or metastatic involvement by diagnostic CT assessment * Scheduled for radical nephrectomy and lymph node dissection. * Expected survival of at least 3 months. * ECOG ≤ 2. * Negative serum or urine pregnancy test within 24 hours for females of child bearing age. * Recovered from toxicity of any prior therapy to ≥ grade 1 * Written informed consent available. Exclusion criteria for both localized and advanced RCC * History of any anaphylactic reaction, any severe allergy, or any allergy to folate. * Brain metastases * Baseline GFR \< 50 mL/min/1.73m2) * Hepatic toxicity ≥ Grade 2 (using CTCAE version 4 standard definitions). * Participation in another investigational drug trial either concurrently or 30 days prior to surgery * Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient, limit the patient's ability to complete the study, and/or compromise the objectives of the study. * Known sensitivity to fluorescent light
References
Publications (0)
Data not yet available
No reference posted for this study.