Clinical trial · Interventional
ICG-based Fluorescence Imaging in Localization of Prostate Cancer and Metastatic Lymph Nodes
A Pilot and Feasibility Study of Indocyanine Green-based Fluorescence Imaging in Localization of Prostate Cancer and Metastatic Lymph Nodes
NCT02840617CI-TRIAL-00023192unknownPhase 1ClinicalTrials.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)
This study aims to evaluate the feasibility of indocyanine green (ICG)-based fluorescence imaging in the detection of prostate tumors and metastatic lymph nodes. By correlating the ICG fluorescence patterns with pathologically confirmed tumor and nodal status, it would be possible to use fluorescence navigation system in helping prostate biopsy and lymph node dissection in the future.
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine Green (ICG) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ICG injection group
- description
- ICG will be intravenously administered over a 10 second period immediately after the patient was anesthetized. The fluorescence will be performed during and after the surgery, respectively.
- interventionNames
- Drug: Indocyanine Green (ICG)
Primary outcomes (1)
- measure
- sensitivity and specificity of the ICG-based fluorescence to detect prostate cancer
- timeFrame
- 1 week post-surgery
- description
- sensitivity (true positive) and specificity (true negative) of the ICG-based fluorescence to detect prostate cancer in vivo and in vitro compared to histological analysis
Secondary outcomes (1)
- measure
- sensitivity and specificity of the ICG-based fluorescence imaging to detect metastatic lymph nodes
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed prostate cancer; * Able to accept total prostatectomy; * Patient has given its informed consent. Exclusion Criteria: * Allergic to ICG or iodine; * High-grade hepatic insufficiency * refuse attending the study
References
Publications (1)
- BACKGROUNDGreco F, Cadeddu JA, Gill IS, Kaouk JH, Remzi M, Thompson RH, van Leeuwen FW, van der Poel HG, Fornara P, Rassweiler J. Current perspectives in the use of molecular imaging to target surgical treatments for genitourinary cancers. Eur Urol. 2014 May;65(5):947-64. doi: 10.1016/j.eururo.2013.07.033. Epub 2013 Aug 7. PMID 23957947