Clinical trial · Observational
Multispectral Fluorescence as a Tool to Separate Healthy and Disease Related Lymphatic Anatomies in Prostate Cancer.
MultiSPectral fLuorescence Imaging as a Tool to Separate Healthy and Disease Related Lymphatic Anatomies During Lymph Node Dissections in Prostate Cancer.
NCT05120973CI-TRIAL-00079206SPLITcompletedClinicalTrials.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)
Multispectral imaging of the lymphatic draining pattern of the tumor and the abdominall wall/lower limb to evaluate technical feasibility to differentiate these patterns and in the future reduce the amount of complications that result from damage to lymphatic structures.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorescence for lymphatic mapping | Procedure | — | UNRESOLVED |
| multispectral imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- A
- description
- Tc-ICG in the prostate (SN procedure) and fluorescein unlilateral in leg or abdominal wall
- interventionNames
- Procedure: multispectral imaging
- label
- B
- description
- Free ICG bilateral in the abdominal wall
- interventionNames
- Procedure: fluorescence for lymphatic mapping
Primary outcomes (1)
- measure
- Feasibility of this intraoperative visualisation technique
- timeFrame
- During surgery
- description
- The ability to visually differentiate the draining lymphatics of the lower limbs and abdominal wall, (LNLower limb/abdominal wall; fluorescein) from the disease associated LNs (LNprostate cancer; ICG-99mTc-nanocolloid) during lymph node dissection
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria Group A: * Male, aged ≥ 18 years. * WHO performance status 0,1, or 2. * Written informed consent. * Histopathologically confirmed adenocarcinoma of the prostate * Increased risk of nodal metastases according to the Briganti 2012 nomogram (\> 7%) * Scheduled for surgical (laparoscopic) prostatectomy including ePLND- * Suitable for RP and ePLND, as per institutional guidelines Exclusion Criteria Group A: * Prior abdominal or inguinal surgery (e.g. appendectomy) * History of allergy to iodine, food or medicinal induced urticaria, asthma, eczema, or allergic rhinitis * Hyperthyroid or thyroidal adenoma * Kidney insufficiency * History of oversensitivity to FLUORESCITE composites * Patients using beta-blockers Inclusion Criteria Group B: * Male, aged ≥ 18 years. * WHO performance status 0,1, or 2. * Written informed consent. * Histopathologically confirmed adenocarcinoma of the prostate * Increased risk of nodal metastases according to the Briganti 2012 nomogram (\> 15%) * Scheduled for surgical (laparoscopic) prostatectomy including ePLND- * Suitable for RP and ePLND, as per institutional guidelines Exclusion Criteria Group B: * Prior abdominal or inguinal surgery (e.g. appendectomy) * History of allergy to iodine, food or medicinal induced urticaria, asthma, eczema, or allergic rhinitis * Hyperthyroid or thyroidal adenoma * Kidney insufficiency
References
Publications (1)
- RESULTBerrens AC, van Oosterom MN, Slof LJ, van Leeuwen FWB, van der Poel HG, Buckle T. Three-way multiplexing in prostate cancer patients - combining a bimodal sentinel node tracer with multicolor fluorescence imaging. Eur J Nucl Med Mol Imaging. 2023 Mar;50(4):1262-1263. doi: 10.1007/s00259-022-06034-x. Epub 2022 Nov 19. No abstract available. PMID 36401635