Clinical trial · Interventional
A Dose-Image Optimization Trial Evaluating Mannitol and Voluven as Adjuncts for Indocyanine Green
Advanced Research on ICG Fluorescence Imaging-Guided Surgery Technique Using Mannitol and Voluven as Adjuncts
- 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)
The goal of this clinical trial is to exploring the use of Mannitol 20% as a solvent to prepare ICG solution, combining with Voluven, forming a hybrid small-large molecular weight solvent for protecting ICG in monomer form and stimulating lymphatic uptake simultaneously in early breast cancer patients who is indicated to undergo sentinel lymph node biopsy. The main question it aims to answer is: * Will adding Mannitol with Voluven as ICG solvent improve the fluorescence signal of the lymph nodes, comparing with using pure Voluven? * Which proportion of Mannitol-Voluven delivers the best image quality when used as solvent of ICG? Researchers will compare the following arms with different solvent (all arms' final ICG concentration are 0.25mg/mL): * Pure Voluven * Mannitol:Voluven = 1:10 * Mannitol:Voluven = 1:8 * Mannitol:Voluven = 1:6 * Mannitol:Voluven = 1:4 to see if increased Mannitol:Voluven ratio as ICG solvent translates to better fluorescence image quality. Participants will be invited in a group of 3, and be blindly assigned to each concentration group sequentially. Participants will undergo ICG fluorescence guided sentinel lymph node biopsy with the assigned solution formula. The endpoints included number of lymph nodes obtained, fluorescence signal-to-background ratio of the lymph nodes, lymphatic uptake rate, lymphatic drainage speed, detection method, lymph node pathology, and any intra- or post-operative complications.
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 |
|---|---|---|---|
| Breast Cancer Early Stage Breast Cancer (Stage 1-3) | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mannitol (20%) | Drug | — | UNRESOLVED |
| Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancer | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- ACTIVE_COMPARATOR
- label
- Pure Voluven
- description
- The solution is prepared using Voluven as solvent, forming a 0.25 mg/mL ICG:Voluven solution.
- interventionNames
- Procedure: Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancer
- type
- ACTIVE_COMPARATOR
- label
- 1:10
- description
- The solution is prepared using Mannitol(20%):Voluven=1:10 as solvent, forming a 0.25 mg/mL ICG:Solvent solution.
- interventionNames
- Procedure: Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancer
- Drug: Mannitol (20%)
- type
- ACTIVE_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Adult females aged 20 to 70 years old. * Pathologically confirmed invasive breast cancer patients who are eligible for sentinel lymph node biopsy. Exclusion Criteria: * History of allergy to iodine, ICG, blue dye, Voluven, or Mannitol. * History of hyperthyroidism, thyroid cancer, etc. * Current pregnancy, lactation, or breast infection. * Individuals with impaired mental capacity or belonging to vulnerable populations. * Patients who have undergone neoadjuvant chemotherapy prior to surgery.
References
Publications (1)
- BACKGROUNDHsieh YC, Guo KW, Wang MW, Su SP, Syu YH, Huang CS, Chan YH. A Novel Injection Protocol Using Voluven(R)-Assisted Indocyanine Green with Improved Near-Infrared Fluorescence Guidance in Breast Cancer Sentinel Lymph Node Mapping-A Translational Study. Ann Surg Oncol. 2023 Dec;30(13):8419-8427. doi: 10.1245/s10434-023-14129-4. Epub 2023 Aug 21. PMID 37605084