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Enrolling by invitation NCT06768268

A Dose-Image Optimization Trial Evaluating Mannitol and Voluven as Adjuncts for Indocyanine Green

Phase I / Phase II Interventional Breast Cancer Early Stage Breast Cancer (Stage 1-3)

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancer, Mannitol (20%).
Who it may be relevant to
Registry conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3). Basic parameters: 20 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Advanced Research on ICG Fluorescence Imaging-Guided Surgery Technique Using Mannitol and Voluven as Adjuncts

Overview

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.

Interventions

  • Procedure Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancer
    The procedure includes: (1) preparation of specific formula of ICG:Voluven solution (2) injection of ICG solution at subarelar area or peri-tumoral area (3) observation of fluorescent lymphatic drainage and retrieval of sentinel lymph nodes
  • Drug Mannitol (20%)
    Adding Mannitol into Voluven and used as solvent of ICG

Primary outcome measures

  • Number of sentinel lymph nodes [Time frame: From the procedure day to the follow-up clinic visit day (average 10 days)]
  • Fluorescence signal-to-background ratio of the lymph nodes [Time frame: From the procedure day to the follow-up clinic visit day (average 10 days)]
Secondary outcome measures (4)
  • Lymphatic uptake rate [Time frame: From the procedure day to the follow-up clinic visit day (average 10 days)]
  • Lymphatic drainage speed [Time frame: From the procedure day to the follow-up clinic visit day (average 10 days)]
  • Detection method [Time frame: From the procedure day to the follow-up clinic visit day (average 10 days)]
  • Lymph node pathology [Time frame: From the procedure day to the follow-up clinic visit day (average 10 days)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Single blind
Primary purpose
Other

Study locations

Taiwan · 1 center
  • National Taiwan University Hospital Hsinchu Branch — Hsinchu County

Publications

  • Hsieh 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

Identifiers

NCT: NCT06768268 · 202409024MIND · 114-BIH052

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗