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NCT Number: NCT06768268

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

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.

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Key information

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3) Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

National Taiwan University Hospital Hsinchu Branch

Hsinchu County, 302, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancer

Procedure

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

Mannitol (20%)

Drug

Adding Mannitol into Voluven and used as solvent of ICG

Primary outcomes

  1. Number of sentinel lymph nodes

    Time frame: From the procedure day to the follow-up clinic visit day (average 10 days)

    The number of the retrieved sentinel lymph nodes

  2. 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 outcomes

  1. Lymphatic uptake rate

    Time frame: From the procedure day to the follow-up clinic visit day (average 10 days)

    The time from injection to the development of fluorescent subcutaneous lymphatics

  2. Lymphatic drainage speed

    Time frame: From the procedure day to the follow-up clinic visit day (average 10 days)

    The time from the initiation of visible fluorescent subcutaneous lymphatics to that reaches the axilla

  3. Detection method

    Time frame: From the procedure day to the follow-up clinic visit day (average 10 days)

    The method of the sentinel lymph node being detected. (Could be radioisotope, blye dye, ICG fluorescence, or combination of multiple methods)

  4. Lymph node pathology

    Time frame: From the procedure day to the follow-up clinic visit day (average 10 days)

    The positivity of sentinel lymph node metastasis in the pathology report.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • National Taiwan University Hospital Hsin-Chu Branch
  • National Yang Ming Chiao Tung University

Registry information

Official study title

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

Acronym: ICGMV

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 10, 2025
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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