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

National Taiwan University

Status and phase: Invitation-only; Phase 2; Phase 1

Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Treatments: Drug: Mannitol (20%); Procedure: Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancer

Study type: Interventional

Funder types: Other

Identifiers

NCT06768268

202409024MIND

114-BIH052 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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30 participants in 5 patient groups

Pure Voluven

Active Comparator group

Description:

The solution is prepared using Voluven as solvent, forming a 0.25 mg/mL ICG:Voluven solution.

Treatment:

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

1:10

Active Comparator group

Description:

The solution is prepared using Mannitol(20%):Voluven=1:10 as solvent, forming a 0.25 mg/mL ICG:Solvent solution.

Treatment:

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

Drug: Mannitol (20%)

1:8

Active Comparator group

Description:

The solution is prepared using Mannitol(20%):Voluven=1:8 as solvent, forming a 0.25 mg/mL ICG:Solvent solution.

Treatment:

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

Drug: Mannitol (20%)

1:6

Active Comparator group

Description:

The solution is prepared using Mannitol(20%):Voluven=1:6 as solvent, forming a 0.25 mg/mL ICG:Solvent solution.

Treatment:

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

Drug: Mannitol (20%)

1:4

Active Comparator group

Description:

The solution is prepared using Mannitol(20%):Voluven=1:4 as solvent, forming a 0.25 mg/mL ICG:Solvent solution.

Treatment:

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

Drug: Mannitol (20%)