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

NCT06768268 | Enrolling By Invitation Phase 1

• 2 other identifiers: 202409024MIND114-BIH052
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Keywords

indocyanine green; sentinel lymph node biopsy; near-infrared fluorescence; 6-hydroxyethyl starch; mannitol; breast cancer; fluorescence-guided surgery

Outcome Measures

Primary Outcomes (2)

• Number of sentinel lymph nodes

  The number of the retrieved sentinel lymph nodes

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

• Fluorescence signal-to-background ratio of the lymph nodes

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

Secondary Outcomes (4)

• Lymphatic uptake rate

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

• Lymphatic drainage speed

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

• Detection method

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

• Lymph node pathology

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

Study Arms (5)

Pure Voluven

ACTIVE COMPARATOR

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

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

1:10

ACTIVE COMPARATOR

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

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

1:8

ACTIVE COMPARATOR

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

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

1:6

ACTIVE COMPARATOR

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

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

1:4

ACTIVE COMPARATOR

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

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

Interventions

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

1:10; 1:4; 1:6; 1:8; Pure Voluven

Mannitol (20%) DRUG

Adding Mannitol into Voluven and used as solvent of ICG

1:10; 1:4; 1:6; 1:8

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult females aged 20 to 70 years old.
• Pathologically confirmed invasive breast cancer patients who are eligible for sentinel lymph node biopsy.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

National Taiwan University Hospital Hsinchu Branch

Hsinchu County, 302, Taiwan

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mannitol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Yung Chun Hsieh, M.D., MMSC

  National Taiwan University Hospital Hsinchu Branch

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will not know which concentration group they are assigned to.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a dose-escalation trial of adding Mannitol into Voluven-ICG solution as solvent/adjunct. The patients will be invited in groups of three, and the proportion of Mannitol will be escalated in the sequential groups.

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: January 10, 2025
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 16, 2025

Record last verified: 2024-12

Locations

TW (1)