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

Phase 1

• Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)
• Interventions: Procedure: Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancer; Drug: Mannitol (20%)

• Registration Number: NCT06768268
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-29
• Study Start: 2025-01-01
• Study First Submitted QC: 2025-01-06
• Last Update Submitted: 2025-01-06
• Study First Posted: 2025-01-10
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Pure Voluven	Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancer	The solution is prepared using Voluven as solvent, forming a 0.25 mg/mL ICG:Voluven solution.
1:10	Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancer	The solution is prepared using Mannitol(20%):Voluven=1:10 as solvent, forming a 0.25 mg/mL ICG:Solvent solution.
1:10	Mannitol (20%)	The solution is prepared using Mannitol(20%):Voluven=1:10 as solvent, forming a 0.25 mg/mL ICG:Solvent solution.
1:8	Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancer	The solution is prepared using Mannitol(20%):Voluven=1:8 as solvent, forming a 0.25 mg/mL ICG:Solvent solution.
1:8	Mannitol (20%)	The solution is prepared using Mannitol(20%):Voluven=1:8 as solvent, forming a 0.25 mg/mL ICG:Solvent solution.
1:6	Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancer	The solution is prepared using Mannitol(20%):Voluven=1:6 as solvent, forming a 0.25 mg/mL ICG:Solvent solution.
1:6	Mannitol (20%)	The solution is prepared using Mannitol(20%):Voluven=1:6 as solvent, forming a 0.25 mg/mL ICG:Solvent solution.
1:4	Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancer	The solution is prepared using Mannitol(20%):Voluven=1:4 as solvent, forming a 0.25 mg/mL ICG:Solvent solution.
1:4	Mannitol (20%)	The solution is prepared using Mannitol(20%):Voluven=1:4 as solvent, forming a 0.25 mg/mL ICG:Solvent solution.

Primary Outcome Measures

Name	Time	Method
Number of sentinel lymph nodes	From the procedure day to the follow-up clinic visit day (average 10 days)	The number of the retrieved sentinel lymph nodes
Fluorescence signal-to-background ratio of the lymph nodes	From the procedure day to the follow-up clinic visit day (average 10 days)

Secondary Outcome Measures

Name	Time	Method
Lymphatic drainage speed	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
Lymphatic uptake rate	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
Detection method	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)
Lymph node pathology	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.

Trial Locations

Locations (1)

National Taiwan University Hospital Hsinchu Branch; 🇨🇳 Hsinchu County, Taiwan