Clinical trial NCT06768268: A Dose-Image Optimization Trial Evaluating Mannitol and Voluven as Adjuncts for Indocyanine Green
Official title: Advanced Research on ICG Fluorescence Imaging-Guided Surgery Technique Using Mannitol and Voluven as Adjuncts
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
PHASE2
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
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Yang Ming Chiao Tung University
name: National Taiwan University Hospital Hsin-Chu Branch
First posted: 2025-01-10
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Number of sentinel lymph nodes
timeFrame: From the procedure day to the follow-up clinic visit day (average 10 days)
measure: Fluorescence signal-to-background ratio of the lymph nodes
timeFrame: From the procedure day to the follow-up clinic visit day (average 10 days)
Secondary outcomes:
measure: Lymphatic uptake rate
timeFrame: From the procedure day to the follow-up clinic visit day (average 10 days)
measure: Lymphatic drainage speed
timeFrame: From the procedure day to the follow-up clinic visit day (average 10 days)
measure: Detection method
timeFrame: From the procedure day to the follow-up clinic visit day (average 10 days)
measure: Lymph node pathology
timeFrame: From the procedure day to the follow-up clinic visit day (average 10 days)
Other outcomes:
Locations:
city: Hsinchu County
country: Taiwan
facility: National Taiwan University Hospital Hsinchu Branch
Study officials:
affiliation: National Taiwan University Hospital Hsinchu Branch
name: Yung Chun Hsieh, M.D., MMSC
role: STUDY_CHAIR
References:
citation: 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.