Breast Cancer Early Stage Breast Cancer (Stage 1-3)Phase 1/2ICGMVNCT06768268
A Dose-Image Optimization Trial Evaluating Mannitol and Voluven as Adjuncts for Indocyanine Green
A Phase 1/2 study testing Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancer and Mannitol (20%) in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- What is being tested?
- Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancer and Mannitol (20%)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2025to 31 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult females aged 20 to 70 years old.
- Pathologically confirmed invasive breast cancer patients who are eligible for sentinel lymph node biopsy.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
National Taiwan University Hospital Hsinchu Branch
Hsinchu County, 302
About this study
Official title: Advanced Research on ICG Fluorescence Imaging-Guided Surgery Technique Using Mannitol and Voluven as Adjuncts
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?
Read more
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.
- Being tested
- Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancer, Mannitol (20%)
- Keywords
- indocyanine green, sentinel lymph node biopsy, near-infrared fluorescence, 6-hydroxyethyl starch, mannitol, breast cancer, fluorescence-guided surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancerProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Pure Voluven | Active comparator | The solution is prepared using Voluven as solvent, forming a 0.25 mg/mL ICG:Voluven solution. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancer; Drug: Mannitol (20%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of sentinel lymph nodes
The number of the retrieved sentinel lymph nodes
Measured: From the procedure day to the follow-up clinic visit day (average 10 days)
Fluorescence signal-to-background ratio of the lymph nodes
Measured: From the procedure day to the follow-up clinic visit day (average 10 days)
Secondary outcomes (4)
Lymphatic uptake rate
The time from injection to the development of fluorescent subcutaneous lymphatics
Measured: From the procedure day to the follow-up clinic visit day (average 10 days)
Lymphatic drainage speed
The time from the initiation of visible fluorescent subcutaneous lymphatics to that reaches the axilla
Measured: From the procedure day to the follow-up clinic visit day (average 10 days)
Detection method
The method of the sentinel lymph node being detected. (Could be radioisotope, blye dye, ICG fluorescence, or combination of multiple methods)
Measured: From the procedure day to the follow-up clinic visit day (average 10 days)
Lymph node pathology
The positivity of sentinel lymph node metastasis in the pathology report.
Measured: From the procedure day to the follow-up clinic visit day (average 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start1 Jan 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer Early Stage Breast Cancer (Stage 1-3)Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Yang Ming Chiao Tung University, National Taiwan University Hospital Hsin-Chu Branch
- Responsible party
- Sponsor
- Investigators
- Yung Chun Hsieh, M.D., MMSC, Study chair, National Taiwan University Hospital Hsinchu Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768268
- Sponsor's protocol ID
- 202409024MIND
- Other IDs
- 114-BIH052
- Acronym
- ICGMV
- Status last verified
- Dec 2024
- First submitted
- 29 Dec 2024
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37605084
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Research on ICG Fluorescence Imaging-Guided Surgery Technique Using Mannitol and Voluven as Adjuncts
- ClinicalTrials.gov ID
- NCT06768268
- Acronym / sponsor ID
- ICGMV / 202409024MIND
- Keywords
- indocyanine green, sentinel lymph node biopsy, near-infrared fluorescence, 6-hydroxyethyl starch, mannitol, breast cancer, fluorescence-guided surgery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Yang Ming Chiao Tung University, National Taiwan University Hospital Hsin-Chu Branch
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 5
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pure Voluven | Active comparator | Procedure: Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancerThe solution is prepared using Voluven as solvent, forming a 0.25 mg/mL ICG:Voluven solution. |
| 1:10 | Active comparator | Procedure: Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancer, Drug: 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 | Active comparator | Procedure: Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancer, Drug: 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 | Active comparator | Procedure: Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancer, Drug: 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 | Active comparator | Procedure: Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancer, Drug: Mannitol (20%)The solution is prepared using Mannitol(20%):Voluven=1:4 as solvent, forming a 0.25 mg/mL ICG:Solvent solution. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult females aged 20 to 70 years old.
- Pathologically confirmed invasive breast cancer patients who are eligible for sentinel lymph node biopsy.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancerThe 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 | Procedure or surgery | 1:10, 1:4, 1:6, 1:8, Pure Voluven |
| Mannitol (20%)Adding Mannitol into Voluven and used as solvent of ICG | Drug | 1:10, 1:4, 1:6, 1:8 |
Primary outcome
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
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)
4 secondary outcomes
Lymphatic uptake rate
Time frame: From the procedure day to the follow-up clinic visit day (average 10 days)
Lymphatic drainage speed
Time frame: From the procedure day to the follow-up clinic visit day (average 10 days)
Detection method
Time frame: From the procedure day to the follow-up clinic visit day (average 10 days)
Lymph node pathology
Time frame: From the procedure day to the follow-up clinic visit day (average 10 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Background: PubMed 37605084Hsieh 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yung Chun Hsieh, M.D., MMSC study chair
National Taiwan University Hospital Hsinchu Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancer and Mannitol (20%) in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of sentinel lymph nodes (time frame: From the procedure day to the follow-up clinic visit day (average 10 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06768268, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.