Breast CancerPhase 1NCT05365204
A Study for Optimization of 6% Hydroxyethyl Starch Based Indocyanine Green Near-infrared Fluorescence Navigated Sentinel Lymph Node Biopsy for Breast Cancer Patients
A Phase 1 study testing Near infrared fluorescence navigated sentinel lymph node mapping in people with Breast Cancer and Sentinel Lymph Node, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
Trial summary
A study for dosage-image optimization of 6% hydroxyethyl starch diluted indocyanine green for near-infrared fluorescence navigated sentinel lymph node mapping for breast cancer patient. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Breast Cancer, Sentinel Lymph Node
- What is being tested?
- Near infrared fluorescence navigated sentinel lymph node mapping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Apr 2022to 7 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer, adults
Who cannot join
- Patient aged < 20 years old
- Primary lesion without indication of sentinel lymph node biopsy in current guidelines (Low-risk ductal carcinoma in situ or metastatic breast cancer)
- Patient who is allergic to primary tracers (including Tc99m and blue dye)
- Patient who is allergic to indocyanine green
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital Hsin-Chu Branch Biomedical Park Hospital
Zhubei, HsinChu County, 302
Yung-Chun Hsieh, MD, +886-972322925, abitzsong@gmail.com
About this study
A study for dosage-image optimization of 6% hydroxyethyl starch diluted indocyanine green for near-infrared fluorescence navigated sentinel lymph node mapping for breast cancer patient.
Read the detailed description
Pre-clinical experiment has shown using 6% hydroxyethyl starch (Voluven®) as a solvent, compared with pure water, can improve brightness of indocyanine green particles at the same concentration. Similar findings have been addressed using human serum albumin as a solvent for indocyanine green in previous studies, but there was no report using 6% hydroxyethyl starch as a solvent till now. This study aims for clinical translation and optimization of 6% hydroxyethyl starch diluted indocyanine green in breast cancer patients undergoing sentinel lymph node biopsy.
- Conditions
- Breast Cancer, Sentinel Lymph Node
- Being tested
- Near infrared fluorescence navigated sentinel lymph node mapping
- Keywords
- Indocyanine green, Sentinel lymph node biopsy, Axillary lymph node dissection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near infrared fluorescence navigated sentinel lymph node mappingProcedure or surgery
Patient will undergo sentinel lymph node biopsy with near infrared fluorescence navigation. The dosage of ICG will not exceed 2.5 mg in total, and the volume of the assigned solvent will not exceed 5 mL in total.
| Study group | Role | What they receive |
|---|---|---|
| Voluven diluted indocyanine green | Experimental | This arm participants uses Voluven diluted ICG for sentinel lymph node mapping. Receives: Procedure: Near infrared fluorescence navigated sentinel lymph node mapping |
| Distilled-water diluted indocyanine green | Active comparator | This arm participants uses Distilled-water diluted ICG for sentinel lymph node mapping. Receives: Procedure: Near infrared fluorescence navigated sentinel lymph node mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signal-to-background ratio (SBR)
Evaluates the SBR of the near-infrared fluorescence between the retrieved sentinel lymph nodes and the background.
Measured: through study completion, an average of 1 year
Penetration depth
Evaluates the depth of the deepest visualized subcutaneous lymphatics in the breast
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Sentinel lymph nodes pathology
The positivity and number of retrieved sentinel lymph nodes at definitive pathology report.
Measured: through study completion, an average of 1 year
Time to total visualization of breast subcutaneous lymphatics
The time from injection of indocyanine green to total visualization of breast subcutaneous lymphatics
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start8 Apr 2022
- Primary completion7 Apr 2023 (estimated)
- Study completion7 Apr 2023 (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 CancerStudies of the same condition, open and under way.
- 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants will be assigned to sentinel lymph node biopsies using different concentrations of voluven based indocyanine green. Estimated concentration grouping (ICG mg / Voluven mL): 2.5, 0.5, 0.25, 0.125, 0.0625. Planned recruiting at least 3 participants in each diluted concentration group. The dilution rate will advance if imaging quality is improving compared with the last concentration group. The study will be completed if the best imaging quality injection protocol is found.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu Branch
- Sponsor type
- University, hospital or other
- Collaborators
- National Yang Ming Chiao Tung University
- Responsible party
- Sponsor
- Investigators
- Yung-Chun Hsieh, MD, Study chair, National Taiwan University Hospital Hsin-Chu Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365204
- Sponsor's protocol ID
- 111-009-F
- Status last verified
- May 2022
- First submitted
- 27 Apr 2022
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mieog JS, Troyan SL, Hutteman M, Donohoe KJ, van der Vorst JR, Stockdale A, Liefers GJ, Choi HS, Gibbs-Strauss SL, Putter H, Gioux S, Kuppen PJ, Ashitate Y, Lowik CW, Smit VT, Oketokoun R, Ngo LH, van de Velde CJ, Frangioni JV, Vahrmeijer AL. Toward optimization of imaging system and lymphatic tracer for near-infrared fluorescent sentinel lymph node mapping in breast cancer. Ann Surg Oncol. 2011 Sep;18(9):2483-91. doi: 10.1245/s10434-011-1566-x. Epub 2011 Mar 1.
PubMed 21360250
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study for Optimization of 6% Hydroxyethyl Starch Based Indocyanine Green Near-infrared Fluorescence Navigated Sentinel Lymph Node Biopsy for Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05365204
- Acronym / sponsor ID
- 111-009-F
- Conditions
- Breast Cancer, Sentinel Lymph Node
- Keywords
- Indocyanine green, Sentinel lymph node biopsy, Axillary lymph node dissection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu BranchUniversity, hospital or other
- Collaborators
- National Yang Ming Chiao Tung University
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- 7 Apr 2023 (estimated)
- Study completion
- 7 Apr 2023 (estimated)
- First posted
- 9 May 2022 (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.
A study for dosage-image optimization of 6% hydroxyethyl starch diluted indocyanine green for near-infrared fluorescence navigated sentinel lymph node mapping for breast cancer patient.
Detailed description
Pre-clinical experiment has shown using 6% hydroxyethyl starch (Voluven®) as a solvent, compared with pure water, can improve brightness of indocyanine green particles at the same concentration. Similar findings have been addressed using human serum albumin as a solvent for indocyanine green in previous studies, but there was no report using 6% hydroxyethyl starch as a solvent till now. This study aims for clinical translation and optimization of 6% hydroxyethyl starch diluted indocyanine green in breast cancer patients undergoing sentinel lymph node biopsy.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The participants will be assigned to sentinel lymph node biopsies using different concentrations of voluven based indocyanine green. Estimated concentration grouping (ICG mg / Voluven mL): 2.5, 0.5, 0.25, 0.125, 0.0625. Planned recruiting at least 3 participants in each diluted concentration group. The dilution rate will advance if imaging quality is improving compared with the last concentration group. The study will be completed if the best imaging quality injection protocol is found.
| Arm | Type | Receives |
|---|---|---|
| Voluven diluted indocyanine green | Experimental | Procedure: Near infrared fluorescence navigated sentinel lymph node mappingThis arm participants uses Voluven diluted ICG for sentinel lymph node mapping. |
| Distilled-water diluted indocyanine green | Active comparator | Procedure: Near infrared fluorescence navigated sentinel lymph node mappingThis arm participants uses Distilled-water diluted ICG for sentinel lymph node mapping. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Breast cancer, adults
Key exclusion criteria (4 listed)
- Patient aged < 20 years old
- Primary lesion without indication of sentinel lymph node biopsy in current guidelines (Low-risk ductal carcinoma in situ or metastatic breast cancer)
- Patient who is allergic to primary tracers (including Tc99m and blue dye)
- Patient who is allergic to indocyanine green
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 |
|---|---|---|
| Near infrared fluorescence navigated sentinel lymph node mappingPatient will undergo sentinel lymph node biopsy with near infrared fluorescence navigation. The dosage of ICG will not exceed 2.5 mg in total, and the volume of the assigned solvent will not exceed 5 mL in total. | Procedure or surgery | Distilled-water diluted indocyanine green, Voluven diluted indocyanine green |
Primary outcome
Signal-to-background ratio (SBR)
Time frame: through study completion, an average of 1 year
Evaluates the SBR of the near-infrared fluorescence between the retrieved sentinel lymph nodes and the background.
Penetration depth
Time frame: through study completion, an average of 1 year
Evaluates the depth of the deepest visualized subcutaneous lymphatics in the breast
2 secondary outcomes
Sentinel lymph nodes pathology
Time frame: through study completion, an average of 1 year
Time to total visualization of breast subcutaneous lymphatics
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Background: PubMed 21360250Mieog JS, Troyan SL, Hutteman M, Donohoe KJ, van der Vorst JR, Stockdale A, Liefers GJ, Choi HS, Gibbs-Strauss SL, Putter H, Gioux S, Kuppen PJ, Ashitate Y, Lowik CW, Smit VT, Oketokoun R, Ngo LH, van de Velde CJ, Frangioni JV, Vahrmeijer AL. Toward optimization of imaging system and lymphatic tracer for near-infrared fluorescent sentinel lymph node mapping in breast cancer. Ann Surg Oncol. 2011 Sep;18(9):2483-91. doi: 10.1245/s10434-011-1566-x. Epub 2011 Mar 1.
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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. This study is not recruiting at the moment.
Yung-Chun Hsieh, MD study chair
National Taiwan University Hospital Hsin-Chu 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 study testing Near infrared fluorescence navigated sentinel lymph node mapping in people with Breast Cancer and Sentinel Lymph Node, run by National Taiwan University Hospital Hsin-Chu Branch 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 May 2022. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yung-Chun Hsieh, MD (+886-972322925, abitzsong@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signal-to-background ratio (SBR) (time frame: through study completion, an average of 1 year). 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 NCT05365204, 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 9 May 2022.