Breast CancerUHFUSNCT07677839
UHFUS Characterization of Normal Lymphatic Anatomy
A study testing Indocyanine green (ICG) solution injection and Ultra-High Frequency Ultrasound in people with Breast Cancer, run by University of California, Davis at 1 site in United States.
Trial summary
This is a prospective pilot study of breast cancer patients undergoing axillary lymph node dissection (ALND) or sentinel lymph node biopsy (SLNB). Participants will undergo ultra-high frequency ultrasound (UHFUS) imaging with indocyanine green (ICG) dye to map lymphatic channels between the wrist and elbow to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Indocyanine green (ICG) solution injection and Ultra-High Frequency Ultrasound
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2026to 1 Sep 2036
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Aged 18+ at the time of consent.
- 2. Confirmed breast cancer diagnosis
- 3. Planned ALND (CPT code: 38745) or SLNB (CPT code: 38900) for breast cancer treatment
- 4. Provision of a signed and dated informed consent form.
- 5. Stated willingness to comply with all study procedures and availability for the duration of the study.
Who cannot join
- 1. History of transient or permanent edema of the extremity, including edema ≥stage 1 per the International Society of Lymphology (ISL) staging system 15
- 2. History of prior axillary nodal surgery
- 3. History of any lymphatic disease or venous disease of the upper extremity, including deep venous thrombosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California Davis Health
Sacramento, California, 95816
Shari Nichols, (916) 734-7289, slnichols@health.ucdavis.edu
Ara Salibian, MD
About this study
Official title: Redefining the Normal: Ultra-High Frequency Ultrasound Characterization of Lymphatic Anatomy in Patients With Breast Cancer
This is a prospective pilot study of breast cancer patients undergoing axillary lymph node dissection (ALND) or sentinel lymph node biopsy (SLNB). Participants will undergo ultra-high frequency ultrasound (UHFUS) imaging with indocyanine green (ICG) dye to map lymphatic channels between the wrist and elbow to investigate normal lymphatic anatomy in patients with breast cancer.
Read the detailed description
This is a prospective pilot study of breast cancer patients undergoing axillary lymph node dissection (ALND) or sentinel lymph node biopsy (SLNB). Participants will undergo ultra-high frequency ultrasound (UHFUS) imaging with indocyanine green (ICG) dye to map lymphatic channels between the wrist and elbow to investigate normal lymphatic anatomy in patients with breast cancer. Additionally, the study will evaluate the adverse reactions to indocyanine green (ICG) dye, characterize variability in ultrasonographic characteristics of lymphatic channels, investigate the correlation of indocyanine green (ICG) pathways and UHFUS characteristics of lymphatic channels, and investigate the correlation of ICG lymphography patterns and patient demographics.
The primary study objective is to investigate normal lymphatic anatomy in patients with breast cancer using UHFUS. We hypothesize that normal lymphatic anatomy exhibits consistent ultrasonographic characteristics, and ICG lymphography can reliably correlate with UHFUS findings.
- Conditions
- Breast Cancer
- Being tested
- Indocyanine green (ICG) solution injection, Ultra-High Frequency Ultrasound
- Keywords
- Breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine green (ICG) solution injectionProcedure or surgery
Also called IC-Green
0.1cc of 2.5 mg/cc Indocyanine green (ICG) solution will be injected intradermally at the 1st and 4th webspaces of the hand, and radial and ulnar volar wrist areas.
Ultra-High Frequency UltrasoundDevice
UHFUS will capture still images at specific landmarks along the wrist-to-elbow axis to characterize lymphatic channels. The following quantitative data of lymphatic channels will be captured:
- Outer diameter (i.e., total diameter including wall and lumen); 2. Inner diameter (i.e., diameter of the lumen only); and 3. Wall thickness (i.e., the thickness of the lymphatic channel wall)
| Study group | Role | What they receive |
|---|---|---|
| Ultra-high frequency ultrasound (UHFUS) imaging with indocyanine green (ICG) dye | Experimental | Indocyanine green (ICG) solution will be injected intradermally, followed by ultra-high-frequency ultrasound imaging/mapping to characterize lymphatic channels. Receives: Procedure: Indocyanine green (ICG) solution injection; Device: Ultra-High Frequency Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outer lymphatic vessel diameter
Total diameter including wall and lumen
Measured: During ultra-high frequency ultrasound imaging
Secondary outcomes (11)
Vessel wall thickness
Vessel thickness will be measured using the 70Mhz probe
Measured: During ultra-high frequency ultrasound imaging
Degree of sclerosis
Degree of sclerosis will be measured according to Bianchi et al (PMID: 32591265) as a Type I (ectatic, no wall sclerosis on ultrasound ) versus type (constricted, positive hyperechoic wall sclerosis on ultrasound) classification
Measured: During ultra-high frequency ultrasound imaging
Number of lymphatic channels
Number of lymphatic channels on ultrasound per linear indocyanine green angiography line will be measured
Measured: During ultra-high frequency ultrasound imaging
Channel confluence points
Confluence points will be categorized by the number of vessels that join in a signal ultrasound zone. This will first be a binary Yes or No outcome. If yes, then they will be categorized 2:1 for two vessels joining to one or 3:1 for three vessels joining to one.
Measured: During ultra-high frequency ultrasound imaging
Incidence of allergic or anaphylactic reactions, including rash, pruritus, hypotension, or respiratory distress.
Severity and frequency will be documented using the Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 (specific for cancer patients).
Measured: From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge.
Incidence of injection site reactions
Including pain, swelling, redness, or infection at injection sites
Measured: From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge.
Duration of injection site reactions
Length of duration of any injection site reaction
Measured: From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge.
Required interventions (e.g., antibiotics) for injection site reactions
Any required intervention for an injection site reaction
Measured: From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge.
Quantification of the lymphatic channels identified/ visualized along linear ICG patterns
Number of lymphatic channels visualized per ICG line
Measured: During ultra-high frequency ultrasound imaging
Identification of anatomical locations where lymphatic channels merge or narrow (i.e., channel confluence and constriction)
Number of lymphatic channels on ultrasound that merge with each other or separate per ultrasound zone
Measured: During ultra-high frequency ultrasound imaging
correlation of ICG lymphography patterns and patient demographics
Including body mass index, handedness (left/right dominant hand), and comorbidities (e.g., diabetes, hypertension, other chronic illnesses)
Measured: During ultra-high frequency ultrasound imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start17 Jun 2026
- Primary completion1 Mar 2036 (estimated)
- Study completion1 Sep 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive an indocyanine green (ICG) solution injection, followed by ultra-high frequency ultrasound imaging/ mapping
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ara Salibian MD, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677839
- Sponsor's protocol ID
- 2287319-1
- Acronym
- UHFUS
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared due to the inclusion of sensitive health information and standardized photographs that cannot be fully de-identified. Data will be used solely for this study in accordance with UC Davis IRB approval.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Redefining the Normal: Ultra-High Frequency Ultrasound Characterization of Lymphatic Anatomy in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT07677839
- Acronym / sponsor ID
- UHFUS / 2287319-1
- Conditions
- Breast Cancer
- Keywords
- Breast cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 17 Jun 2026 (actual)
- Primary completion
- 1 Mar 2036 (estimated)
- Study completion
- 1 Sep 2036 (estimated)
- First posted
- 1 Jul 2026 (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.
This is a prospective pilot study of breast cancer patients undergoing axillary lymph node dissection (ALND) or sentinel lymph node biopsy (SLNB). Participants will undergo ultra-high frequency ultrasound (UHFUS) imaging with indocyanine green (ICG) dye to map lymphatic channels between the wrist and elbow to investigate normal lymphatic anatomy in patients with breast cancer.
Detailed description
This is a prospective pilot study of breast cancer patients undergoing axillary lymph node dissection (ALND) or sentinel lymph node biopsy (SLNB). Participants will undergo ultra-high frequency ultrasound (UHFUS) imaging with indocyanine green (ICG) dye to map lymphatic channels between the wrist and elbow to investigate normal lymphatic anatomy in patients with breast cancer. Additionally, the study will evaluate the adverse reactions to indocyanine green (ICG) dye, characterize variability in ultrasonographic characteristics of lymphatic channels, investigate the correlation of indocyanine green (ICG) pathways and UHFUS characteristics of lymphatic channels, and investigate the correlation of ICG lymphography patterns and patient demographics.
The primary study objective is to investigate normal lymphatic anatomy in patients with breast cancer using UHFUS. We hypothesize that normal lymphatic anatomy exhibits consistent ultrasonographic characteristics, and ICG lymphography can reliably correlate with UHFUS findings.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive an indocyanine green (ICG) solution injection, followed by ultra-high frequency ultrasound imaging/ mapping
| Arm | Type | Receives |
|---|---|---|
| Ultra-high frequency ultrasound (UHFUS) imaging with indocyanine green (ICG) dye | Experimental | Procedure: Indocyanine green (ICG) solution injection, Device: Ultra-High Frequency UltrasoundIndocyanine green (ICG) solution will be injected intradermally, followed by ultra-high-frequency ultrasound imaging/mapping to characterize lymphatic channels. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Aged 18+ at the time of consent.
- 2. Confirmed breast cancer diagnosis
- 3. Planned ALND (CPT code: 38745) or SLNB (CPT code: 38900) for breast cancer treatment
- 4. Provision of a signed and dated informed consent form.
- 5. Stated willingness to comply with all study procedures and availability for the duration of the study.
Key exclusion criteria (3 listed)
- 1. History of transient or permanent edema of the extremity, including edema ≥stage 1 per the International Society of Lymphology (ISL) staging system 15
- 2. History of prior axillary nodal surgery
- 3. History of any lymphatic disease or venous disease of the upper extremity, including deep venous thrombosis
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 |
|---|---|---|
| Indocyanine green (ICG) solution injectionAlso: IC-Green0.1cc of 2.5 mg/cc Indocyanine green (ICG) solution will be injected intradermally at the 1st and 4th webspaces of the hand, and radial and ulnar volar wrist areas. | Procedure or surgery | Ultra-high frequency ultrasound (UHFUS) imaging with indocyanine green (ICG) dye |
| Ultra-High Frequency UltrasoundUHFUS will capture still images at specific landmarks along the wrist-to-elbow axis to characterize lymphatic channels. The following quantitative data of lymphatic channels will be captured: 1. Outer diameter (i.e., total diameter including wall and lumen); 2. Inner diameter (i.e., diameter of the lumen only); and 3. Wall thickness (i.e., the thickness of the lymphatic channel wall) | Device | Ultra-high frequency ultrasound (UHFUS) imaging with indocyanine green (ICG) dye |
Primary outcome
Outer lymphatic vessel diameter
Time frame: During ultra-high frequency ultrasound imaging
Total diameter including wall and lumen
11 secondary outcomes
Vessel wall thickness
Time frame: During ultra-high frequency ultrasound imaging
Degree of sclerosis
Time frame: During ultra-high frequency ultrasound imaging
Number of lymphatic channels
Time frame: During ultra-high frequency ultrasound imaging
Channel confluence points
Time frame: During ultra-high frequency ultrasound imaging
Incidence of allergic or anaphylactic reactions, including rash, pruritus, hypotension, or respiratory distress.
Time frame: From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge.
Incidence of injection site reactions
Time frame: From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge.
Duration of injection site reactions
Time frame: From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge.
Required interventions (e.g., antibiotics) for injection site reactions
Time frame: From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge.
Quantification of the lymphatic channels identified/ visualized along linear ICG patterns
Time frame: During ultra-high frequency ultrasound imaging
Identification of anatomical locations where lymphatic channels merge or narrow (i.e., channel confluence and constriction)
Time frame: During ultra-high frequency ultrasound imaging
correlation of ICG lymphography patterns and patient demographics
Time frame: During ultra-high frequency ultrasound imaging
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 1 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to the inclusion of sensitive health information and standardized photographs that cannot be fully de-identified. Data will be used solely for this study in accordance with UC Davis IRB approval.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indocyanine green (ICG) solution injection and Ultra-High Frequency Ultrasound in people with Breast Cancer, run by University of California, Davis at 1 site in United States.
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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 1 Jul 2026. 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 United States. 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.
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?
Contact Sheri Nichols ((916) 734-7289, slnichols@health.ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outer lymphatic vessel diameter (time frame: During ultra-high frequency ultrasound imaging). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2026.