Breast CancerPhase 2NCT06327490
A Study Evaluating the Feasibility and Compliance of Manual Lymphatic Drainage Comparing Indocyanine-Green (ICG) Guided vs. Traditional Guided in Patients Undergoing Axillary Node Dissection for the Treatment of Breast Cancer
A Phase 2 study testing ICG-guided manual lymphatic drainage, Traditional manual lymphatic drainage and Indocyanine green in people with Breast Cancer, run by University of Florida at 1 site in United States.
Trial summary
Breast cancer is estimated to affect approximately 300,000 women in the US in 2023. Studies demonstrate that 1 in 5 will develop breast cancer related lymphedema secondary to the treatments that they receive. BCRL at this time has no cure, however early detection can prevent the progression to late stage BCRL. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- ICG-guided manual lymphatic drainage, Traditional manual lymphatic drainage and Indocyanine green
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2024to Jun 2028
- Phase
- Phase 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years of age
- Patients undergoing axillary lymph node dissection with or without lymphatic reconstruction at diagnosis
- Patients must have ICG lymphatic mapping performed prior to axillary lymph node dissection
- A clinical diagnosis consistent with stage Tis-T4N0-3M0 breast cancer.
- ECOG Performance Status of 0-1
- Subjects must not have more than one active malignancy at the time of enrollment (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen [as determined by the treating physician and approved by the PI] may be included).
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- Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.
- Subjects of childbearing potential (SOCBP) must have a negative pregnancy test prior to enrollment and be using an adequate method of contraception to avoid pregnancy throughout study participation to minimize the risk of pregnancy. Prior to study enrollment, subjects of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.
- Patients must undergo a baseline physical therapy evaluation prior to axillary lymph node dissection.
- Patients who have received neoadjuvant chemotherapy are required to see physical therapy for lymphedema assessment following completion of chemotherapy prior to surgery.
Who cannot join
- Patients with history of ipsilateral breast cancer (invasive or ductal carcinoma in situ (DCIS))
- Patients with history of prior ipsilateral axillary surgery, such as excisional biopsy of lymph nodes or treatment of benign axillary disease processes such as hidradenitis
- Patients with history of or concurrent diagnosis of contralateral breast cancer (bilateral breast cancer)
- Patients with planned contralateral axillary surgery or history of contralateral axillary surgery
- Patients with a history, or concurrent, malignancy of the ipsilateral upper extremity- i.e. skin cancer
- Patients with history of lymphedema or lymphatic dysmotility of the ipsilateral or contralateral arm or are found to have lymphatic dysfunction at their pre-operative visit
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- Patients with history of upper extremity blood clot, lymphangitis/cellulitis
- Patients with history of congestive heart failure or significant cardiac disease (such as New York Heart Association Class III or greater cardiac disease) including pacemakers incompatible for bioimpedance
- Patients with evidence of liver dysfunction including diagnosis of end stage liver disease
- Patients with less than 10 lymph nodes removed if no neoadjuvant chemotherapy (NAC) received, or less than 8 lymph nodes if NAC received. These node counts include nodes harvested as part of sentinel lymph node biopsy
- There is a lack of description of intraoperative findings during axillary lymph node dissection, such as the absence of notes on anatomy and procedure.
- Patients who are confirmed to be pregnant or breastfeeding.
- History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
- Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
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 Florida
Gainesville, Florida, 32610
Madeline Campellone, 352-273-5128, mcampellone@ufl.edu
Laura J Mallinson, (352) 265-5125, coppola@ufl.edu
About this study
Official title: A Pilot Study Evaluating the Feasibility and Compliance of Manual Lymphatic Drainage Comparing Indocyanine-Green (ICG) Guided vs. Traditional Guided in Patients Undergoing Axillary Node Dissection for the Treatment of Breast Cancer
Breast cancer is estimated to affect approximately 300,000 women in the US in 2023. Studies demonstrate that 1 in 5 will develop breast cancer related lymphedema secondary to the treatments that they receive. BCRL at this time has no cure, however early detection can prevent the progression to late stage BCRL. At this time a technique of arm massage, manual lymphatic drainage (MLD), is used for treatment. This study investigates a new method of MLD, which is guided by the individual patients' lymphatic anatomy through use of ICG-lymphography.
- Conditions
- Breast Cancer
- Being tested
- ICG-guided manual lymphatic drainage, Traditional manual lymphatic drainage, Indocyanine green
- Keywords
- breast cancer-related lymphedema, ICG-Lymphography Guided Manual Lymphatic Drainage, limb volume changes
- Medical subject headings
- Breast Neoplasms, Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG-guided manual lymphatic drainageProcedure or surgery
Participants will perform manual lymphatic drainage on their affected arm using ICG lymphography images of the lymphatic pathway in their affected arm as guidance once daily for 2 years post-surgery.
Traditional manual lymphatic drainageProcedure or surgery
Participants will perform manual lymphatic drainage on their affected arm using traditional technique once daily for 2 years post-surgery.
Indocyanine greenDrug
All participants will be injected with indocyanine green for lymphatic mapping of the affected upper extremity, however this mapping will only be used to guide manual lymphatic drainage for participants on the ICG-guided manual lymphatic drainage arm.
| Study group | Role | What they receive |
|---|---|---|
| ICG-guided manual lymphatic drainage | Experimental | Not described Receives: Procedure: ICG-guided manual lymphatic drainage; Drug: Indocyanine green |
| Traditional manual lymphatic drainage | Active comparator | Not described Receives: Procedure: Traditional manual lymphatic drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject compliance
Determine subject compliance rate with daily manual lymphatic drainage regimen. A subject is considered to be compliant if they perform manual lymphatic drainage at least 3 days/week.
Measured: 2 years
Secondary outcomes (5)
Relative volume change
Determine if patients undergoing ICG-guided MLD as compared to patients undergoing traditional MLD demonstrate reduced relative volume changes of the affected limb. The volume of the affected limb will be measured by circumferential limb measurements. These limb measurements will then be calculated into volume using conic geometry.
Measured: 2 years
Bioimpedance
Determine if patients undergoing ICG-guided MLD as compared to patients undergoing traditional MLD demonstrate lower rates of increased bioimpedance. Bioimpedance will be measured using both the sozo and in-body device methods.
Measured: 2 years
Breast cancer related lymphedema symptoms
Determine if patients undergoing ICG-guided MLD as compared to patients undergoing traditional MLD demonstrate lower rates of breast cancer related lymphedema symptoms. Breast cancer related lymphedema symptoms will be assessed by the Lymphedema Life Impact Scale questionnaire.
Measured: 2 years
Incidence of progression to late stage breast cancer related lymphedema
Compare the incidence of progression to late stage breast cancer related lymphedema in both arms
Measured: 2 years
Health-related quality of life
Compare health-related quality of life, as measured by the Lymphedema Life Impact Scale questionnaire, in both arms.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start15 Oct 2024
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (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.
- More trials run by University of FloridaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Spiguel, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327490
- Sponsor's protocol ID
- UF-BRE-012
- Other IDs
- IRB202400626, OCR44989
- Status last verified
- Feb 2026
- First submitted
- 18 Mar 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating the Feasibility and Compliance of Manual Lymphatic Drainage Comparing Indocyanine-Green (ICG) Guided vs. Traditional Guided in Patients Undergoing Axillary Node Dissection for the Treatment of Breast Cancer
- ClinicalTrials.gov ID
- NCT06327490
- Acronym / sponsor ID
- UF-BRE-012
- Conditions
- Breast Cancer
- Keywords
- breast cancer-related lymphedema, ICG-Lymphography Guided Manual Lymphatic Drainage, limb volume changes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 25 Mar 2024 (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.
Breast cancer is estimated to affect approximately 300,000 women in the US in 2023. Studies demonstrate that 1 in 5 will develop breast cancer related lymphedema secondary to the treatments that they receive. BCRL at this time has no cure, however early detection can prevent the progression to late stage BCRL. At this time a technique of arm massage, manual lymphatic drainage (MLD), is used for treatment. This study investigates a new method of MLD, which is guided by the individual patients' lymphatic anatomy through use of ICG-lymphography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICG-guided manual lymphatic drainage | Experimental | Procedure: ICG-guided manual lymphatic drainage, Drug: Indocyanine green |
| Traditional manual lymphatic drainage | Active comparator | Procedure: Traditional manual lymphatic drainage |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adults ≥ 18 years of age
- Patients undergoing axillary lymph node dissection with or without lymphatic reconstruction at diagnosis
- Patients must have ICG lymphatic mapping performed prior to axillary lymph node dissection
- A clinical diagnosis consistent with stage Tis-T4N0-3M0 breast cancer.
- ECOG Performance Status of 0-1
Key exclusion criteria (14 listed)
- Patients with history of ipsilateral breast cancer (invasive or ductal carcinoma in situ (DCIS))
- Patients with history of prior ipsilateral axillary surgery, such as excisional biopsy of lymph nodes or treatment of benign axillary disease processes such as hidradenitis
- Patients with history of or concurrent diagnosis of contralateral breast cancer (bilateral breast cancer)
- Patients with planned contralateral axillary surgery or history of contralateral axillary surgery
- Patients with a history, or concurrent, malignancy of the ipsilateral upper extremity- i.e. skin cancer
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 |
|---|---|---|
| ICG-guided manual lymphatic drainageParticipants will perform manual lymphatic drainage on their affected arm using ICG lymphography images of the lymphatic pathway in their affected arm as guidance once daily for 2 years post-surgery. | Procedure or surgery | ICG-guided manual lymphatic drainage |
| Traditional manual lymphatic drainageParticipants will perform manual lymphatic drainage on their affected arm using traditional technique once daily for 2 years post-surgery. | Procedure or surgery | Traditional manual lymphatic drainage |
| Indocyanine greenAll participants will be injected with indocyanine green for lymphatic mapping of the affected upper extremity, however this mapping will only be used to guide manual lymphatic drainage for participants on the ICG-guided manual lymphatic drainage arm. | Drug | ICG-guided manual lymphatic drainage |
Primary outcome
Subject compliance
Time frame: 2 years
Determine subject compliance rate with daily manual lymphatic drainage regimen. A subject is considered to be compliant if they perform manual lymphatic drainage at least 3 days/week.
5 secondary outcomes
Relative volume change
Time frame: 2 years
Bioimpedance
Time frame: 2 years
Breast cancer related lymphedema symptoms
Time frame: 2 years
Incidence of progression to late stage breast cancer related lymphedema
Time frame: 2 years
Health-related quality of life
Time frame: 2 years
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 9 Sep 2026.
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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.
Lisa Spiguel, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ICG-guided manual lymphatic drainage, Traditional manual lymphatic drainage and Indocyanine green in people with Breast Cancer, run by University of Florida 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 10 inclusion and 14 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 9 Sep 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.
What does this phase mean?
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?
Contact Madeline Campellone ((352) 273-5128, mcampellone@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject compliance (time frame: 2 years). 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 9 Sep 2026.