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Trial Title:
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
NCT ID:
NCT06327490
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
breast cancer-related lymphedema
ICG-Lymphography Guided Manual Lymphatic Drainage
limb volume changes
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
ICG-guided manual lymphatic drainage
Description:
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.
Arm group label:
ICG-guided manual lymphatic drainage
Intervention type:
Procedure
Intervention name:
Traditional manual lymphatic drainage
Description:
Participants will perform manual lymphatic drainage on their affected arm using
traditional technique once daily for 2 years post-surgery.
Arm group label:
Traditional manual lymphatic drainage
Intervention type:
Drug
Intervention name:
Indocyanine green
Description:
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.
Arm group label:
ICG-guided manual lymphatic drainage
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. 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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).
- 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.
Exclusion Criteria:
- 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 history of or concurrent malignancy of the ipsilateral or
contralateral 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
- 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 history of allergy to ICG or Iodine/Shellfish
- Patients with evidence of liver dysfunction including diagnosis of end stage liver
disease or abnormal liver tests at pre-op workup
- 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, anatomy, procedure: 1)
Identification and preservation of axillary vein, long thoracic nerve, thoracodorsal
nerve; 2) Complete Level I and Level II axillary dissection (with or without Level
III and Rotter's node dissection at the treating surgeon's discretion).
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Florida
Address:
City:
Gainesville
Zip:
32610
Country:
United States
Status:
Recruiting
Contact:
Last name:
Audrianna Macchia
Phone:
352-433-0421
Email:
amacchia@ufl.edu
Investigator:
Last name:
Lisa Spiguel, MD
Email:
Principal Investigator
Start date:
October 2024
Completion date:
June 2028
Lead sponsor:
Agency:
University of Florida
Agency class:
Other
Source:
University of Florida
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06327490