ICG-Guided vs. Traditional Lymphatic Drainage for Breast Cancer

Overseen By Judy Walsh

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Florida

Disqualifiers: Ipsilateral breast cancer, Bilateral breast cancer, Cardiac disease, Liver dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to manage lymphedema, a common side effect of breast cancer treatment involving swelling from fluid build-up. It compares two manual lymphatic drainage methods (a type of massage therapy) to determine if guiding the therapy with ICG-lymphography (a special imaging technique) proves more effective than the traditional approach. Women recently diagnosed with breast cancer who have undergone or will undergo axillary lymph node dissection (removal of lymph nodes in the armpit area) may qualify to participate. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in managing lymphedema.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this method is safe for breast cancer patients?

Studies have shown that manual lymphatic drainage (MLD) can help prevent lymphedema, a swelling caused by fluid buildup, after breast cancer surgery. A new method, ICG-guided MLD, uses a special dye to map a patient's lymphatic system, allowing for more precise massage.

Research has shown that ICG, the dye used in this process, is generally safe. No major safety concerns have been reported when using ICG to guide MLD, suggesting that ICG-guided MLD is likely well-tolerated. However, more studies are needed to fully understand its safety.

Traditional MLD is already widely used and considered safe for managing lymphedema, with most people experiencing few side effects.

In summary, both ICG-guided and traditional MLD appear safe based on current information, but ICG-guided MLD is newer and still under study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new method, ICG-guided manual lymphatic drainage, for managing breast cancer-related lymphatic issues. Unlike traditional manual lymphatic drainage, this approach uses indocyanine green (ICG) dye to provide real-time visualization of lymphatic pathways. This could potentially improve the precision and effectiveness of lymphatic drainage, offering a more targeted approach to alleviate symptoms. Researchers hope to find out if this method can lead to better outcomes for patients compared to the traditional technique.

What evidence suggests that ICG-guided manual lymphatic drainage is effective for breast cancer related lymphedema?

This trial will compare ICG-guided manual lymphatic drainage (MLD) with traditional manual lymphatic drainage for treating lymphedema after breast cancer surgery. Research has shown that ICG-guided MLD might enhance treatment effectiveness. This technique uses a special dye to map the lymphatic system, guiding the massage therapy more precisely. Studies have found that traditional MLD can help prevent lymphedema, and using ICG might increase its effectiveness. Early results suggest that ICG can better target the therapy, possibly improving patient outcomes. While more research is needed, these initial findings are encouraging. ^{1 2 3 5 6}

Who Is on the Research Team?

Lisa Spiguel, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for breast cancer patients undergoing axillary node dissection. It's designed to see if a new type of manual lymphatic drainage (MLD) guided by indocyanine-green (ICG) imaging can help prevent lymphedema, which is swelling due to fluid build-up after breast cancer treatment.

Inclusion Criteria

I am fully active or can carry out light work.

Subjects of childbearing potential 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

I will have a physical therapy evaluation before my lymph node surgery.

Exclusion Criteria

I have had surgery on the same side's armpit area before.

Patients who are confirmed to be pregnant or breastfeeding

I am scheduled for or have had surgery on the opposite underarm area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive manual lymphatic drainage (MLD) guided by either ICG-lymphography or traditional methods

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ICG-guided manual lymphatic drainage
• Traditional manual lymphatic drainage

Trial Overview The study compares two MLD techniques in preventing lymphedema: the new ICG-guided method that uses special imaging to tailor the massage to each patient's unique lymphatic system, and the traditional approach without such guidance.

How Is the Trial Designed?

Group I: ICG-guided manual lymphatic drainage Experimental Treatment 2 Interventions

Group II: Traditional manual lymphatic drainage Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

Manual lymphatic drainage (MLD) significantly reduced foot volumetry (FV) and improved quality of life (QoL) in chronic venous disease (CVD) patients, as shown in a study with 70 participants over a 2-week preoperative period.

Patients who underwent MLD before surgery experienced better surgical outcomes, including reduced disease progression and improved clinical staging, compared to those who did not receive MLD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manual lymphatic drainage improves the quality of life in patients with chronic venous disease: a randomized controlled trial. Molski, P., Kruczyński, J., Molski, A., et al.[2021]

In a study involving 457 patients, manual lymphatic drainage (MLD) did not show a significant overall reduction in upper extremity edema compared to no treatment, indicating its efficacy remains uncertain.

However, when patients received 20 or more MLD sessions or underwent treatment for more than 2 weeks, there was a significant reduction in limb volume, suggesting that the effectiveness of MLD may depend on the treatment duration and frequency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Manual Lymphatic Drainage on Breast Cancer-Related Postmastectomy Lymphedema: A Meta-analysis of Randomized Controlled Trials. Qiao, J., Yang, LN., Kong, YH., et al.[2023]

The study involving 150 patients showed that the novel dual tracer method using indocyanine green and radioisotope (ICG-RI) identified a similar number of sentinel lymph nodes (SLNs) as the traditional blue dye and radioisotope method (BD-RI), with no cases of failed mapping in either technique.

ICG-RI was found to be safer, with no adverse reactions reported, while the BD-RI method had cases of skin tattooing and anaphylaxis, although ICG-RI came with a higher cost of AU$197.38 per case.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Dual Tracer Indocyanine Green and Radioisotope Versus Gold Standard Sentinel Lymph Node Biopsy in Breast Cancer: The GREENORBLUE Trial. Nguyen, CL., Zhou, M., Easwaralingam, N., et al.[2023]

Manual lymphatic drainage (MLD) significantly reduces pain intensity in breast cancer-related lymphedema (BCRL) patients, based on a meta-analysis of 11 randomized controlled trials involving 1564 participants.

While MLD shows promise in reducing the incidence of lymphedema, it does not significantly improve volumetric changes of lymphedema or quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manual Lymphatic Drainage for Breast Cancer-related Lymphedema: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Lin, Y., Yang, Y., Zhang, X., et al.[2022]

In a clinical trial involving 68 breast cancer patients, near-infrared fluorescence imaging using indocyanine green (ICG) significantly improved the detection rate of sentinel lymph nodes (SLNs) compared to traditional blue dye imaging, with detection rates of 97.2% versus 81.3%.

The ICG fluorescence method also allowed for the identification of more SLNs on average (3.6 SLNs) compared to blue dye (2.1 SLNs), indicating its potential to enhance surgical outcomes in sentinel lymph node biopsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer sentinel lymph node mapping using near-infrared guided indocyanine green in comparison with blue dye. Guo, W., Zhang, L., Ji, J., et al.[2022]

In a study of 240 women with early breast cancer, indocyanine green (ICG) achieved a 100% detection rate for sentinel lymph nodes, outperforming blue dye, which had a 97.5% detection rate.

ICG is a promising alternative to blue dye for sentinel lymph node biopsy, offering similar efficacy without the need for radioactive isotopes, making it easier to learn and more cost-effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Prospective Non-Inferiority Trial of Sentinel Lymph Node Biopsy in Early Breast Cancer: Blue Dye Compared with Indocyanine Green Fluorescence Tracer. Coibion, M., Olivier, F., Courtois, A., et al.[2022]

Indocyanine green (ICG) combined with methylene blue (MB) dye is as effective as the traditional technetium-99 (Tc-99) plus MB dye for sentinel lymph node biopsy (SLNB) in early breast cancer, with similar identification rates and positivity rates.

The study involved 207 patients and found that ICG + MB identified slightly fewer sentinel lymph nodes (2.73) compared to Tc-99 + MB (3.17), but both methods showed comparable effectiveness, making ICG a viable alternative in settings with limited access to Tc-99.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic Performance of Indocyanine Green Plus Methylene Blue Versus Radioisotope Plus Methylene Blue Dye Method for Sentinel Lymph Node Biopsy in Node-Negative Early Breast Cancer. Agrawal, SK., Hashlamoun, I., Karki, B., et al.[2021]

A simplified method for administering indocyanine green (ICG) lymphography was successfully tested in 18 patients, allowing visualization of the thoracic duct without the need for ultrasound guidance.

This technique enables unqualified personnel to perform the procedure safely and efficiently, achieving results comparable to traditional methods while facilitating easier identification and dissection of the thoracic duct during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluorescent lymphography for thoracic duct identification: Initial experience of a simplified and feasible ICG administration. Barbato, G., Cammelli, F., Braccini, G., et al.[2022]

A study of 339 patients with cancer-related lymphedema revealed that ICG lymphography effectively identifies compensatory drainage patterns, which can inform personalized treatment plans.

In upper limb lymphedema, the majority of patients (74.9%) showed drainage to the ipsilateral axilla, while in lower limb cases, the most common drainage site was the ipsilateral inguinal region (52.3%), highlighting the importance of targeted manual lymphatic drainage techniques based on these patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalizing Conservative Lymphedema Management Using Indocyanine Green-Guided Manual Lymphatic Drainage. Koelmeyer, LA., Thompson, BM., Mackie, H., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8007464/

Manual lymphatic drainage guided by real-time ... Moreover, MLD has shown promising results in terms of preventing lymphedema after breast cancer surgery [3]. However, special care should be ...

2. ufhealth.org ufhealth.org/clinical-trials/icg-guided-manual-lymphatic-drainage-in-breast-cancer

ICG-Guided Manual Lymphatic Drainage in Breast Cancer This study investigates a new method of MLD, which is guided by the individual patients' lymphatic anatomy through use of ICG-lymphography. Details. Full study ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12196954/

ICG Lymphography Confirms the Presence of an ... This case reinforces the critical role of long-term lymphedema therapy—including MLD, compression therapy, and self-care strategies—in ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-01955

Indocyanine Green-Guided Manual Lymphatic Drainage ... This clinical trial compares indocyanine green (ICG)-guided manual lymphatic drainage (MLD) to traditional MLD for the prevention of late-stage breast cancer ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02609724

Effectiveness of Fluoroscopy-guided MLD for Treatment ... Effects of manual lymphatic drainage on breast cancer-related lymphedema: a systematic review and meta-analysis of randomized controlled trials. World J ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06327490/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 Study Evaluating the Feasibility and Compliance of ... A Study Evaluating the Feasibility and Compliance of Manual Lymphatic Drainage Comparing Indocyanine-Green (ICG) Guided vs. Traditional Guided ...