ICG-Guided vs. Traditional Lymphatic Drainage for Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Lisa Spiguel, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Florida

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

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment ICG-guided manual lymphatic drainage for breast cancer?

Research shows that manual lymphatic drainage (MLD) can improve the quality of life in patients with chronic venous disease and is used in breast cancer-related lymphedema. Indocyanine green (ICG) lymphography helps guide personalized MLD, which has been integrated into clinical practice to manage lymphedema effectively. ^{1 2 3 4 5}

What makes ICG-guided manual lymphatic drainage unique compared to traditional methods for breast cancer treatment?

ICG-guided manual lymphatic drainage uses indocyanine green (ICG) to provide real-time fluorescent imaging, which helps in accurately mapping lymphatic pathways and potentially improving the effectiveness of lymphatic drainage compared to traditional methods that do not use this imaging technique. ^{5 6 7 8 9}

Research Team

Lisa Spiguel, MD

Principal Investigator

University of Florida

Eligibility Criteria

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 18 years old or older.

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

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.

Trial Timeline

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

Treatment Details

Interventions

• ICG-guided manual lymphatic drainage (Procedure)
• Traditional manual lymphatic drainage (Procedure)

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.

Participant Groups

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+

Dr. Stephen J. Motew

University of Florida

Chief Executive Officer since 2024

MD cum laude from the University of Illinois at Chicago School of Medicine, Master's in Healthcare Administration from the University of North Carolina at Chapel Hill

Dr. Timothy E. Morey

University of Florida

Chief Medical Officer since 2023

MD and Bachelor's from the University of Florida

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of Manual Lymphatic Drainage on Breast Cancer-Related Postmastectomy Lymphedema: A Meta-analysis of Randomized Controlled Trials. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Manual Lymphatic Drainage for Breast Cancer-related Lymphedema: A Systematic Review and Meta-analysis of Randomized Controlled Trials. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Personalizing Conservative Lymphedema Management Using Indocyanine Green-Guided Manual Lymphatic Drainage. [2021]

4. Poland pubmed.ncbi.nlm.nih.gov

Manual lymphatic drainage improves the quality of life in patients with chronic venous disease: a randomized controlled trial. [2021]

5. United States 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Fluorescent lymphography for thoracic duct identification: Initial experience of a simplified and feasible ICG administration. [2022]

7. Switzerland 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. [2022]

8. United States 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. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Breast cancer sentinel lymph node mapping using near-infrared guided indocyanine green in comparison with blue dye. [2022]