Lymphoscintigraphy for Breast Cancer

Overseen By Faina Nahklis, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Stage IV breast cancer, others

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether lymphoscintigraphy, a special imaging technique, can effectively show lymph fluid drainage in women with inflammatory breast cancer. The goal is to determine if this technique can help identify the sentinel lymph nodes (the first nodes cancer is likely to spread to) during surgery. The trial also examines the risk of developing arm swelling (lymphedema) after surgery. Women diagnosed with inflammatory breast cancer who have not yet started pre-operative therapy may be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to pioneering research that could improve surgical outcomes for future patients.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that lymphoscintigraphy is safe for sentinel lymph node identification in breast cancer patients?

Research has shown that lymphoscintigraphy, a method used to map lymph drainage, is generally safe for breast cancer patients. This imaging technique identifies which lymph nodes might have cancer by injecting a small amount of radioactive material to track lymph fluid movement.

In a large study with breast cancer patients, only a few returned to the hospital after the procedure, indicating that serious side effects are rare. Most issues were minor, such as temporary discomfort at the injection site.

Overall, lymphoscintigraphy is well-tolerated, and serious side effects are uncommon. This procedure has a long history in breast cancer treatment, demonstrating a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of Lymphoscintigraphy for breast cancer because it offers a unique way to map the drainage paths of the lymphatic system from the breast, which is crucial for identifying sentinel nodes. Unlike traditional methods that might solely rely on surgical exploration or imaging at a single point in time, Lymphoscintigraphy involves a series of imaging studies both before chemotherapy and just before surgery. This dual-timepoint approach allows for more accurate identification of sentinel nodes, which are the first lymph nodes to which cancer cells are likely to spread. By using this detailed mapping, surgeons can target and remove only the necessary nodes initially, potentially reducing the extent of surgery and minimizing risks like lymphedema.

What evidence suggests that lymphoscintigraphy is effective for identifying sentinel lymph nodes in inflammatory breast cancer?

Studies have shown that lymphoscintigraphy can effectively map lymph fluid drainage in breast cancer patients. In this trial, participants will undergo lymphoscintigraphy to help doctors locate the sentinel lymph nodes, the first places cancer often spreads. Identifying these nodes is crucial for planning treatment. Research indicates that lymphoscintigraphy helps surgeons focus on the right areas during surgery. When combined with a blue dye, this method improves the chances of accurately finding the sentinel lymph nodes in the operating room. By targeting these specific nodes, the procedure may reduce the need to remove extra lymph nodes, lowering the risk of arm swelling, known as lymphedema. ^{2 4 6 7 8}

Who Is on the Research Team?

Faina Nahklis, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for women over 18 with Stage III inflammatory breast cancer (IBC), which includes rapid onset symptoms, redness and swelling of the breast. They must have a performance status that allows daily activity and be able to consent to study procedures. Those who've started pre-operative therapy or have metastatic cancer, positive contralateral axillary nodes, or contralateral invasive breast cancer are excluded.

Exclusion Criteria

I do not have cancer in the lymph nodes under my opposite arm as confirmed by imaging and biopsy.

I do not have stage IV breast cancer and no signs of cancer spread were found in my initial tests.

I have not started any treatment before signing up for this trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Evaluation

Participants undergo lymphoscintigraphy to determine lymphatic drainage patterns

1 week

2 visits (in-person)

Surgery

Sentinel lymph node biopsy and standard axillary lymph node removal

1 day

1 visit (in-person)

Follow-up

Participants are monitored for lymphedema and recurrence post-surgery

2 years

Every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Lymphoscintigraphy

Trial Overview The study tests if Lymphoscintigraphy can effectively show lymph drainage patterns in IBC patients and identify sentinel lymph nodes during surgery using blue dye and radioactive substances. It also examines the occurrence of lymphedema post-surgery and overall outcomes for IBC patients.

How Is the Trial Designed?

Group I: Sentinal Node Identification Experimental Treatment 1 Intervention

Within standard of care treatment for inflammatory breast cancer, participants will undergo a series of Lymphoscintigraphies: an imaging procedure to determine where their lymphatic system drains from their breast. * Prior to neoadjuvant chemotherapy * Day before surgery These two imaging studies will be compared and the information used during participant's surgery to perform the sentinel node biopsy procedure. During surgery participants will have a blue dye injected to affected breast to map drainage and identify sentinal nodes. The sentinal nodes will be removed first, followed by standard of care procedure to remove all axillary lymph nodes. After surgery, a small amount of tissue from the tumor removed during surgery will be evaluated. Participants will complete a Lymphedema Questionnaire after each Lymphoscintigraphy then every 6 months for 2 years post surgery.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Published Research Related to This Trial

Lymphoscintigraphy effectively mapped lymphatic drainage patterns in 34 patients with suspected breast cancer, successfully identifying sentinel lymph nodes in nearly all cases, which is crucial for surgical planning.

The study revealed unexpected drainage patterns, including cross-midline drainage in 32% of patients, highlighting the importance of individualized mapping for accurate sentinel node localization in breast cancer surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mammary lymphoscintigraphy in breast cancer. Uren, RF., Howman-Giles, RB., Thompson, JF., et al.[2016]

Lymphoscintigraphy was successful in identifying sentinel nodes in 84% of the 62 breast cancer patients studied, but it did not improve the detection rate of axillary sentinel nodes during surgery.

Even when lymphoscintigraphy was unsuccessful in 10 patients, 8 of them still had their axillary sentinel nodes identified during the procedure, suggesting that lymphoscintigraphy may not be essential for axillary node detection but could be useful for locating extra-axillary nodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel lymph node biopsy in breast cancer--is lymphoscintigraphy really necessary? Upponi, SS., McIntosh, SA., Wishart, GC., et al.[2019]

Lymphoscintigraphy is a valuable imaging technique for sentinel node detection in breast cancer, helping surgeons visualize and confirm sentinel nodes during surgery, despite ongoing debates about its optimal use.

The authors provide practical recommendations to enhance the effectiveness of lymphoscintigraphy, aiming to improve sentinel node visualization and detection accuracy for both experienced centers and those new to the technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical aspects of performing lymphoscintigraphy: optimization of methods used to obtain images. Krynyckyi, BR., Miner, M., Ragonese, JM., et al.[2022]

Lymphoscintigraphy is crucial for identifying sentinel lymph nodes (SLNs) in breast cancer patients, especially those who have undergone prior surgeries, as demonstrated by a case where initial injections failed to show lymphatic drainage.

In this case, additional injections of a radioactive tracer led to successful visualization and identification of the SLN, highlighting the importance of tailored injection techniques in improving identification rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonvisualization of a sentinel lymph node on lymphoscintigraphy requiring reinjection of sulfur colloid in a patient with breast cancer. Teal, CB., Brem, RF., Rapelyea, JA., et al.[2016]

Lymphoscintigraphy is a safe and effective diagnostic imaging technique for lymphatic flow disorders, suitable for patients of all ages, including neonates and those in critical conditions.

The procedure involves a simple subcutaneous injection of radiotracers, which are less likely to cause allergic reactions compared to iodine contrast media and do not pose a risk of pulmonary embolism, making it safer for patients with respiratory issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lymphoscintigraphy for Imaging of the Lymphatic Flow Disorders. Yoshida, RY., Kariya, S., Ha-Kawa, S., et al.[2022]

In a study of 1886 sentinel lymph node (SLN) procedures, the nonvisualization rate on lymphoscintigraphy was 25.1%, which significantly decreased to 9.4% after a reinjection of the radiotracer, indicating that reinjection can improve visualization rates.

Key risk factors for SLN nonvisualization included being aged 70 years or older, having a body mass index (BMI) of 30 kg/m² or higher, and having nonpalpable tumors, suggesting that these patient characteristics should be considered when planning SLN procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for nonvisualization of the sentinel lymph node on lymphoscintigraphy in breast cancer patients. Chahid, Y., Qiu, X., van de Garde, EMW., et al.[2021]

Lymphoscintigraphy (LS) was performed on 136 breast cancer patients before sentinel lymph node dissection (SLND), and while it failed to identify sentinel nodes in 6.6% of cases, this did not impact the overall success of identifying sentinel nodes during surgery, as all patients had their sentinel nodes identified.

The study found a significant correlation between higher body mass index (BMI) and failed LS, but LS findings did not influence postoperative management or treatment decisions for patients, indicating that LS may not be necessary for enhancing surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lymphoscintigraphy does not enhance sentinel node identification or alter management of patients with early breast cancer. Shoher, A., Diwan, A., Teh, BS., et al.[2016]

Lymphoscintigraphy successfully identified lymphatic drainage in 93% of 95 breast cancer patients, demonstrating its feasibility for guiding sentinel lymph node biopsy.

The method resulted in a high identification rate of sentinel lymph nodes (95.8%) during surgery, indicating that combining lymphoscintigraphy with a gamma detector probe is both effective and promising for this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Lymphoscintigraphy in sentinel lymph node biopsy of breast cancer]. Zhang, J., Shen, K., Nirmal, L., et al.[2006]

Lymphoscintigraphy, once promising for predicting breast cancer metastasis, is being reconsidered for its potential to tailor regional irradiation strategies based on individual lymphatic drainage, despite its previous abandonment due to limitations in predicting metastatic status.

The technique may enhance the precision of identifying sentinel nodes and adapting irradiation fields, potentially reducing surgery-related morbidity in 70% of patients, while new imaging technologies could improve the clinical impact by accurately locating nodes in critical areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cancer of the breast: the return of lymphoscintigraphy?]. Pourquier, D., Lemanski, C., Faurous, P., et al.[2016]

Lymphoscintigraphy accurately predicted the number of radioactive sentinel lymph nodes (SLNs) identified during surgery in only 47% of breast cancer patients studied, indicating limited reliability in this context.

In most cases where lymphoscintigraphy was not concordant, the actual number of SLNs identified during surgery was higher than predicted, suggesting that while lymphoscintigraphy can indicate the presence of at least one SLN, it often underestimates the total number identified.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation of lymphoscintigraphy with the number of sentinel lymph nodes identified intraoperatively in patients with breast cancer. Teal, CB., Slocum, JP., Akin, EA., et al.[2016]

In a study of 565 breast cancer patients, preoperative lymphoscintigraphy did not improve the identification rate of sentinel lymph nodes during biopsy, achieving a high identification rate of 99.3% regardless of lymphoscintigraphy use.

The false-negative rates for sentinel lymph node biopsy were similar between groups with (4.2%) and without (4.8%) lymphoscintigraphy, indicating that this imaging technique is not necessary for effective sentinel lymph node biopsy in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Roles of preoperative lymphoscintigraphy for sentinel lymph node biopsy in breast cancer patients. Sun, X., Liu, JJ., Wang, YS., et al.[2016]

In a study of 50 patients with invasive breast cancer, sentinel node identification was successful in 90% of cases, with a 0% false negative rate for those with axillary nodal metastases, indicating high accuracy in detecting cancer spread.

Preoperative lymphoscintigraphy did not significantly improve sentinel lymph node localization or reduce false negative rates compared to standard intraoperative lymphatic mapping, suggesting that its routine use may not be necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Routine preoperative lymphoscintigraphy is not necessary prior to sentinel node biopsy for breast cancer. Burak, WE., Walker, MJ., Yee, LD., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10297396/

Sentinel Lymph Node Detection in Breast Cancer (1) Background: Sentinel lymph node biopsy is important in the search for metastases, especially in patients with malignant breast disease.

2. ascopubs.org ascopubs.org/doi/10.1200/JCO-25-00099

Sentinel Lymph Node Biopsy in Early-Stage Breast Cancer ... lymph node dissection did not improve cancer outcomes ... trials have demonstrated that dissection of the IM node did not improve survival.

3. dana-farber.org dana-farber.org/clinical-trials/20-151

Refining Local-Regional Therapy for Inflammatory Breast ... This Feasibility study is trying to determine: - If Lymphoscintigraphy (imaging of the lymphatic drainage patterns) is effective in demonstrating the drainage

4. sciencedirect.com sciencedirect.com/science/article/pii/S2773160X25000169

Outpatient revisits associated with three sentinel lymph ... This retrospective observational study included adult female patients with a breast cancer diagnosis who underwent SLN mapping and had an ...

5. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2809872

Sentinel Lymph Node Biopsy vs No Axillary Surgery in ... This randomized clinical trial assesses whether the omission of sentinel node biopsy is noninferior to sentinel lymph node biopsy in female ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12208209/

The Impact of Lymphoscintigraphy Visualization on ... Lymphoscintigraphy visualization status was not significantly associated with OS and RFS in patients with early breast cancer undergoing SLNB.

7. emedicine.medscape.com emedicine.medscape.com/article/1890647-overview

Breast Cancer Lymphoscintigraphy (Sentinel Lymph Node ... Lymphoscintigraphy (sentinel lymph node mapping) is an imaging technique that is used to identify the lymph drainage basin, determine the number of sentinel ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9187279/

Value of Quantitative SPECT/CT Lymphoscintigraphy in ... Our data preliminarily demonstrated that 99 m Tc-SC SPECT/CT has the potential to indicate AS and identify the nature of lymph nodes in breast ...