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

Trial Summary

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 data supports the effectiveness of the treatment Lymphoscintigraphy for Breast Cancer?

Lymphoscintigraphy is used to help identify sentinel lymph nodes (the first few lymph nodes where cancer is likely to spread) during breast cancer surgery. Many centers find it valuable for guiding surgery and confirming results, especially for those new to the technique. ^{1 2 3 4 5}

Is lymphoscintigraphy safe for humans?

Lymphoscintigraphy is generally safe for humans, as it involves a simple injection of small amounts of radiotracers that rarely cause allergic reactions and are safe for patients with respiratory issues. ^{6 7 8 9 10}

How does lymphoscintigraphy differ from other treatments for breast cancer?

Lymphoscintigraphy is unique because it helps map the lymphatic drainage and locate sentinel lymph nodes before surgery, which can guide the surgical approach and potentially reduce the extent of surgery needed. Unlike other treatments, it does not directly treat cancer but aids in surgical planning and may help tailor radiation therapy to individual patients. ^{3 8 10 11 12}

What is the purpose of this trial?

This Feasibility study is trying to determine: * If Lymphoscintigraphy (imaging of the lymphatic drainage patterns) is effective in demonstrating the drainage to the sentinel lymph nodes in patients with inflammatory breast cancer. * The likelihood of identifying the sentinel lymph nodes in the operating room, using both blue dye and the radioactive substance used for lymphoscintigraphy. * The incidence of lymphedema (arm swelling which occurs after lymph node surgery) in women with inflammatory breast cancer * Outcomes for women with inflammatory breast cancer, whether or not the sentinel lymph nodes can be identified.

Research Team

Faina Nahklis, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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]

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]

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 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, 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]

References

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

Correlation of lymphoscintigraphy with the number of sentinel lymph nodes identified intraoperatively in patients with breast cancer. [2016]

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

Routine preoperative lymphoscintigraphy is not necessary prior to sentinel node biopsy for breast cancer. [2019]

3. China pubmed.ncbi.nlm.nih.gov

[Lymphoscintigraphy in sentinel lymph node biopsy of breast cancer]. [2006]

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

Technical aspects of performing lymphoscintigraphy: optimization of methods used to obtain images. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Roles of preoperative lymphoscintigraphy for sentinel lymph node biopsy in breast cancer patients. [2016]

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

Nonvisualization of a sentinel lymph node on lymphoscintigraphy requiring reinjection of sulfur colloid in a patient with breast cancer. [2016]

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

Lymphoscintigraphy for Imaging of the Lymphatic Flow Disorders. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Sentinel lymph node biopsy in breast cancer--is lymphoscintigraphy really necessary? [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

Risk factors for nonvisualization of the sentinel lymph node on lymphoscintigraphy in breast cancer patients. [2021]

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

Lymphoscintigraphy does not enhance sentinel node identification or alter management of patients with early breast cancer. [2016]

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

Mammary lymphoscintigraphy in breast cancer. [2016]

12. France pubmed.ncbi.nlm.nih.gov

[Cancer of the breast: the return of lymphoscintigraphy?]. [2016]