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Lymphoscintigraphy for Breast Cancer

N/A

Recruiting

Led By Faina Nahklis, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Participants who initiated pre-operative/neoadjuvant therapy prior to registration are ineligible.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 2 years from surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if Lymphoscintigraphy can help find the sentinel lymph nodes in patients with inflammatory breast cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from imaging procedures, allergic reactions to dyes or radioactive materials used, risks associated with biopsy such as bleeding or infection, and possible development of lymphedema after node surgery.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 2 years from surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 2 years from surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 2 years from surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Sentinel Lymph Node (SLN) identification rate

Secondary study objectives

Disease-free survival (DFS)

Distant recurrence-free survival rate (DRFS)

Local-regional recurrence free survival rate (LRRFS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Sentinal Node IdentificationExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lymphoscintigraphy

2012

Completed Phase 2

~530

0 / 1Eligibility criteria met