Refining Local-Regional Therapy for IBC

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT04636710
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lymphoscintigraphy — PROCEDURE
    An imaging procedure using an injected radioactive substance or dye to identify lymph drainage A doctor reviews the images to identify the sentinel lymph nodes based on where the dye goes to first.

Study Details

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.

Key Dates

Start date
Jun 2, 2021
Status verified
Dec 2025
Primary completion
Dec 1, 2027
Completion
Dec 1, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Sentinal Node Identification
    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.

Primary Outcome Measure

Sentinel Lymph Node (SLN) identification rate [ Time Frame: Up to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02115
Faina Nakhlis, MD
[email protected]
617-983-7777
Faina Nakhlis, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Dana Farber Cancer Institute· Boston, MA

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