Evaluating the Ability of 99mTc-Tilmanocept to Identify Clipped Nodes in Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy and Sentinel Lymph Node Dissection

Stopped early

Conditions studied: Breast Cancer

In brief

The purpose of the present study is to evaluate the ability of 99mTc-TM to identify the clipped node after neoadjuvant chemotherapy (NAC) and to compare this percentage with historical national data. This study will also evaluate pain and discomfort after injection and pathological features of clipped nodes and any additional nodes removed.

Key facts

Study ID

NCT05236387

Run by

Johns Hopkins University

People needed

14

Starts

2022-03-01

Expected to finish

2023-06-30

Last updated by the study team

2024-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient has provided written informed consent with HIPAA authorization.
• The patient is female or male and ≥18 years of age at the time of consent.
• The patient has been diagnosed with invasive Stage 2-3 breast cancer (T1-3; N1-2).
• The patient has no history of inflammatory breast cancer.
• The patient has no matted node on examination (N3).
• The patient is eligible for neoadjuvant chemotherapy (NAC).
• The patient is a candidate for surgical intervention, with sentinel lymph node assessment being a part of the surgical plan.
• If of childbearing potential, the patient has a negative pregnancy test within 48 hours before administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year.
• The patient has no known allergies or hypersensitivity to 99mTc-TM, BD, or India ink.

You may not qualify if…

• The patient is pregnant or lactating.
• The patient has clinical and/or radiological evidence of metastatic or systemic disease. Oligo metastatic disease is acceptable (one organ and controlled).

Where it is running

• Johns Hopkins Bayview Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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