Status:
TERMINATED
Evaluating the Ability of 99mTc-Tilmanocept to Identify Clipped Nodes in Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy and Sentinel Lymph Node Dissection
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Cardinal Health
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Brief Summary
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. ...
Detailed Description
This is a phase 4 single-center, open-label, single-arm study evaluating the ability of 99mTc-TM to identify clipped nodes in primary breast cancer patients receiving NAC and subsequent Sentinel Lymph...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
March 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT05236387
Start Date
March 1 2022
End Date
June 30 2023
Last Update
February 9 2024
Active Locations (1)
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1
Johns Hopkins Bayview Hospital
Baltimore, Maryland, United States, 21224