Evaluating the Ability of 99mTc-Tilmanocept to Identify Clipped Nodes in Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy and Sentinel Lymph Node Dissection
NCT05236387 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 14
Last updated 2024-02-09
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. This study will also evaluate pain and discomfort after injection and pathological features of clipped nodes and any additional nodes removed.
Conditions
Interventions
- DRUG
-
99m Tc-TM
Each patient will receive a single injection (0.1 ml) of 99mTc-TM (50 mcg) at the upper outer skin of the breast using an intradermal technique confirmed by the presence of a skin wheal.
Sponsors & Collaborators
-
Cardinal Health
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Mehran Habibi, MD · Johns Hopkins Bayview
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-01
- Primary Completion
- 2023-05-23
- Completion
- 2023-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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