Clinical trial · Observational
Evaluating the Ability of 99mTc-Tilmanocept to Identify Clipped Nodes in Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy and Sentinel Lymph Node Dissection
A Single-Center, Open-Label Study Evaluating the Ability of 99mTc-Tilmanocept to Identify Clipped Nodes in Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy and Sentinel Lymph Node Dissection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI left institution
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 99m Tc-TM | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Intent to Treat group
- description
- All patients meeting entrance criteria, injected with 99m Tc-TM, and having one or more lymph nodes removed for which the pathologist confirms the type (lymph node versus non-lymph node) and contents (e.g., tumor cells) of the excised tissues will comprise the intent-to-treat population (ITT). This definition also carries over to the lymph nodes; i.e., nodes used for the ITT analysis must come from patients included in the ITT population. The ITT population will serve as the analysis population for all efficacy endpoints, unless indicated otherwise in the description of analyses.
- interventionNames
- Drug: 99m Tc-TM
Primary outcomes (1)
- measure
- Percentage of clipped nodes detected with 99m Tc-Tm intraoperatively as determined with a hand held gamma detection device
- timeFrame
- 1 month after the surgery
- description
- The percentage of clipped nodes identified using 99mTc-TM will be calculated, along with an exact binomial 95% confidence interval.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. The patient has provided written informed consent with HIPAA authorization. 2. The patient is female or male and ≥18 years of age at the time of consent. 3. The patient has been diagnosed with invasive Stage 2-3 breast cancer (T1-3; N1-2). 4. The patient has no history of inflammatory breast cancer. 5. The patient has no matted node on examination (N3). 6. The patient is eligible for neoadjuvant chemotherapy (NAC). 7. The patient is a candidate for surgical intervention, with sentinel lymph node assessment being a part of the surgical plan. 8. 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. 9. The patient has no known allergies or hypersensitivity to 99mTc-TM, BD, or India ink. Exclusion Criteria: 1. The patient is pregnant or lactating. 2. The patient has clinical and/or radiological evidence of metastatic or systemic disease. Oligo metastatic disease is acceptable (one organ and controlled).
References
Publications (0)
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