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

NCT05236387 | Terminated FDA Drug

• 1 other identifier: IRB00154162
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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. This study will also evaluate pain and discomfort after injection and pathological features of clipped nodes and any additional nodes removed.

Conditions

Breast Cancer

Keywords

Lymphoseek; Sentinel Lymph Nodes; Neo Adjuvant Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Percentage of clipped nodes detected with 99m Tc-Tm intraoperatively as determined with a hand held gamma detection device

  The percentage of clipped nodes identified using 99mTc-TM will be calculated, along with an exact binomial 95% confidence interval.

  1 month after the surgery

Secondary Outcomes (3)

• Change in Pain at injection site as assessed by a visual analog scale

  Immediately before injection and at 1 minute after injection

• Number of clipped nodes that were SLNs

  1 month after the surgery

• Concordance of blue/hot nodes for clipped and SLNs as assessed by Lymphoseek with the highest counts on the Gamma counter

  1 month after the surgery

Study Arms (1)

Intent to Treat group

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.

Drug: 99m Tc-TM

Interventions

99m Tc-TM DRUG

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.

Also known as: Lymphoseek

Intent to Treat group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Intent-to-treat population All patients meeting entrance criteria, injected with 99mTc-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.

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).

Sponsors & Collaborators

• Johns Hopkins University: lead
• Cardinal Health: collaborator

Study Sites (1)

Johns Hopkins Bayview Hospital

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

technetium Tc 99m tetramethyl-propyleneamine oxime; technetium-diethylenetriaminepentaacetic acid-mannosyl-dextran

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mehran Habibi, MD

  Johns Hopkins Bayview

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: February 11, 2022
• Study Start: March 1, 2022
• Primary Completion: May 23, 2023
• Study Completion: June 30, 2023
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)