NCT04947917

Axillary Lymph Node Tattoo Marking Study

Axillary Lymph Node Tattoo Marking Versus Biopsy Marker and Radioseed Tagging in Patients With Known Primary Breast Cancer

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study investigates if SpotTM ink can help breast surgeons retrieve sampled lymph node as well as or better than the standard clip and radioseed guidance methods. The names of the novel study intervention involved in this study is: * SpotTM ink tattooing The names of the standard of care study interventions involved in this study are: * Core needle biopsy and/or fine needle aspiration * Surgical Removal of the Lymph Nodes via clip and radioseed guidance

Detailed description

This research study is a Feasibility Study, in which investigators are examining SpotTM ink to find out if retrieval rates of the inked lymph node at surgery are as good as or better than the standard of care, which is to clip and then radioseed-label the positive axillary lymph node. This research study involves placement of SpotTM ink on the surface of the lymph node at the time of sampling. As per standard of care, if the lymph node is positive for malignant cells, the surgeon will remove the lymph node at the time of surgical excision. The lymph node tissue will then be evaluated by the pathologist. The U.S. Food and Drug Administration (FDA) has approved SpotTM ink for use in the large intestine to mark colon polyps. The FDA has not approved SpotTM ink for use in axillary lymph nodes. However, SpotTM ink has been used in axillary lymph nodes by other institutions in smaller studies similar to this one with success in retrieving the lymph node after surgery. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Participants will be in this research study until surgical removal of their breast cancer and lymph nodes after their tattoo ink placement.

Conditions

• Breast Cancer
• Lymph Node Metastases

Interventions

Type	Name	Description
PROCEDURE	SpotTM Tattoo Ink	Ink injection

Timeline

• Start date: 2021-12-29
• Primary completion: 2023-04-13
• Completion: 2023-04-13
• First posted: 2021-07-01
• Last updated: 2024-01-23

Locations

1 site across 1 country: United States