Recruiting • Phase O • Stage 0, I, II, III, IV • Post-Menopausal • Interventional
The following is imported from ClinicalTrials.gov:
3D Ultrasound for the Imaging of Axillary Lymph Nodes in Patients With Breast Cancer
This early phase I studies how well a new 3D ultrasound (3D-US) imaging technology works in evaluating axillary lymph nodes in patients with breast cancer. Ultrasound uses high-frequency sound waves to generate images of the body.
PRIMARY OBJECTIVES:
I. Conducting a pilot study to optimize the in vivo performance of the newly developed three-dimensional (3D)-ultrasound (US) technology.
II. Evaluate the performance of the new 3D-US technique in differentiating benign from malignant axillary lymph nodes (ALNs).
III. Compare the performance of the new 3D-US method with conventional two-dimensional (2D)-US for localizing the clipped ALNs.
OUTLINE:
Patients undergo 3D-US on study. Patients who have an ALN clip placed and undergoing neoadjuvant chemotherapy undergo imaging of the clipped node before surgery.
Breast Cancer
Study Design
Study type:
Interventional
Estimated enrollment:
60 participant
Actual study start date:
February 14, 2023
Eligibility Criteria
Ages eligible for study:
18 - 999
Sexes eligible for study:
female
Arms and Intervention
Ultrasound Imaging
Inclusion criteria
female patients with breast cancer and scheduled to have axillary lymph node biopsy as per routine clinical care.
age of 18 or older.
Exclusion criteria
vulnerable subjects such as prisoners and adults lacking capacity to consent.