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Trial Title:
3D Ultrasound for the Imaging of Lymph Nodes in Patients With Breast Cancer
NCT ID:
NCT05704283
Condition:
Breast Carcinoma
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Ultrasound Imaging
Description:
Undergo 3D-US
Arm group label:
Diagnostic (3D-US)
Other name:
2-Dimensional Grayscale Ultrasound Imaging
Other name:
2-Dimensional Ultrasound Imaging
Other name:
2D-US
Other name:
Ultrasonography
Other name:
Ultrasound
Other name:
Ultrasound Test
Other name:
Ultrasound, Medical
Other name:
US
Summary:
This early phase I studies how well a new 3D ultrasound (3D-US) imaging technology works
in evaluating lymph nodes in patients with breast cancer. Ultrasound uses high-frequency
sound waves to generate images of the body.
Detailed description:
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 lymph nodes in patients.
III. Compare the performance of the new 3D-US method with conventional two-dimensional
(2D)-US for localizing the clipped lymph nodes.
OUTLINE:
Patients undergo 3D-US on study. Patients who have a lymph node clip placed and
undergoing neoadjuvant chemotherapy undergo imaging of the clipped node before surgery.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with lymph node biopsy or lymph node clip placement as per routine clinical
care.
- Age of 18 or older.
Exclusion Criteria:
- Vulnerable subjects such as prisoners and adults lacking capacity to consent.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Shigao D. Chen, Ph.D.
Email:
Principal Investigator
Start date:
February 14, 2023
Completion date:
April 1, 2025
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Collaborator:
Agency:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Agency class:
NIH
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05704283
https://www.mayo.edu/research/clinical-trials
