Breast Cancer Stage I Clinical Trial
Official title:
Medical Imaging and Thermal Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)
NCT number | NCT05219695 |
Other study ID # | AAAS9859 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 19, 2022 |
Est. completion date | May 2025 |
The objective of this study is to demonstrate the initial clinical feasibility of using Harmonic Motion Imaging (HMI) for Focused Ultrasound Surgery (FUS) guidance and monitoring in patients with benign and stage 1 non-metastatic breast cancers. The investigators hypothesize that changes in HMI parameters will inform progression of FUS ablation.
Status | Recruiting |
Enrollment | 36 |
Est. completion date | May 2025 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Women age =18 - Patients with fibroadenoma (benign tumor) or early-stage, non-metastatic breast cancer (stage I without the involvement of axillary lymph nodes) - Scheduled to receive surgical resection of the tumor by the clinical care team (ideal target lesion upper boundary should be deeper than 1 cm below the skin, and the ideal size of the lesion should be 2-5 cm in diameter) Exclusion Criteria: - Pregnant or lactating women - Patients with breast implants - Patients with a history of laser or radiation therapy to the targeted breast - Patients who have received or are scheduled to receive thermal ablation or treatment of the tumor (other than surgery) as part of clinical care |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Irving Medical Center/NYP | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University |
United States,
Han Y, Wang S, Hibshoosh H, Taback B, Konofagou E. Tumor characterization and treatment monitoring of postsurgical human breast specimens using harmonic motion imaging (HMI). Breast Cancer Res. 2016 May 9;18(1):46. doi: 10.1186/s13058-016-0707-3. — View Citation
Han Y, Wang S, Payen T, Konofagou E. Fast lesion mapping during HIFU treatment using harmonic motion imaging guided focused ultrasound (HMIgFUS) in vitro and in vivo. Phys Med Biol. 2017 Apr 21;62(8):3111-3123. doi: 10.1088/1361-6560/aa6024. Epub 2017 Mar 21. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with ablation | To identify markers of ablation progression using HMIgFUS images, thereby predicting whether ablation occurred or not. The investigators will also use differences in HMI imaging performed before and after ablation to assess the presence of ablation. The results from both of these methods will be validated with pathological findings, to determine whether ablation was achieved. | From the date of ablation and imaging to the date of pathological results (approximately 1 week) | |
Primary | R2 value of ablated lesion depth | The depth of the lesion (in mm away from the surface of the skin) as shown on HMIgFUS images will be compared and validated with pathological findings. | From the date of ablation and imaging to the date of pathological results (approximately 1 week) | |
Primary | R2 value of ablated lesion width | The width of the lesion (in mm laterally across the lesion) as shown on HMIgFUS images will be compared and validated with pathological findings. | From the date of ablation and imaging to the date of pathological results (approximately 1 week) | |
Primary | R2 value of ablated lesion area | The area of the lesion (in mm^2) as shown on HMIgFUS images will be compared and validated with pathological findings. | From the date of ablation and imaging to the date of pathological results (approximately 1 week) |
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