Status:
COMPLETED
OA for Breast Cancer NAC Response
Lead Sponsor:
Seno Medical Instruments Inc.
Collaborating Sponsors:
American College of Radiology
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is an early research and development study. The objective of this study is to determine the feasibility of the Imagio OA/US Breast Imaging System to detect complete breast cancer pathologic respo...
Detailed Description
The use of neoadjuvant systemic therapy in the treatment of breast cancer patients is increasing beyond the scope of locally advanced disease. Imaging provides important information in assessing respo...
Eligibility Criteria
Inclusion
- 18 years and older male or female patients;
- Ipsilateral intact biopsy-proven invasive breast cancer clinical T1-T4 (by standard of care imaging), including primary or recurrent disease.
- Patient eligible to receive neoadjuvant chemotherapy
Exclusion
- Known Stage IV disease (breast or other cancer);
- Have a condition or impediment (i.e., insect bites, poison ivy, open sores, chafing of the skin, scar, tattoos, moles, etc.); that could interfere with the intended field of view (within one probe length or 4 cm of the nodule);
- Patient has received chemotherapy for any type of cancer within 90 days from date of baseline Imagio OA/US exam;
- Is experiencing photo-toxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as sulfa, ampicillin, tetracycline;
- Is currently undergoing phototherapy;
- Has a history of any photosensitive disease (e.g., porphyria, lupus erythematosus);
- Is undergoing treatment for a photosensitive disease and is experiencing photosensitivity;
- Pregnancy;
- Patient has participated in a clinical study of an investigational drug or device within 3 months prior to screening visit that may have an impact on clinical outcomes.
Key Trial Info
Start Date :
March 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05337280
Start Date
March 30 2021
End Date
January 4 2023
Last Update
April 12 2023
Active Locations (1)
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1
UT Southwestern
Dallas, Texas, United States, 75390