- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05337280
OA for Breast Cancer NAC Response
Feasibility of Assessing Breast Cancer Neoadjuvant Therapy Response Using Imagio Opto-Acoustic Imaging
Study Overview
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 response to therapy as a complement to conventional tumor measurements via physical examination. Tumor response to neoadjuvant therapy can also provide prognostic information. As stated in the background section, the attainment of pCR after completion of neoadjuvant therapy and surgical resection is associated with improved disease-free survival [1-3]. This correlation is especially strong for Triple-receptor negative (ER, PR negative and HER-2 non amplified), and HER-2 positive breast cancer. Studies of neoadjuvant therapy have used a variety of methods for assessing tumor response. Currently, there are no established clinical practice guidelines for how best to assess tumor response to neoadjuvant therapy. Typically, patients undergo conventional breast imaging (mammography and US) and physical examination, and DCE-MRI in selected cases.
The Imagio OA/US technology is an alternative imaging technology that demonstrates both gray scale ultrasound morphologic information, including size measurements, and functional information that includes presence or absence of tumor angiogenesis, degree of angiogenesis, and relative degrees of oxygenation and deoxygenation of hemoglobin.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shaan Schaeffer, BA
- Phone Number: 6106983259
- Email: sschaeffer@senomedical.com
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75390
- Ut Southwestern
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Imagio OA/US
Imagio OA/US Imaging
|
Imagio optoacoustic/ultrasound
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number of masses that may exhibit qualitative changes in accordance with Functional Feature Scale as assessed by Imagio OA/US over the course of baseline though follow-up timepoints
Time Frame: Baseline to Post Surgical Assessment at 6 months
|
Feature scores per mass derived per Feature Score Scale (0-6 and 0-5 scoring- lower score mean most likely benign) per 5 mass features (External Peripheral Zone, External Capsular Boundary, Internal Shape, Internal Echotexture, Internal Sound ) used to predict number of masses that demonstrated response or no response at all time points (baseline, cycle 2, mid cycle and pre surgical) to chemotherapy treatment
|
Baseline to Post Surgical Assessment at 6 months
|
Number of masses that correlate with chemotherapy response/no response as assessed by Functional Feature Score Scale at all study timepoints to predict optimal timing for Imagio imaging
Time Frame: Baseline to Post Surgical Assessment at 6 months
|
Number of masses assessed at baseline and follow-up timepoints - cycle 2, mid cycle and pre surgical f/u that correlate with feature score (External Peripheral Zone, External Capsular, Internal Vessel Score, Internal Total Hemoglobin, Internal Deoxygenated Blush) changes assessed by Feature Score Scale (0-6 nd 0-5 scores depending on feature) and pathologic complete response (pCR) to determine optimal timing for imaging.
|
Baseline to Post Surgical Assessment at 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of metastatic lymph nodes scored using a Lymph Node Scoring Scale that may correlate with chemotherapy response
Time Frame: Baseline to Post Surgical Assessment at 6 months
|
Imagio OA/US imaging of metastatic lymph nodes will be assessed using a designated Lymph Node Scale (Shape Score, Cortical Thickness, Margin Score and Hilar Compression Score, Size Score) to predict response(0 = benign / 1 = benign, uncertain / 2-4 = probably malignant / >=5 = malignant) to chemotherapy
|
Baseline to Post Surgical Assessment at 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEO-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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