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OA for Breast Cancer NAC Response

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ClinicalTrials.gov Identifier: NCT05337280
Recruitment Status : Recruiting
First Posted : April 20, 2022
Last Update Posted : April 27, 2022
American College of Radiology
Information provided by (Responsible Party):
Seno Medical Instruments Inc.

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 response to neoadjuvant therapy as assessed by functional optoacoustic features, vascular features and relative degrees of oxygenation/deoxygenation

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Imagio OA/US Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: This is a single center sequential design
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Feasibility of Assessing Breast Cancer Neoadjuvant Therapy Response Using Imagio Opto-Acoustic Imaging
Actual Study Start Date : March 30, 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Imagio OA/US
Imagio OA/US Imaging
Device: Imagio OA/US
Imagio optoacoustic/ultrasound

Primary Outcome Measures :
  1. 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

  2. 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.

Other Outcome Measures:
  1. 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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 18 years and older male or female patients;
  2. Ipsilateral intact biopsy-proven invasive breast cancer clinical T1-T4 (by standard of care imaging), including primary or recurrent disease.
  3. Patient eligible to receive neoadjuvant chemotherapy

Exclusion Criteria:

  1. Known Stage IV disease (breast or other cancer);
  2. 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);
  3. Patient has received chemotherapy for any type of cancer within 90 days from date of baseline Imagio OA/US exam;
  4. Is experiencing photo-toxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as sulfa, ampicillin, tetracycline;
  5. Is currently undergoing phototherapy;
  6. Has a history of any photosensitive disease (e.g., porphyria, lupus erythematosus);
  7. Is undergoing treatment for a photosensitive disease and is experiencing photosensitivity;
  8. Pregnancy;
  9. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05337280

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Contact: Shaan Schaeffer, BA 6106983259 sschaeffer@senomedical.com

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United States, Texas
UT Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Basak Dogan, MD    214-645-3290    basak.dogan@utsothwestern.edu   
Contact: Keshia Anerobi    214-648-5982    keshia.anerobi@utsouthwestern.edu   
Principal Investigator: Basak Dogan, MD         
Sponsors and Collaborators
Seno Medical Instruments Inc.
American College of Radiology
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Principal Investigator: Basak Dogan, MD UT Southwestern
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Responsible Party: Seno Medical Instruments Inc.
ClinicalTrials.gov Identifier: NCT05337280    
Other Study ID Numbers: NEO-01
First Posted: April 20, 2022    Key Record Dates
Last Update Posted: April 27, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases