OA for Breast Cancer NAC Response

NCT05337280 | Completed FDA Device

• 1 other identifier: NEO-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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

  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

  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 Outcomes (1)

• Number of metastatic lymph nodes scored using a Lymph Node Scoring Scale that may correlate with chemotherapy response

  Baseline to Post Surgical Assessment at 6 months

Study Arms (1)

Imagio OA/US

EXPERIMENTAL

Imagio OA/US Imaging

Device: Imagio OA/US

Interventions

Imagio OA/US DEVICE

Imagio optoacoustic/ultrasound

Imagio OA/US

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seno Medical Instruments Inc.: lead
• American College of Radiology: collaborator

Study Sites (1)

UT Southwestern

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Basak Dogan, MD

  UT Southwestern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a single center sequential design

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: April 20, 2022
• Study Start: March 30, 2021
• Primary Completion: January 4, 2023
• Study Completion: January 4, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)