Imagio OA/US for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Breast CancerImagio OA/US - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether a new breast cancer imaging system can detect complete breast cancer pathologic responses to neoadjuvant therapy.

Eligible Conditions
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Baseline to Post Surgical Assessment at 6 months

Month 6
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 metastatic lymph nodes scored using a Lymph Node Scoring Scale that may correlate with chemotherapy response
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

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Imagio OA/US
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Imagio OA/US · No Placebo Group · N/A

Imagio OA/US
Device
Experimental Group · 1 Intervention: Imagio OA/US · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imagio OA/US
2015
N/A
~220

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to post surgical assessment at 6 months

Who is running the clinical trial?

Seno Medical Instruments Inc.Lead Sponsor
8 Previous Clinical Trials
3,636 Total Patients Enrolled
5 Trials studying Breast Cancer
2,961 Patients Enrolled for Breast Cancer
American College of RadiologyOTHER
13 Previous Clinical Trials
8,031,229 Total Patients Enrolled
2 Trials studying Breast Cancer
2,187 Patients Enrolled for Breast Cancer
Basak Dogan, MDPrincipal InvestigatorUT Southwestern
2 Previous Clinical Trials
121 Total Patients Enrolled
2 Trials studying Breast Cancer
121 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are male or female.\n
You have invasive breast cancer, including primary or recurrent disease.