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Imaging Device

Imagio OA/US for Breast Cancer

N/A

Waitlist Available

Led By Basak Dogan, MD

Research Sponsored by Seno Medical Instruments Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to post surgical assessment at 6 months

Awards & highlights

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to post surgical assessment at 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to post surgical assessment at 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to post surgical assessment at 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Other outcome measures

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Imagio OA/USExperimental Treatment1 Intervention

Imagio OA/US Imaging

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Imagio OA/US

2015

N/A

~410

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Who is running the clinical trial?

Seno Medical Instruments Inc.Lead Sponsor

8 Previous Clinical Trials

3,201 Total Patients Enrolled

5 Trials studying Breast Cancer

2,961 Patients Enrolled for Breast Cancer

American College of RadiologyOTHER

22 Previous Clinical Trials

8,054,226 Total Patients Enrolled

2 Trials studying Breast Cancer

2,187 Patients Enrolled for Breast Cancer

Basak Dogan, MDPrincipal InvestigatorUT Southwestern

2 Previous Clinical Trials

27 Total Patients Enrolled

2 Trials studying Breast Cancer

27 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still able to join the trial at this time?

"This medical trial, which was initially posted on March 30th 2021, is recruiting patients at this time. The most recent update to the study occurred on April 19th 2022."

Answered by AI

To what extent is this research project including participants?

"Affirmative. Clinicaltrials.gov has verified that this clinical trial, first published on March 30th 2021 is actively recruiting participants across one site with a goal of 20 enrollees. The study was most recently updated on April 19th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

OA for Breast Cancer NAC Response

2021. "OA for Breast Cancer NAC Response". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05337280.