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DBT-TOBI Imaging for Monitoring Chemotherapy Response in Breast Cancer

N/A

Waitlist Available

Led By Steven J Isakoff, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Participants must have measurable disease, defined as at least one lesion that can be accurately measured as ≥10 mm in the longest diameter with breast MRI, mammography or ultrasound. See Section 11 for the evaluation of measurable disease.

Female

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4-6 months

Awards & highlights

Study Summary

This trial is testing if DBT-TOBI can show how well chemotherapy works for two types of breast cancer: triple negative and HER2-positive.

Who is the study for?

This trial is for women over 18 with measurable triple negative or HER2+ breast cancer, who are getting neoadjuvant chemotherapy at MGH. They must understand and sign consent. Exclusions include open breast wounds, recent surgery or biopsy, implants, pregnancy intent, certain medical/psychiatric risks, and MRI-specific criteria like claustrophobia or metal in the body.Check my eligibility

What is being tested?

The study tests if DBT-TOBI scans can predict how well triple negative or HER2+ breast cancers respond to pre-surgery chemo. It combines a 3D mammogram with near-infrared imaging to monitor changes in the tumor during treatment.See study design

What are the potential side effects?

Since this trial involves diagnostic imaging techniques rather than drugs, typical side effects associated with medications aren't expected. However, discomfort from positioning during scanning and potential allergic reactions to contrast agents used in optional MRI studies may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a tumor in my breast that is at least 10 mm large.

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I am female.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4-6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4-6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-6 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

Determining whether DBT-TOBI total hemoglobin concentration measurements before cycle 3 of chemotherapy can predict pathological complete response (pCR) versus non-complete responses in breast cancer.

Secondary outcome measures

Pharmacotherapy

Determining whether DBT-TOBI total hemoglobin concentration measurements before the cycle 2 and after changing chemotherapy can predict pathological complete response (pCR) versus non-complete responses in breast cancer.

Determining whether other optical parameters measured by DBT-TOBI are predictive of the final pathologic response after neoadjuvant therapy.

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: DBT-TOBIExperimental Treatment2 Interventions

Subjects will be imaged using DBT-TOBI at the time points indicated in the Study Calendar (Baseline, before cycle 2, and additional optional time points). Both breasts will be measured in turn. Each breast is symmetrically centered on the x-ray detector/optical illuminator and is first compressed according to standard mammography procedures to determine the amount of force needed for each given patient An optional Magnetic Resonance Imaging TOBI (MRI-TOBI) scan will also be performed.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,687 Previous Clinical Trials

40,930,341 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,366 Patients Enrolled for Breast Cancer

Massachusetts General HospitalLead Sponsor

2,937 Previous Clinical Trials

13,199,020 Total Patients Enrolled

80 Trials studying Breast Cancer

132,882 Patients Enrolled for Breast Cancer

Steven J Isakoff, MD5.03 ReviewsPrincipal Investigator - Massachusetts General Hospital

Massachusetts General Hospital

1 Previous Clinical Trials

32 Total Patients Enrolled

1 Trials studying Breast Cancer

32 Patients Enrolled for Breast Cancer

5Patient Review

Excellent. Smart, informative, concerned.

Media Library

DBT-TOBI Clinical Trial Eligibility Overview. Trial Name: NCT03822312 — N/A

Breast Cancer Research Study Groups: DBT-TOBI

Breast Cancer Clinical Trial 2023: DBT-TOBI Highlights & Side Effects. Trial Name: NCT03822312 — N/A

DBT-TOBI 2023 Treatment Timeline for Medical Study. Trial Name: NCT03822312 — N/A

Frequently Asked Questions

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

Can new patients still sign up for this experiment?

"Yes, this is an ongoing study that is currently recruiting patients. The first posting was on February 1st, 2019 with the most recent update on May 6th, 2021. They are looking for a total of 60 participants from 1 site."

Answered by AI

How many people are included in the research project?

"That is correct, the online information about this trial confirms that it is still looking for participants. This study was first advertised on February 1st, 2019 and updated May 6th, 2021. They need a total of 60 patients from just 1 site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Pilot Study of Tomographic Optical Breast Imaging (DBT-TOBI) to Monitor Response to Neoadjuvant Therapy

Steven J Isakoff, MD, PhD 2019. "A Pilot Study of Tomographic Optical Breast Imaging (DBT-TOBI) to Monitor Response to Neoadjuvant Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03822312.

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