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MBI vs DBT Screening for Dense Breast Tissue in Breast Cancer (MBI-DBT Trial)

N/A
Waitlist Available
Led By Carrie B. Hruska, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is a consenting female age 40-75 years
Patient is asymptomatic for breast disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at year 1 screening
Awards & highlights

MBI-DBT Trial Summary

This trial compares the effectiveness of two breast cancer screening methods: molecular breast imaging (MBI) and digital breast tomosynthesis (DBT).

Who is the study for?
This trial is for women aged 40-75 with dense breast tissue who are not pregnant, haven't had certain prior breast screenings or biopsies recently, and aren't currently on treatments for breast cancer or high-risk lesions. Participants must be able to return for a follow-up after one year and give informed consent.Check my eligibility
What is being tested?
The study compares molecular breast imaging (MBI), which uses a radioactive injection to detect active changes in tissues, with digital breast tomosynthesis (DBT), an advanced form of mammography. It aims to determine if MBI can better identify cancers in dense breasts than DBT.See study design
What are the potential side effects?
Possible side effects from MBI include reactions to the radioactive material such as rash or discomfort at the injection site. DBT has minimal side effects but may involve discomfort during the procedure.

MBI-DBT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman aged between 40 and 75 and agree to participate.
Select...
I do not have symptoms from my breast condition.

MBI-DBT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at year 1 screening
This trial's timeline: 3 weeks for screening, Varies for treatment, and at year 1 screening for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in advanced cancer rate with incorporation of MBI screening
Characteristics of all cancers (invasive and noninvasive) detected on DBT and MBI
Rate of detection of invasive cancers
+7 more

MBI-DBT Trial Design

1Treatment groups
Experimental Treatment
Group I: Observational (MRI, DBT)Experimental Treatment2 Interventions
Participants undergo DBT and MBI at year 0 and year 1 screening.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Digital Tomosynthesis Mammography
2017
N/A
~140

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,922,757 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,765,408 Total Patients Enrolled
83 Trials studying Breast Cancer
13,912 Patients Enrolled for Breast Cancer
Carrie B. Hruska, M.D.Principal InvestigatorMayo Clinic in Rochester

Media Library

Digital Breast Tomosynthesis Clinical Trial Eligibility Overview. Trial Name: NCT03220893 — N/A
Breast Cancer Research Study Groups: Observational (MRI, DBT)
Breast Cancer Clinical Trial 2023: Digital Breast Tomosynthesis Highlights & Side Effects. Trial Name: NCT03220893 — N/A
Digital Breast Tomosynthesis 2023 Treatment Timeline for Medical Study. Trial Name: NCT03220893 — N/A

Frequently Asked Questions

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

Could you explain the age restrictions for this trial?

"People who meet the age requirement of 40 to 75 years old can apply to be a part of this clinical trial. Out of the 2677 total studies, 76 are for people under 18 and 2601 are for seniors above 65."

Answered by AI

Who does this clinical trial cater to?

"Up to 3000 patients will be included in this research, provided they are female, aged 40-75, have breast cancer, and meet the other listed prerequisites. If a patient meets these conditions and consents to participate in the study, they will undergo routine screening DBT as well as yearly check-ups for data collection purposes."

Answered by AI

How many patients will be included in this experiment?

"Yes, this is an ongoing study that is looking for 3000 patients from 3 different locations. The listing on clinicaltrials.gov shows that the trial was first posted on 6/14/2017 and was last updated on 5/25/2022."

Answered by AI

Are new participants being enrolled in this clinical trial at this time?

"That is accurate, the website provides current information that this study is still seeking volunteers. The listing was first put up on 6/14/2017 and was last updated on 5/25/2022. They are looking for 3000 participants to be divided among 3 locations."

Answered by AI

Who else is applying?

What site did they apply to?
Henry Ford Hospital
What portion of applicants met pre-screening criteria?
Met criteria
~100 spots leftby Sep 2024