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Imaging

Tomosynthesis Screening for Breast Cancer (TMISTLead-in Trial)

N/A
Waitlist Available
Led By Roberta A Jong, MD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Presenting for mammography with symptoms of breast disease
Have new breast complaints (e.g. lump, nipple discharge)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 year
Awards & highlights
No Placebo-Only Group

Summary

This trial found that DBT was more accurate than FFDM in detecting breast cancer.

Who is the study for?
This trial is for asymptomatic women aged 40 and over who are scheduled for a routine screening mammogram. Participants must be able to undergo digital breast tomosynthesis and full-field digital mammography, and provide consent. Women with prior breast cancer, current or planned pregnancy, recent mammograms, breast enhancements, or new breast complaints cannot join.
What is being tested?
The study aims to compare the effectiveness of two types of breast cancer screenings: one combining three-dimensional digital breast tomosynthesis (DBT) with standard two-dimensional full-field digital mammography (FFDM), versus FFDM alone in detecting cancer.
What are the potential side effects?
Digital breast tomosynthesis and full-field digital mammography may involve exposure to low-dose radiation similar to traditional x-rays which carries a minimal risk of harmful effects.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am experiencing symptoms of breast disease and need a mammogram.
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I have noticed new issues with my breast, like a lump or discharge.
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I have had breast cancer before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Diagnostic Accuracy of DBT vs FFDM - AUC under ROC comparison
Secondary study objectives
Biomarker Correlation
Clinical Characteristics of Cancers
Interval Cancers
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Tomosynthesis + FFDMExperimental Treatment1 Intervention
Women enrolled to DBT Arm will undergo manufacturer-defined DBT
Group II: FFDM - Standard of Care for ScreeningActive Control1 Intervention
Women enrolled to the FFDM Arm will undergo bilateral digital mammogram with standard CC and MLO views acquired
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tomosynthesis
2010
N/A
~1000

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
680 Previous Clinical Trials
1,562,801 Total Patients Enrolled
31 Trials studying Breast Cancer
14,077 Patients Enrolled for Breast Cancer
Eastern Cooperative Oncology GroupNETWORK
268 Previous Clinical Trials
148,530 Total Patients Enrolled
30 Trials studying Breast Cancer
43,022 Patients Enrolled for Breast Cancer
Roberta A Jong, MDPrincipal InvestigatorSunnybrook Health Sciences Centre

Media Library

Tomosynthesis (Imaging) Clinical Trial Eligibility Overview. Trial Name: NCT02616432 — N/A
Breast Cancer Research Study Groups: Tomosynthesis + FFDM, FFDM - Standard of Care for Screening
Breast Cancer Clinical Trial 2023: Tomosynthesis Highlights & Side Effects. Trial Name: NCT02616432 — N/A
Tomosynthesis (Imaging) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02616432 — N/A
~274 spots leftby Dec 2025
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