Your session is about to expire
← Back to Search
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
Scheduled for screening mammogram
Asymptomatic women age 40 and over
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 year
Awards & highlights
TMISTLead-in Trial 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.Check my eligibility
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.See study design
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.
TMISTLead-in Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a screening mammogram.
Select...
I am a woman over 40 and do not have any symptoms.
TMISTLead-in Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Diagnostic Accuracy of DBT vs FFDM - AUC under ROC comparison
Secondary outcome measures
Biomarker Correlation
Clinical Characteristics of Cancers
Interval Cancers
+3 moreTMISTLead-in 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
655 Previous Clinical Trials
1,547,997 Total Patients Enrolled
29 Trials studying Breast Cancer
13,836 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for a screening mammogram.I am a woman over 40 and do not have any symptoms.I am experiencing symptoms of breast disease and need a mammogram.I have noticed new issues with my breast, like a lump or discharge.You have had breast implants or injections.I have had breast cancer before.
Research Study Groups:
This trial has the following groups:- Group 1: Tomosynthesis + FFDM
- Group 2: FFDM - Standard of Care for Screening
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any new openings in this experiment?
"This research endeavour, initially posted on October 1st 2014 and last amended November 11th 2021, is not currently recruiting patients. However, 1404 other studies are actively searching for participants at this time."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger