Tomosynthesis Mammographic Imaging Screening Trial

Breast Cancer Clinical Trial

— TMISTLead-in  

Official title:

Tomosynthesis Mammography Imaging Screening Trial Lead-in

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02616432
• Other study ID #: 001-2014b
• Secondary ID: 410000662
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2014
• Est. completion date: November 2024

Study information

• Verified date: April 2024
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized screening trial to compare the diagnostic accuracy of screening for breast cancer with three-dimensional digital breast tomosynthesis (DBT) plus two-dimensional full-field digital mammography (FFDM) versus FFDM alone.

Description:

The Tomosynthesis Mammography Imaging Screening Trial (TMIST) LEAD-IN is being conducted to ensure that all Eastern Cooperative Oncology Group / American College of Radiology Imaging Network (ECOG/ACRIN) TMIST components are properly functional and to provide an opportunity for fine tuning before launching the full TMIST. The accrual target for TMIST LEAD-IN is 6354 participants (one tenth of the projected enrollment target for TMIST) at three lead-in study sites: 1. Sunnybrook Health Sciences Centre in Toronto, 2. Vancouver (under the auspices of the Screening Mammography Programme of British Columbia) and 3. The Ottawa Hospital.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3065
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Asymptomatic women age 40 and over

• Scheduled for screening mammogram

• Able to tolerate digital breast tomosynthesis and full-field digital mammographic imaging required by protocol

• Willing and able to provide a written informed consent.

Exclusion Criteria:

• Presenting for mammography with symptoms of breast disease

• Have new breast complaints (e.g. lump, nipple discharge)

• Have had a mammogram of both breasts within the last 11 months

• Previous personal history of breast cancer

• Has breast enhancements (e.g. implants or injections)

• Pregnancy or intent to become pregnant.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• Tomosynthesis
Three-dimensional imaging of both breasts in standard CC and MLO views

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Breast Health Centre at BC Women's Hospital + Health Centre	Vancouver	British Columbia
Canada	X-Ray 505 (Under the BCCA Screening Mammography Program of BC)	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Eastern Cooperative Oncology Group

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Accuracy of DBT vs FFDM - AUC under ROC comparison	To compare the diagnostic accuracy using the area under the curve (AUC) score generated by receiver operator characteristic (ROC) analysis of digital breast tomosynthesis plus full-field digital mammography (DBT) versus full-field digital mammography (FFDM) alone for breast cancer screening. The examinations will be interpreted by local Breast Imaging radiologists. Cancer status will be pathologically confirmed. The women would undergo three consecutive screening rounds in the assigned arm followed by one year of standard of care imaging follow-up.	3 year follow-up
Secondary	Recall Rates	To compare the recall rates due to abnormal screening examinations for DBT versus FFDM when used for breast cancer screening.	3 year
Secondary	Interval Cancers	To compare the number of interval cancers missed with DBT versus FFDM use in breast cancer screening.	3 year
Secondary	Prevalence of Breast Cancer Subtypes	To estimate the prevalence of breast cancer subtypes (Luminal A, Luminal B, HER2neu, Basal-like, Claudin-low) by DBT and FFDM, stratified on whether cancers were detected in screening or as interval cancers.	3 year
Secondary	Clinical Characteristics of Cancers	To assess and compare clinical characteristics (e.g. stage, grade, ER, PR, and HER2status) of cancers detected from screening by DBT and FFDM. Approximately 75 genes will be assayed in tumors detected in each arm of the study to evaluate breast cancer molecular subtype.	3 year
Secondary	Reader Studies of variations of DBT vs FFDM - AUC under ROC comparison	To assess different combinations of FFDM, tomosynthesis and synthesized FFDM images in reader studies to assist in determining the optimum balance between radiation exposure and technique. AUC of ROC curves will be used to compare combinations. A panel of radiologists will read the various combinations of images in random order to assess whether tomosynthesis with synthetic 2D images is as accurate as tomosynthesis with FFDM images. The latter will require more radiation exposure.	4 year
Secondary	Biomarker Correlation	Biomarker correlation to characterize disease in the tumor and compare to the tissue immediately adjacent to it.	2 year