Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer



Status:Recruiting
Healthy:No
Age Range:45 - 74
Updated:12/16/2018
Start Date:July 6, 2017
End Date:August 1, 2030

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Tomosynthesis Mammographic Imaging Screening Trial (TMIST)

This randomized phase III trial studies digital tomosynthesis mammography and digital
mammography in screening patients for breast cancer. Screening for breast cancer with
tomosynthesis mammography may be superior to digital mammography for breast cancer screening
and may help reduce the need for additional imaging or treatment.

PRIMARY OBJECTIVES:

I. To compare the proportions of participants in the tomosynthesis mammography (TM) and
digital mammography (DM) study arms experiencing the occurrence of an ?advanced? breast
cancer at any time during a period of 4.5 years from randomization, including the period of
active screening and a period of clinical follow-up after the last screen (T4).

SECONDARY OBJECTIVES:

I. To assess the potential effect of age, menopausal and hormonal status, breast density, and
family cancer history on the primary endpoint difference between the two arms.

II. To compare the diagnostic performance of TM and DM, as measured by the area under the
receiver operating characteristic (ROC) curve (AUC), sensitivity, specificity, positive
predictive value (PPV) and negative predictive value (NPV).

III. To compare the recall rates and biopsy rates for TM versus DM, with subset analyses by
the same variables as listed in aim II.

IV. To compare the rate of interval cancers for TM and DM and to assess the mechanism of
diagnosis for these interval cancers with categorization by symptomatic versus (vs)
asymptomatic, and how detected: diagnosed via physical examination, mammography, ultrasound
(US), magnetic resonance imaging (MRI) or other technologies.

V. To examine the correlation between Breast Imaging Reporting and Data System (BIRADS)
imaging features and histologic and genetic features, such as invasive ductal and invasive
lobular histology, high grade, high stage at diagnosis, and aggressive genetic subtypes.

VI. To assess different combinations of TM and synthesized 2 dimensional (2D) or DM in reader
studies to assist in determining the optimum balance between diagnostic performance,
radiation exposure and technique.

VII. To estimate and compare breast-cancer-specific mortality between the two study arms.

VIII. To estimate and compare the prevalence of breast cancer subtypes (luminal A, luminal B,
HER2+, basal-like) low, medium or high proliferation via PAM50 proliferation signatures, and
p53 mutant-like or wild-type-like according to a validated p53 dependent signature in the two
arms, overall and stratified on whether cancers were detected through screening or as
interval cancers, and whether cancers were invasive or in situ.

IX. To classify histologically malignant (true positive cases) and benign lesions (false
positive cases) as normal-like or tumor-like using the PAM50 gene expression assay subtype
(luminal A, luminal B, HER2, basal-like,), and low, medium, or high proliferation according
to PAM50 proliferation signatures, and p53 mutant-like or wild-type-like according to a
validated p53-dependent signature.

X. To assess the agreement between local and expert study pathologists for all breast lesions
(benign and malignant) biopsied during the 4.5 years of screening with TM or DM.

XI. To create a blood and buccal cell biobank for future biomarker and genetic testing.

XII. To compare health care utilization (including cancer care received) and cost of an
episode of breast cancer screening by TM versus DM, overall and within subsets.

XIII. To implement a centralized quality control (QC) monitoring program for both 2D digital
mammography (DM) and tomosynthesis (TM), which provides rapid feedback on image quality,
using quantitative tools, taking advantage of the automated analysis of digital images.

XIV. To assess temporal and site-to site variations in image quality, breast radiation dose,
and other quality control parameters in TM vs. DM.

XV. To refine and implement task-based measures of image quality to assess the effects of
technical parameters, including machine type, and detector spatial and contrast resolution on
measures of diagnostic accuracy for TM.

XVI. To evaluate which QC tests are useful for determination of image quality and those that
are predictive of device failure, in order to recommend an optimal QC program for TM.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients undergo bilateral screening DM with standard craniocaudal (CC) and
mediolateral oblique (MLO) views at baseline, 12, 24, 36, and 48 months if pre-menopausal or
at baseline, 24, and 48 months if post-menopausal.

ARM B: Patients undergo manufacturer-defined screening TM at baseline, 12, 24, 36, and 48
months if pre-menopausal or at baseline, 24, and 48 months if post-menopausal.

After completion of study, patients are followed up for at least 4.5-8 years after study
entry.

Inclusion Criteria:

- Women of childbearing potential must not be known to be pregnant or lactating

- Patients must be scheduled for, or have intent to schedule, a screening mammogram

- Patients must be able to tolerate digital breast tomosynthesis and full-field digital
mammographic imaging required by protocol, to be performed at an American College of
Radiology Imaging Network (ACRIN)-qualified facility

- Patients must be willing and able to provide a written informed consent

- Patients must not have symptoms or signs of benign or malignant breast disease (eg,
nipple discharge, breast lump) warranting a diagnostic rather than a screening
mammogram, and/or other imaging studies (eg, sonogram); patients with breast pain are
eligible as long as other criteria are met

- Patients must not have had a screening mammogram within the last 11 months prior to
date of randomization

- Patients must not have previous personal history of breast cancer including ductal
carcinoma in situ

- Patients must not have breast enhancements (e.g., implants or injections)

- ANNUAL SCREENING REGIMEN ELIGIBILITY CHECK

- To be eligible for inclusion in the annual screening regimen one of the following
three conditions must be met in addition to the eligibility criteria above:

- Patients are pre-menopausal; OR

- Post-menopausal aged 45-69 with any of the following three risks factors:

- Dense breasts (BIRADS density categories c-heterogeneously dense or
d-extremely dense), or

- Family history of breast cancer (first degree relative with breast cancer),
or, positive genetic testing for any deleterious genes that indicate an
increased risk for breast cancer, or

- Currently on hormone therapy; OR

- Post-menopausal ages 70-74 with either of the following two risk factors:

- Dense breasts (BIRADS density categories c-heterogeneously dense or
d-extremely dense), or

- Currently on hormone therapy

- Postmenopausal women are defined as those with their last menstrual period more than
12 months prior to study entry; for the purpose of defining menopausal status for
women who have had surgical cessation of their periods, women who no longer have
menses due to hysterectomy and oophorectomy will be considered postmenopausal; women
who no longer have menses due to hysterectomy without oophorectomy will be considered
premenopausal until age 52 and postmenopausal thereafter

- All other postmenopausal women are eligible for inclusion in the biennial screening
regimen

- For those women who cannot be assigned to annual or biennial screening at the time of
study entry and randomization because they are postmenopausal, have no family history
or known deleterious breast cancer mutation, are not on hormone therapy AND have not
had a prior mammogram, breast density will be determined by the radiologist?s
recording of it at the time of interpretation of the first study screening
examination, either DM or TM; for those who are randomized to TM, radiologists will
assign BI-RADS density through review of the DM or synthetic DM portion of the TM
examination; such women cannot be part of the planned stratification by screening
frequency and are expected to represent far less than 1% of the Tomosynthesis
Mammographic Imaging Screening Trial (TMIST) population

- Breast density will be determined by prior mammography reports, when available; all
other risk factors used to determine patient eligibility for annual or biennial
screening will be determined by subject self-report
We found this trial at
63
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602 W University Ave
Urbana, Illinois 61801
(217) 383-3010
Principal Investigator: Kendrith M. Rowland
Phone: 800-446-5532
Carle Cancer Center Carle Cancer Center delivers comprehensive care through leading-edge technology and advanced research,...
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
Principal Investigator: Ursa A. Brown-Glaberman
Phone: 505-925-0366
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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1300 Jefferson Park Avenue
Charlottesville, Virginia 22908
434-243-6784
Principal Investigator: Jennifer A. Harvey
Phone: 434-243-6303
University of Virginia Cancer Center We are fortunate in having state of the art clinical...
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
Principal Investigator: Stephanie Patterson
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-3456
Principal Investigator: Philip J. Stella
Phone: 734-712-3671
Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
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Appleton, Wisconsin 54911
Principal Investigator: Susan Sung
Phone: 844-510-3600
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
Principal Investigator: Lynn D. Baxter
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Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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12605 East 16th Avenue
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720-848-0000
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Bakersfield, California 93306
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Baton Rouge, Louisiana 70815
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100 E Idaho St
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Braselton, Georgia 30517
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Bronx, New York 10461
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2600 Sixth St. SW
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330.363.4908
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Carson City, Nevada 89703
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Chapel Hill, North Carolina 27599
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1969 W Ogden Ave
Chicago, Illinois 60612
(312) 864-6000
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2300 N Edward St
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3773 Chry Crk North Dr # 101
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1111 6th Ave
Des Moines, Iowa 50314
(515) 247-3121
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Mercy Medical Center - Des Moines Mercy Medical Center
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Duluth, Minnesota 55805
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2301 Erwin Rd
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1301 Punchbowl St
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535 Barnhill Dr
Indianapolis, Indiana 46202
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600 Highland Ave
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Memphis, Tennessee 38120
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Memphis, Tennessee 38120
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Minneapolis, Minnesota 55414
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1600 Midtown Avenue
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254 Easton Ave
New Brunswick, New Jersey 08901
(732) 745-8600
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1275 York Ave
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445 E 69th St
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Newark, Delaware 19713
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600 Gresham Dr
Norfolk, Virginia 23507
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320 E North Ave
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1 Medical Center Blvd
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336-716-2011
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Worcester, Massachusetts 01655
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