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Abbreviated Breast MRI and Digital Tomosynthesis Mammography in Screening Women With Dense Breasts

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ClinicalTrials.gov Identifier: NCT02933489
Recruitment Status : Active, not recruiting
First Posted : October 14, 2016
Last Update Posted : December 11, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )

Brief Summary:
This randomized phase II trial studies how well abbreviated breast magnetic resonance imaging (MRI) and digital tomosynthesis mammography work in detecting cancer in women with dense breasts. Abbreviated breast MRI is a low cost procedure in which radio waves and a powerful magnet linked to a computer and used to create detailed pictures of the breast in less than 10 minutes. These pictures can show the difference between normal and diseased tissue. Digital tomosynthesis mammography is a procedure that uses multiple x-rays pictures of each breast to produce a 3-dimensional rendering of the entire breast. Combined screening with abbreviated breast MRI and digital tomosynthesis mammography may be a better method to screen women with dense breasts.

Condition or disease Intervention/treatment Phase
Asymptomatic Procedure: Contrast-enhanced Magnetic Resonance Imaging Procedure: Digital Tomosynthesis Mammography Other: Quality-of-Life Assessment Other: Questionnaire Administration Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To compare the rates of detection of invasive cancers between the initial abbreviated breast (AB)-magnetic resonance (MR) and digital tomosynthesis mammography (DBT).

SECONDARY OBJECTIVES:

I. To compare the positive predictive value (PPV) of biopsies, call back rates, and short-term follow up rates after AB-MR and DBT on both the initial and 1 year follow up studies.

II. To estimate and compare the sensitivity and specificity of AB-MR and DBT, using the 1 year follow up to define a reference standard.

III. To compare patient-reported short-term quality of life related to diagnostic testing with AB-MR and DBT using the Testing Morbidities Index.

IV. To compare willingness to return for testing with AB-MRI versus (vs) DBT within the recommended screening interval and explore factors associated with willingness to return for screening.

V. To compare the tumor biologies of invasive cancers and ductal carcinoma in situ (DCIS) detected on AB-MR and DBT.

VI. To estimate the incident cancer rate during 3 years following the year-1 AB-MR/DBT when patients return to standard screening.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM A (DBT, AB-MR): Participants undergo DBT followed by AB-MR for under 10 minutes on the same day or within 24 hours at baseline and then after 1 year.

ARM B (AB-MR, DBT): Participants undergo AB-MR for under 10 minutes followed by DBT on the same day or within 24 hours at baseline and then after 1 year.

After completion of study, patients are followed up at every 6 months for 3 years.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Comparison of Abbreviated Breast MRI and Digital Breast Tomosynthesis in Breast Cancer Screening in Women With Dense Breasts
Actual Study Start Date : September 2, 2016
Estimated Primary Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography

Arm Intervention/treatment
Experimental: Arm A (DBT, AB-MR)
Participants undergo DBT followed by AB-MR for under 10 minutes on the same day or within 24 hours at baseline and then after 1 year.
Procedure: Contrast-enhanced Magnetic Resonance Imaging
Undergo AB-MR
Other Names:
  • CONTRAST ENHANCED MRI
  • Contrast-enhanced MRI

Procedure: Digital Tomosynthesis Mammography
Undergo DBT
Other Names:
  • DBT
  • Digital Breast Tomosynthesis
  • Digital Tomosynthesis of the Breast

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Experimental: Arm B (AB-MR, DBT)
Participants undergo AB-MR for under 10 minutes followed by DBT on the same day or within 24 hours at baseline and then after 1year.
Procedure: Contrast-enhanced Magnetic Resonance Imaging
Undergo AB-MR
Other Names:
  • CONTRAST ENHANCED MRI
  • Contrast-enhanced MRI

Procedure: Digital Tomosynthesis Mammography
Undergo DBT
Other Names:
  • DBT
  • Digital Breast Tomosynthesis
  • Digital Tomosynthesis of the Breast

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Rate of detection of invasive cancers between initial abbreviated breast-magnetic resonance (MR) and digital tomosynthesis mammography (DBT) [ Time Frame: Up to 1 year ]
    For each modality, the detection rate of invasive cancers is defined as the proportion of participants who had an invasive cancer detected by the modality and verified by pathology. The comparison of the invasive cancer detection rates will be made using McNemar?s test.


Secondary Outcome Measures :
  1. Change in call back rates [ Time Frame: Baseline to up to 1 year ]
    For each screening occasion the estimates of call-back rates of two modalities will be compared using McNemar?s test to account for the paired design.

  2. Change in patient-reported short-term quality of life related to diagnostic testing with of abbreviated breast-magnetic resonance (MR) and digital tomosynthesis mammography (DBT) using the Testing Morbidities Index (TMI) [ Time Frame: Baseline to up to 1 year ]
    Separate TMI scores will be computed for each modality after the baseline screen. Scores will be compared using a nonparametric test that accounts for the pairing of scores by participant.

  3. Change in positive predictive value (PPV) of biopsies [ Time Frame: Baseline to up to 1 year ]
    Generalized estimating equation regression modeling will be used in the comparison of PPVs.

  4. Change in sensitivity of abbreviated breast-magnetic resonance (MR) and digital tomosynthesis mammography (DBT) [ Time Frame: Baseline to up to 1 year ]
    The sensitivities of the two modalities will be estimated using a reference standard comprising the information from any subsequent workup and the information from the 1-year follow-up. The information from the year 1 screens will not be included in the reference standard. Estimates will be compared using McNemar?s test to account for the paired design.

  5. Change in short-term follow up rates [ Time Frame: Baseline to up to 1 year ]
    For each screening occasion the estimates of short-term follow-up rates of two modalities will be compared using McNemar?s test to account for the paired design.

  6. Change in specificity of abbreviated breast-magnetic resonance (MR) and digital tomosynthesis mammography (DBT) [ Time Frame: Baseline to up to 1 year ]
    The specificities of the two modalities will be estimated using a reference standard comprising the information from any subsequent workup and the information from the 1-year follow-up. The information from the year 1 screens will not be included in the reference standard. Estimates will be compared using McNemar?s test to account for the paired design.

  7. Ductal carcinoma in situ (DCIS) detected on abbreviated breast-magnetic resonance (MR) and digital tomosynthesis mammography (DBT) [ Time Frame: Up to 1 year ]
    The analysis for will be descriptive. If the Oncotype-DCIS score was performed, the distributions of scores will be tabulated and compared.

  8. Factors associated with willingness to return for screening [ Time Frame: Up to 1 year ]
    Polytomous logistic regression will be used to examine factors associated with willingness to return, including screen result, cancer status, and demographic characteristics.

  9. Incident cancer rate [ Time Frame: Up to 3 years ]
    Breast cancer incidence will be estimated. Person-years will be measured.

  10. Tumor biologies of invasive cancers [ Time Frame: Up to 1 year ]
    The analysis for will be descriptive. The frequencies of cancer types determined by the NanoString analysis will be tabulated and compared.

  11. Willingness to return for testing with abbreviated breast-magnetic resonance (MR) versus digital tomosynthesis mammography (DBT) [ Time Frame: Up to 1 year ]
    The proportions of participants willing to return for screening with either test, AB-MRI only, DBT only, or not willing to return for either test will be estimated.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patents must be scheduled for routine screening DBT
  • Women must not be pregnant or breast-feeding; all females of childbearing potential who are uncertain if they could be pregnant or may be pregnant or as per local site standard of practice in women undergoing DBT and MRI must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • Women of childbearing potential must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the following year until the year 1 AB-MR and DBT studies are performed
  • Patient?s breast density must be known; patients must have mammographically dense breasts, American College of Radiology [ACR] Breast Imaging [BI]- Reporting and Data System Atlas (RADS) lexicon categories c or d (heterogeneous or extreme fibroglandular tissue) on their most-recent prior screening
  • Patient must be asymptomatic for breast disease and undergoing routine screening
  • Patient must have no known breast cancer (DCIS or invasive cancer), not currently undergoing treatment for breast cancer, or planning surgery for a high risk lesion (atypical ductal breast hyperplasia [ADH], atypical lobular breast hyperplasia [ALH], lobular breast carcinoma in situ [LCIS], papilloma, radial scar)
  • Patient must not be taking chemoprevention for breast cancer
  • Patient must not have undergone breast ultrasound within 12 months prior to randomization
  • Patient must not have previously had a breast MRI
  • Patient must not have previously had molecular breast imaging (MBI, multiplexed ion beam imaging [MIBI])
  • Patient must agree to not undergo screening ultrasound (of breast) for the duration of the 1 year study period
  • Patient must not be suspected of being at high-risk for breast cancer, as defined by the American Cancer Society (ACS) breast MR screening recommendations (lifetime risk of >= 20-25%)
  • Patient must be able to undergo breast MRI with contrast enhancement; patients unable to undergo breast MRI with contrast enhancement for any reason are ineligible

    • No history of untreatable claustrophobia
    • No presence of non MR compatible metallic objects or metallic objects that, in the opinion of the radiologist, would make MRI a contraindication
    • No history of sickle cell disease
    • No contraindication to intravenous contrast administration
    • No known allergy-like reaction to gadolinium or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR); patient may be eligible if willing to undergo pre-treatment as defined by the institution's policy and/or ACR guidance
    • No known or suspected renal impairment; requirements for glomerular filtration rate (GFR) prior to MRI as determined by local site standard practice
    • Weight less than or equal to the MRI table limit
    • No women who have had prior contrast enhanced mammography (contrast enhanced spectral mammography [CESM] or contrast enhanced digital mammography [CEDM])
    • No women who have breast prosthetic implants (silicone or saline)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02933489


  Show 68 Study Locations
Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Christopher Comstock ECOG-ACRIN Cancer Research Group

Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT02933489     History of Changes
Other Study ID Numbers: EA1141
NCI-2016-00252 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
s16-01825
EA1141 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
ECOG-ACRIN-EA1141 ( Other Identifier: DCP )
EA1141 ( Other Identifier: CTEP )
UG1CA189828 ( U.S. NIH Grant/Contract )
First Posted: October 14, 2016    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No