Abbreviated Breast MRI and Digital Tomosynthesis Mammography in Screening Women With Dense Breasts
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| ClinicalTrials.gov Identifier: NCT02933489 |
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Recruitment Status :
Active, not recruiting
First Posted : October 14, 2016
Results First Posted : February 5, 2021
Last Update Posted : November 9, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Asymptomatic | Diagnostic Test: Contrast-enhanced Magnetic Resonance Imaging Diagnostic Test: Digital Tomosynthesis Mammography Other: Quality-of-Life Assessment Other: Questionnaire Administration | Not Applicable |
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) |
| Actual Enrollment : | 1516 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 : | December 27, 2016 |
| Actual Primary Completion Date : | January 23, 2020 |
| Estimated Study Completion Date : | March 2022 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Diagnostic Test: Contrast-enhanced Magnetic Resonance Imaging
Undergo AB-MR
Other Names:
Diagnostic Test: Digital Tomosynthesis Mammography Undergo DBT
Other Names:
Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies |
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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.
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Diagnostic Test: Contrast-enhanced Magnetic Resonance Imaging
Undergo AB-MR
Other Names:
Diagnostic Test: Digital Tomosynthesis Mammography Undergo DBT
Other Names:
Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies |
- Screen-detected Invasive Cancer Verified by Pathology [ 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 at baseline and verified by pathology versus the total number of participants. In the out come measures table below, these proportions will be automatically calculated, multiplied by 100, and be presented as percentages (%).
- Prediction of Breast Cancer (Sensitivity and Specificity) [ Time Frame: Baseline to up to 1 year ]
Reference standard positive (RS+): breast cancer (invasive or DCIS) detected on the year 0 screening or reported at any time from the year 0 to the year 1 screening.
Reference standard negative (RS-): No breast cancer reported at any time from the year 0 to the year 1 screen.
Incomplete: No Year 1 imaging, and <11 months of patient follow-up (<330 days) after year 0 screen
Positive Test (T+) is defined as the imaging modality result is positive (BI-RADS 3-5), and the location of the finding is matches the location of the cancer indicated by the reference standard.
Negative Test (T-) will be estimated as the fraction of reference standard negative subjects for whom the imaging modality result was negative (BI-RADS 1-2).
95% confidence intervals for the sensitivity and specificity of each modality calculated using the Wilson method.
- Positive Predictive Value (PPV) of Biopsies [ Time Frame: Baseline to up to 1 year ]
Test Positive (T+): Biopsy recommended by imaging, defined as patients with at least one lesion rated BI-RADS 4 or 5 on image interpretation. Reference Standard Positive (RS+): Pathologically confirmed DCIS or invasive disease resultant from a positive test.
The 95% confidence interval for PPV of biopsy for each modality were derived from the GEE model using the appropriate estimable contrasts with robust standard errors
- Call Back/Additional Imaging/Short-term Follow Rates for DBT and AB-MR [ Time Frame: Baseline ]
For DBT:
DBT: Call back is defined as having additional views or targeted ultrasound to evaluate DBT findings DBT: short term follow up (STFU) is defined as having at least one lesion rated BI-RADS 3 on DBT DBT: Additional imaging recommendation is defined as having either call back or STFU
For AB-MR:
Ab-MR: Call back does not apply to AB-MR and will not be evaluated Ab-MR: Short Term Follow-up (STFU) is defined as having at least one lesion rated BI-RADS 3 on AB-MR Ab-MR: Additional imaging recommendation is defined as having a STFU
- 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.
A low risk score is less than 39, and a high risk score is 55 or higher. A score of 39 to 54 is intermediate risk.
- Incident Cancer Rate [ Time Frame: Up to 3 years ]Breast cancer incidence will be estimated. Person-years will be measured.
- 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.
- 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.
- Change in Patient-reported Short-term Quality of Life Related to Diagnostic Testing [ Time Frame: Baseline to up to 1 year ]Separate Testing Morbidities Index (TMI) scores will be computed for abbreviated breast-magnetic resonance (MR) and digital tomosynthesis mammography (DBT) after the baseline screen. Scores will be compared using a nonparametric test that accounts for the pairing of scores by participant.
- 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.
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| Ages Eligible for Study: | 40 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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%)
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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) Exclusion Criteria
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
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| Principal Investigator: | Christopher Comstock | ECOG-ACRIN Cancer Research Group |
Documents provided by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):
Publications of Results:
| Responsible Party: | ECOG-ACRIN Cancer Research Group |
| ClinicalTrials.gov Identifier: | NCT02933489 |
| Other Study ID Numbers: |
EA1141 NCI-2016-00252 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) s16-01825 ( Other Identifier: Other ) 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 |
| Results First Posted: | February 5, 2021 |
| Last Update Posted: | November 9, 2021 |
| Last Verified: | October 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
| Time Frame: | With publication |
| URL: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7276668/bin/NIHMS1578579-supplement-Supplement_I.docx |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |