Trial Title:
Biennial CEM in Women with a Personal History of Breast Cancer
NCT ID:
NCT06105749
Condition:
Breast Cancer
Breast Neoplasms
Breast Cancer Female
Neoplasms
Conditions: Official terms:
Breast Neoplasms
Neoplasms
Conditions: Keywords:
Breast cancer screening
Digital Breast Tomosynthesis
Contrast-Enhanced Mammogram
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
contrast-enhanced mammography
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
contrast-enhanced mammography
Description:
Contrast-enhanced mammography (CEM) is a new FDA-approved exam that is similar to
magnetic resonance imaging (MRI) in depicting breast cancers due to increased and leaky
blood vessels. Contrast-enhanced mammography is used as an adjunct following mammography
and/or ultrasound examinations to localize a known or suspected lesion.
Arm group label:
contrast-enhanced mammography
Summary:
This is a prospective clinical trial that will examine if biennial contrast-enhanced
mammography added to annual 3D mammography (tomosynthesis) substantially improves breast
cancer detection with minimal increase in false-positives, in women with a personal
history of breast cancer.
Detailed description:
The investigators seek to determine if improved breast cancer detection is maintained
with biennial contrast-enhanced mammography (CEM) added to annual digital breast
tomosynthesis (DBT) with overall fewer false positives than from annual DBT plus CEM. The
investigators will offer biennial CEM exams for eligible patients. Enrolled participants
will have a baseline CEM exam with their routine DBT exam, and then have another CEM exam
24 months after their baseline CEM exam and then again at 48 months. Participants will
continue to have their annual DBT exams during this time as a part of their usual care.
Two radiologists (one primary) will evaluate each pair of examinations by sequentially
interpreting each of DBT and CEM in opposing order (primary reader DBT then CEM and
secondary reader CEM then DBT), initially blinded to the other modality. We expect that
with biennial screening, at least a similar number of cancers will be detected with CEM
(and possibly more that were occult on the DBT-only screen 12 months prior), with a
similar incremental false-positive rate and at least similar (if not improved) overall
positive predictive value (PPV1).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Asymptomatic women, ages 30-79, with a personal history of breast cancer who are at
least one year out from any breast cancer surgery and/or treatment and are scheduled
to have a routine annual mammogram with tomosynthesis (DBT).
Exclusion Criteria:
- Women with a history of prior moderate or severe iodinated contrast reaction [only
those with a prior mild reaction that can be managed by pre-medication AND with and
a strong desire to participate will be allowed to participate. However, among these
women with a mild sensitivity, if they are allergic to Benadryl (one of the
premedications), they will be excluded].
- Women with implant(s) in the breasts to be screened (as this creates artifacts and
diagnostic performance of imaging in women with implants likely does not generalize
to those without implants, and the sample size with implants would be too small to
infer conclusions.
- Women who have had bilateral mastectomy
- Women with a history of kidney failure or estimated glomerular filtration rate
(eGFR) < 45 mL/min
- Pregnancy or lactation
- Women actively being treated for cancer of any type with chemotherapy
- Having only one kidney
- Women with stage 4 metastasis to visceral areas or brain
- Women who have a screening breast MRI exam within 24 months prior to the current
round of CEM.
- Women who had a CEM exam within the prior 23 months
Gender:
Female
Minimum age:
30 Years
Maximum age:
79 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
UPMC Magee-Womens Imaging - Bethel Park
Address:
City:
Bethel Park
Zip:
15102
Country:
United States
Status:
Recruiting
Contact:
Last name:
McKenna Rigling, MS
Phone:
412-641-8278
Email:
riglingmm@upmc.edu
Contact backup:
Last name:
Maegan Johnson, RN
Phone:
412-641-8283
Email:
johnsonme15@upmc.edu
Contact backup:
Last name:
Wendie Berg, MD, PhD
Facility:
Name:
UPMC Magee at the Lemieux Sports Complex
Address:
City:
Cranberry Township
Zip:
16066
Country:
United States
Status:
Recruiting
Contact:
Last name:
McKenna Rigling, MS
Phone:
412-641-8278
Email:
riglingmm@upmc.edu
Contact backup:
Last name:
Maegan Johnson, RN
Phone:
412-641-8283
Email:
johnsonme15@upmc.edu
Contact backup:
Last name:
Wendie Berg, MD, PhD
Facility:
Name:
Magee Womancare Monroeville
Address:
City:
Monroeville
Zip:
15146
Country:
United States
Status:
Recruiting
Contact:
Last name:
McKenna Rigling, MS
Phone:
412-641-8278
Email:
riglingmm@upmc.edu
Contact backup:
Last name:
Maegan Johnson, RN
Phone:
412-641-8283
Email:
johnsonme15@upmc.edu
Contact backup:
Last name:
Wendie Berg, MD, PhD
Facility:
Name:
Magee-Womens Hospital
Address:
City:
Pittsburgh
Zip:
15213
Country:
United States
Status:
Recruiting
Contact:
Last name:
McKenna Rigling, MS
Phone:
412-641-8278
Email:
riglingmm@upmc.edu
Contact backup:
Last name:
Maegan Johnson, RN
Phone:
412-641-8283
Email:
johnsonme15@upmc.edu
Contact backup:
Last name:
Wendie Berg, MD, PhD
Facility:
Name:
UPMC West Mifflin Outpatient Center
Address:
City:
West Mifflin
Zip:
15236
Country:
United States
Status:
Recruiting
Contact:
Last name:
McKenna Rigling, MS
Phone:
412-941-8278
Email:
riglingmm@upmc.edu
Contact backup:
Last name:
Maegan Johnson, RN
Phone:
412-641-8283
Email:
johnsonme15@upmc.edu
Contact backup:
Last name:
Wendie Berg, MD, PhD
Start date:
November 8, 2023
Completion date:
April 2031
Lead sponsor:
Agency:
Wendie Berg
Agency class:
Other
Collaborator:
Agency:
Breast Cancer Research Foundation
Agency class:
Other
Source:
University of Pittsburgh
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06105749
