Comparison of Breast Cancer Screening With CESM to DBT in Women With Dense Breasts

Inclusion Criteria:

• 1. Women must have mammographically dense breasts, ACR BI-RADS® lexicon categories cor d (heterogeneous or extreme fibroglandular tissue) on their most recent priorscreening.
• 2. Women agree to not undergo whole breast screening ultrasound for the duration ofthe trial until the year 2 standard of care imaging.
• 3. Women must not have symptoms or signs of benign or malignant breast disease (e.g., bloody, or clear nipple discharge, breast lump, focal breast pain).
• 4. Women must be able to undergo intravenous (IV) administration of iodinatedcontrast (e.g., no contraindication to intravenous contrast administration forOmnipaque [iohexol], and no known allergy-like reaction to iodine or moderate orsevere allergic reactions to one or more allergens as defined by the AmericanCollege of Radiology [ACR]:https://www.acr.org/-/media/ACR/files/clinical-resources/contrast_media.pdf).
• 5. Women must not be pregnant or breast-feeding. All females of childbearingpotential who are uncertain if they could be pregnant or may be pregnant or as perlocal site standard of practice in women undergoing DBT and CESM must have anegative blood test or urine pregnancy test prior to Omnipaque (iohexol)administration. A female of childbearing potential is any woman, regardless ofsexual orientation, sexual identity or whether they have undergone tubal ligation,who meets the following criteria: 1) has not undergone a hysterectomy or bilateraloophorectomy; or 2) has not been naturally postmenopausal for at least 24consecutive months (i.e., has had menses at any time in the preceding 24 consecutivemonths).
• 6. Women of childbearing potential must be strongly advised to use an accepted andeffective method of contraception or to abstain from sexual intercourse for thefollowing year until the Year 1 DBT and CESM studies are performed.

Exclusion Criteria:

• 1. Women currently undergoing treatment for breast cancer, or planning surgery for ahigh-risk lesion (ADH, ALH, LCIS, papilloma, radial scar).
• 2. Women who have had the following are not eligible:

1. a mammogram less than 11 months prior to study entry.

2. screening breast ultrasound within 11 months prior to study entry.

3. breast MRI less than 36 months prior to study entry.

4. contrast-enhanced spectral mammography less than 36 months prior to studyentry.

5. molecular breast imaging (MBI) less than 36 months prior to study entry.

6. breast prosthetic implants (silicone or saline).

7. suspected of being at high-risk for breast cancer, as defined by the ACS breastMR screening recommendations (lifetime risk of ≥20%-25%) unless they are unableto undergo an MRI. (Reference Appendix I)

8. a history of sickle cell disease.

• 3. Women with known or suspected renal impairment. Requirements for glomerularfiltration rate (GFR) determination prior to IV iodinated contrast administrationare determined by local site standard practice. Criteria that should be consideredinclude, but are not limited to, the following:

• Age >60 years old

• History of renal disease, including dialysis, kidney transplant, single kidney,renal cancer, and renal surgery

• History of hypertension requiring medical therapy

• History of diabetes mellitus

• Use of metformin or metformin-containing drug combinations

• 4. Women who are pregnant, breast feeding, or planning to become pregnant fromscreening until 30 days after the last administration of Omnipaque (iohexol).
• 5. Large breasted women that require multiple images per standard view of the breast (Tiling) as determined by their most recent mammogram.