64 Cu-DOTA-alendronate PET Imaging in Localizing and Characterizing Breast Calcifications in Participants Before Undergoing Mastectomy

PRIMARY OBJECTIVES:

I. To evaluate the uptake (maximum standardized uptake value [SUVmax]) of
64Cu-DOTA-alendronate in female patients with biopsy-proven malignant breast calcifications.

SECONDARY OBJECTIVES:

I. To compare uptake of 64Cu-DOTA-alendronate on PET -computed tomography (CT) with histology
after mastectomy.

OUTLINE: This is a dose-escalation study of 64Cu-DOTA-alendronate.

Participants receive 64Cu-DOTA-alendronate intravenously (IV) and undergo PET/CT imaging 60
minutes after injection. Participants with sufficient levels of residual radioactivity may
undergo repeat imaging on day 1 as determined by the study team.

After completion of study , participants are followed up for 7 days.

Inclusion Criteria:

- Evidence of calcifications on mammogram

- Biopsy confirmed malignancy associated calcifications in at least one breast

- Biopsy confirmed benign calcifications in at least one breast (same or contralateral
breast)

- Planned total mastectomy for treatment

- Ability to provide informed consent

- Negative serum pregnancy test

- No evidence of impaired hepatic or kidney function

Exclusion Criteria:

- Participants who do not have residual calcifications present on mammogram following
biopsy

- Concurrent malignancy other than non-melanoma skin cancer

- Patients with known metastatic disease

- Patients who have received prior treatment for the current breast cancer

- Patients currently using oral bisphosphonate therapy

- Patients with injection of other radioactive material within 90 days

- Inability to provide informed consent

- Pregnant or lactating patients

- Patients with impaired kidney function (creatinine >= 1.3 mg/dL or < 0.6 mg/dL)