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

Use of 64Cu-DOTA-Alendronate PET Imaging for Localization and Characterization of Breast Calcifications

This early phase I pilot trial studies how well 64Cu-DOTA-alendronate positron emission tomography (PET) imaging work in localizing and characterizing breast calcifications (small calcium deposits) in participants before undergoing mastectomy. Diagnostic procedures, such 64Cu-DOTA-alendronate PET, may detect calcification and help doctors predict cancer associated calcification within breast tissue.

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)