Active, not recruiting • Phase O • Stage 0, I, II, III, IV • Post-Menopausal • Interventional

The following is imported from ClinicalTrials.gov:

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

Brief Summary

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.

Description

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.

Study Design

Eligibility Criteria

Arms and Intervention

• Computed Tomography

• Copper Cu-64-DOTA-alendronate

• Pharmacokinetic Study

• Positron Emission Tomography

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)