Breast Cancer Clinical Trial
64 Cu-DOTA-alendronate PET Imaging in Localizing and Characterizing Breast Calcifications in Participants Before Undergoing Mastectomy
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.
Full 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.
Eligibility Criteria
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)
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There is 1 Location for this study
Duarte California, 91010, United States
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