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Clinical Trial 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT03542695
Study type Interventional
Source City of Hope Medical Center
Contact
Status Active, not recruiting
Phase Early Phase 1
Start date November 3, 2021
Completion date February 20, 2025

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