NCT03542695

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Breast Carcinoma
• Calcification

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo PET/CT
DRUG	Copper Cu-64-DOTA-alendronate	Given IV
OTHER	Pharmacokinetic Study	Correlative studies
PROCEDURE	Positron Emission Tomography	Undergo PET/CT

Timeline

• Start date: 2021-11-03
• Primary completion: 2024-05-31
• Completion: 2024-05-31
• First posted: 2018-05-31
• Last updated: 2024-06-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study