Clinical Trial · NCT03542695

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

Overview

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.

Sponsor

City of Hope Medical Center

Phase

Early Phase 1

Contacts

Veronica Jones, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03542695

Drug / Compound

alendronate

Isotope(s):

Target(s):

Hydroxyapatite (bone mineral / calcifications)

Ligand Class: Small Molecules

Chelator: DOTA

Eligibility

Inclusion

No evidence of impaired hepatic or kidney function
Biopsy confirmed benign calcifications in at least one breast (same or contralateral breast)
Negative serum pregnancy test
Evidence of calcifications on mammogram
Biopsy confirmed malignancy associated calcifications in at least one breast
Planned total mastectomy for treatment

Exclusion

Patients currently using oral bisphosphonate therapy
Patients who have received prior treatment for the current breast cancer
Pregnant or lactating patients
Patients with impaired kidney function (creatinine \>= 1.3 mg/dL or \< 0.6 mg/dL)
Patients with injection of other radioactive material within 90 days
Participants who do not have residual calcifications present on mammogram following biopsy
Patients with known metastatic disease