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

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Alendronate; Copper

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)