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

City of Hope

Status and phase: Completed; Early Phase 1

Conditions: Calcification; Breast Carcinoma

Treatments: Other: Pharmacokinetic Study; Drug: Copper Cu-64-DOTA-alendronate; Procedure: Computed Tomography; Procedure: Positron Emission Tomography

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03542695

NCI-2018-00890 (Registry Identifier)

18112 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Diagnostic (64Cu-DOTA-alendronate, PET/CT scan)

Experimental group

Description:

Participants receive 64Cu-DOTA-alendronate 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.

Treatment:

Procedure: Positron Emission Tomography

Procedure: Computed Tomography

Drug: Copper Cu-64-DOTA-alendronate

Other: Pharmacokinetic Study