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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of 64Cu-DOTA-Alendronate PET Imaging for Localization and Characterization of Breast Calcifications

Conditions
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Breast Carcinoma, Calcification

Intervention / Treatment
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* Procedure: Computed Tomography
* Drug: Copper Cu-64-DOTA-alendronate
* Other: Pharmacokinetic Study
* Procedure: Positron Emission Tomography


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (64Cu-DOTA-alendronate, PET/CT scan)<br>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. | Procedure: Computed Tomography<br>* Undergo PET/CT<br>* Other names: tomography;Drug: Copper Cu-64-DOTA-alendronate<br>* Given IV<br>* Other names: 64Cu-DOTA-alendronate; [64Cu]-DOTA-alendronate;Other: Pharmacokinetic Study<br>* Correlative studies<br>* Other names: PK Study;Procedure: Positron Emission Tomography<br>* Undergo PET/CT<br>* Other names: proton magnetic resonance spectroscopic imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum standardized uptake value (SUVmax) of 64Cu-DOTA-alendronate in evaluating tumor size and calcifications | Tumor size sensitivity and the ability to detect calcifications will be compared to the extent of calcifications seen on mammogram. | Up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of 64Cu-DOTA-alendronate on positron emission tomography (PET) scan compared to histology after mastectomy |  | Up to 7 days |