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

Early Phase 1CompletedNCT03542695

City of Hope Medical Center1 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Breast Carcinoma Calcification

Interventions

Computed TomographyPROCEDURE

Undergo PET/CT

Copper Cu-64-DOTA-alendronateDRUG

Given IV

Pharmacokinetic StudyOTHER

Correlative studies

Positron Emission Tomography

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

City of Hope Medical Center

Duarte, California, United States

Outcomes

Primary Outcomes

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.

Time frame: Up to 7 days

Secondary Outcomes

Uptake of 64Cu-DOTA-alendronate on positron emission tomography (PET) scan compared to histology after mastectomy

Time frame: Up to 7 days

Data from ClinicalTrials.gov

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