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.

Full Title of Study: “Use of 64Cu-DOTA-Alendronate PET Imaging for Localization and Characterization of Breast Calcifications”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 1, 2023

Detailed 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.

Interventions

  • Procedure: Computed Tomography
    • Undergo PET/CT
  • Drug: Copper Cu-64-DOTA-alendronate
    • Given IV
  • Other: Pharmacokinetic Study
    • Correlative studies
  • Procedure: Positron Emission Tomography
    • Undergo PET/CT

Arms, Groups and Cohorts

  • Experimental: Diagnostic (64Cu-DOTA-alendronate, PET/CT scan)
    • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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)

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • City of Hope Medical Center
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Veronica Jones, MD, Principal Investigator, City of Hope Medical Center

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