64 Cu-DOTA-alendronate PET Imaging in Localizing and Characterizing Breast Calcifications in Participants Before Undergoing Mastectomy
NCT ID: NCT03542695
Last Updated: 2024-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
1 participants
INTERVENTIONAL
2021-11-03
2024-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
Computed Tomography
Undergo PET/CT
Copper Cu-64-DOTA-alendronate
Given IV
Pharmacokinetic Study
Correlative studies
Positron Emission Tomography
Undergo PET/CT
Interventions
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Computed Tomography
Undergo PET/CT
Copper Cu-64-DOTA-alendronate
Given IV
Pharmacokinetic Study
Correlative studies
Positron Emission Tomography
Undergo PET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Veronica Jones, MD
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Other Identifiers
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NCI-2018-00890
Identifier Type: REGISTRY
Identifier Source: secondary_id
18112
Identifier Type: OTHER
Identifier Source: secondary_id
18112
Identifier Type: -
Identifier Source: org_study_id
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