64 Cu-DOTA-alendronate PET Imaging in Localizing and Characterizing Breast Calcifications in Participants Before Undergoing Mastectomy
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Early Phase 1 |
Detailed Description
PRIMARY OBJECTIVES:
- To evaluate the uptake (maximum standardized uptake value [SUVmax]) of 64Cu-DOTA-alendronate in female patients with biopsy-proven malignant breast calcifications.
SECONDARY OBJECTIVES:
- 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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
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. |
Procedure: Computed Tomography
Undergo PET/CT
Other Names:
Drug: Copper Cu-64-DOTA-alendronate
Given IV
Other Names:
Other: Pharmacokinetic Study
Correlative studies
Other Names:
Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Maximum standardized uptake value (SUVmax) of 64Cu-DOTA-alendronate in evaluating tumor size and calcifications [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 Outcome Measures
- Uptake of 64Cu-DOTA-alendronate on positron emission tomography (PET) scan compared to histology after mastectomy [Up to 7 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Evidence of calcifications on mammogram
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Biopsy confirmed malignancy associated calcifications in at least one breast
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Biopsy confirmed benign calcifications in at least one breast (same or contralateral breast)
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Planned total mastectomy for treatment
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Ability to provide informed consent
-
Negative serum pregnancy test
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No evidence of impaired hepatic or kidney function
Exclusion Criteria:
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Participants who do not have residual calcifications present on mammogram following biopsy
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Concurrent malignancy other than non-melanoma skin cancer
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Patients with known metastatic disease
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Patients who have received prior treatment for the current breast cancer
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Patients currently using oral bisphosphonate therapy
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Patients with injection of other radioactive material within 90 days
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Inability to provide informed consent
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Pregnant or lactating patients
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Patients with impaired kidney function (creatinine >= 1.3 mg/dL or < 0.6 mg/dL)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | City of Hope Medical Center | Duarte | California | United States | 91010 |
Sponsors and Collaborators
- City of Hope Medical Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Veronica Jones, MD, City of Hope Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18112
- NCI-2018-00890
- 18112