Use of 64Cu-DOTA-Alendronate PET Imaging for Localization and Characterization of Breast Calcifications
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Maximum standardized uptake value (SUVmax) of 64Cu-DOTA-alendronate in evaluating tumor size and calcifications
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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.
Intervention: Computed Tomography (Procedure)
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.
Intervention: Copper Cu-64-DOTA-alendronate (Drug)
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.
Intervention: Pharmacokinetic Study (Other)
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.
Intervention: Positron Emission Tomography (Procedure)
Outcomes
Primary Outcomes
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 Outcomes
- Uptake of 64Cu-DOTA-alendronate on positron emission tomography (PET) scan compared to histology after mastectomy(Up to 7 days)