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

Early Phase 1

Completed

• Conditions: Calcification; Breast Carcinoma
• Interventions: Procedure: Computed Tomography; Drug: Copper Cu-64-DOTA-alendronate; Other: Pharmacokinetic Study; Procedure: Positron Emission Tomography

• Registration Number: NCT03542695
• Lead Sponsor: City of Hope Medical Center

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.

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 Timeline

• Study First Submitted: 2018-05-18
• Study First Submitted QC: 2018-05-18
• Study First Posted: 2018-05-31
• Study Start: 2021-11-03
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (64Cu-DOTA-alendronate, PET/CT scan)	Copper Cu-64-DOTA-alendronate	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.
Diagnostic (64Cu-DOTA-alendronate, PET/CT scan)	Computed Tomography	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.
Diagnostic (64Cu-DOTA-alendronate, PET/CT scan)	Positron Emission Tomography	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.
Diagnostic (64Cu-DOTA-alendronate, PET/CT scan)	Pharmacokinetic Study	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.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States