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

Breast Carcinoma Clinical Trial

Official title:

Use of 64Cu-DOTA-Alendronate PET Imaging for Localization and Characterization of Breast Calcifications

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03542695
• Other study ID #: 18112
• Secondary ID: NCI-2018-0089018
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: November 3, 2021
• Est. completion date: February 20, 2025

Study information

• Verified date: June 2023
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1
• Est. completion date: February 20, 2025
• Est. primary completion date: February 20, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Calcification
• Calcinosis

Intervention

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

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum standardized uptake value (SUVmax) of 64Cu-DOTA-alendronate in evaluating tumor size and calcifications	Tumor size sensitivity and the ability to detect calcifications will be compared to the extent of calcifications seen on mammogram.	Up to 7 days
Secondary	Uptake of 64Cu-DOTA-alendronate on positron emission tomography (PET) scan compared to histology after mastectomy		Up to 7 days