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

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03542695

Enrollment

Registered

2018-05-31

Start date

2021-11-03

Completion date

2024-05-31

Last updated

2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Carcinoma, Calcification

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.

Interventions

PROCEDUREComputed Tomography

Undergo PET/CT

DRUGCopper Cu-64-DOTA-alendronate

Given IV

OTHERPharmacokinetic Study

Correlative studies

PROCEDUREPositron Emission Tomography

Undergo PET/CT

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026