Clinical trial NCT03542695: 64 Cu-DOTA-alendronate PET Imaging in Localizing and Characterizing Breast Calcifications in Participants Before Undergoing Mastectomy
Official title: Use of 64Cu-DOTA-Alendronate PET Imaging for Localization and Characterization of Breast Calcifications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Breast Carcinoma
Calcification
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-05-31
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Maximum standardized uptake value (SUVmax) of 64Cu-DOTA-alendronate in evaluating tumor size and calcifications
timeFrame: Up to 7 days
Secondary outcomes:
measure: Uptake of 64Cu-DOTA-alendronate on positron emission tomography (PET) scan compared to histology after mastectomy
timeFrame: Up to 7 days
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Veronica Jones, MD
role: PRINCIPAL_INVESTIGATOR
References: