64 Cu-DOTA-alendronate PET Imaging in Localizing and Characterizing Breast Calcifications in Participants Before Undergoing Mastectomy
June 21, 2024 updated by: City of Hope Medical Center
Use of 64Cu-DOTA-Alendronate PET Imaging for Localization and Characterization of Breast Calcifications
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
1
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Duarte, California, United States, 91010
- City of Hope Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
Correlative studies
Other Names:
Undergo PET/CT
Other Names:
Undergo PET/CT
Other Names:
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Up to 7 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Uptake of 64Cu-DOTA-alendronate on positron emission tomography (PET) scan compared to histology after mastectomy
Time Frame: Up to 7 days
|
Up to 7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Veronica Jones, MD, City of Hope Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 3, 2021
Primary Completion (Actual)
May 31, 2024
Study Completion (Actual)
May 31, 2024
Study Registration Dates
First Submitted
May 18, 2018
First Submitted That Met QC Criteria
May 18, 2018
First Posted (Actual)
May 31, 2018
Study Record Updates
Last Update Posted (Actual)
June 24, 2024
Last Update Submitted That Met QC Criteria
June 21, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18112 (City of Hope Medical Center)
- NCI-2018-00890 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.