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

Primary Purpose

Breast Carcinoma, Calcification

Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Computed Tomography
Copper Cu-64-DOTA-alendronate
Pharmacokinetic Study
Positron Emission Tomography
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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)

Sites / Locations

  • City of Hope Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (64Cu-DOTA-alendronate, PET/CT scan)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Uptake of 64Cu-DOTA-alendronate on positron emission tomography (PET) scan compared to histology after mastectomy

Full Information

First Posted
May 18, 2018
Last Updated
June 19, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03542695
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 3, 2021 (Actual)
Primary Completion Date
February 20, 2025 (Anticipated)
Study Completion Date
February 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma, Calcification

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (64Cu-DOTA-alendronate, PET/CT scan)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography
Intervention Description
Undergo PET/CT
Intervention Type
Drug
Intervention Name(s)
Copper Cu-64-DOTA-alendronate
Other Intervention Name(s)
64Cu-DOTA-alendronate; [64Cu]-DOTA-alendronate
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
Pharmacokinetic Study
Other Intervention Name(s)
PHARMACOKINETIC, PK Study
Intervention Description
Correlative studies
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Intervention Description
Undergo PET/CT
Primary Outcome Measure Information:
Title
Maximum standardized uptake value (SUVmax) of 64Cu-DOTA-alendronate in evaluating tumor size and calcifications
Description
Tumor size sensitivity and the ability to detect calcifications will be compared to the extent of calcifications seen on mammogram.
Time Frame
Up to 7 days
Secondary Outcome Measure Information:
Title
Uptake of 64Cu-DOTA-alendronate on positron emission tomography (PET) scan compared to histology after mastectomy
Time Frame
Up to 7 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronica Jones, MD
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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