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

Sponsor
City of Hope Medical Center (Other)
Overall Status
Suspended
CT.gov ID
NCT03542695
Collaborator
National Cancer Institute (NCI) (NIH)
6
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1
24.9
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Computed Tomography
  • Drug: Copper Cu-64-DOTA-alendronate
  • Other: Pharmacokinetic Study
  • Procedure: Positron Emission Tomography
Early Phase 1

Detailed Description

PRIMARY OBJECTIVES:
  1. To evaluate the uptake (maximum standardized uptake value [SUVmax]) of 64Cu-DOTA-alendronate in female patients with biopsy-proven malignant breast calcifications.
SECONDARY OBJECTIVES:
  1. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Use of 64Cu-DOTA-Alendronate PET Imaging for Localization and Characterization of Breast Calcifications
Actual Study Start Date :
Nov 3, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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.

Procedure: Computed Tomography
Undergo PET/CT
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • computerized tomography
  • CT
  • CT SCAN
  • tomography
  • Drug: Copper Cu-64-DOTA-alendronate
    Given IV
    Other Names:
  • 64Cu-DOTA-alendronate; [64Cu]-DOTA-alendronate
  • Other: Pharmacokinetic Study
    Correlative studies
    Other Names:
  • PHARMACOKINETIC
  • PK Study
  • Procedure: Positron Emission Tomography
    Undergo PET/CT
    Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
  • Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. Uptake of 64Cu-DOTA-alendronate on positron emission tomography (PET) scan compared to histology after mastectomy [Up to 7 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Medical Center Duarte California United States 91010

    Sponsors and Collaborators

    • City of Hope Medical Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Veronica Jones, MD, City of Hope Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    City of Hope Medical Center
    ClinicalTrials.gov Identifier:
    NCT03542695
    Other Study ID Numbers:
    • 18112
    • NCI-2018-00890
    • 18112
    First Posted:
    May 31, 2018
    Last Update Posted:
    Jun 9, 2022
    Last Verified:
    Jun 1, 2022
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 9, 2022