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

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ClinicalTrials.gov Identifier: NCT03542695
Recruitment Status : Not yet recruiting
First Posted : May 31, 2018
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Tracking Information
First Submitted Date  ICMJE May 18, 2018
First Posted Date  ICMJE May 31, 2018
Last Update Posted Date August 7, 2019
Estimated Study Start Date  ICMJE October 2019
Estimated Primary Completion Date December 7, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03542695 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2018)
Uptake of 64Cu-DOTA-alendronate on positron emission tomography (PET) scan compared to histology after mastectomy [ Time Frame: Up to 7 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 64 Cu-DOTA-alendronate PET Imaging in Localizing and Characterizing Breast Calcifications in Participants Before Undergoing Mastectomy
Official Title  ICMJE Use of 64Cu-DOTA-Alendronate PET Imaging for Localization and Characterization of Breast Calcifications
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Breast Carcinoma
  • Calcification
Intervention  ICMJE
  • 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 Name: 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
Study Arms  ICMJE 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.
Interventions:
  • Procedure: Computed Tomography
  • Drug: Copper Cu-64-DOTA-alendronate
  • Other: Pharmacokinetic Study
  • Procedure: Positron Emission Tomography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 18, 2018)
6
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 7, 2020
Estimated Primary Completion Date December 7, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03542695
Other Study ID Numbers  ICMJE 18112
NCI-2018-00890 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
18112 ( Other Identifier: City of Hope Medical Center )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party City of Hope Medical Center
Study Sponsor  ICMJE City of Hope Medical Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Veronica Jones, MD City of Hope Medical Center
PRS Account City of Hope Medical Center
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP