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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 : April 17, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

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
Breast Carcinoma Calcification Procedure: Computed Tomography Drug: Copper Cu-64-DOTA-alendronate Other: Pharmacokinetic Study Procedure: Positron Emission Tomography Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
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
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : December 7, 2020
Estimated Study Completion Date : December 7, 2020

Resource links provided by the National Library of Medicine


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 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




Primary Outcome Measures :
  1. 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.


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


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03542695


Locations
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United States, California
City of Hope Medical Center Not yet recruiting
Duarte, California, United States, 91010
Contact: Veronica C. Jones, MD    626-471-7100    vjones@coh.org   
Principal Investigator: Veronica C. Jones, MD         
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Veronica Jones, MD City of Hope Medical Center

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Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT03542695     History of Changes
Other Study ID Numbers: 18112
NCI-2018-00890 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
18112 ( Other Identifier: City of Hope Medical Center )
First Posted: May 31, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

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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:
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Breast Neoplasms
Calcinosis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs