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Positron Emission Tomography Imaging Using Copper Cu 64 TP3805 in Patients With Breast Cancer

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ClinicalTrials.gov Identifier: NCT02810873
Recruitment Status : Terminated (Study terminated by PI)
First Posted : June 23, 2016
Results First Posted : January 9, 2018
Last Update Posted : January 9, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Brief Summary:
This clinical trial studies positron emission tomography imaging in using copper Cu 64 TP3805in patients with breast cancer. Diagnostic procedures, such as positron emission tomography (PET) and positron emission mammography (PEM) scan, using Cu-64-TP3805 may help doctors find and diagnose breast cancer.

Condition or disease Intervention/treatment Phase
Breast Carcinoma Device: Positron Emission Mammography Device: Positron Emission Tomography Radiation: Fludeoxyglucose F-18 Drug: Copper Cu 64 TP3805 Not Applicable

Detailed Description:

OBJECTIVES:

I. The study's primary goal is to assess the ability of Cu-64-TP3805 (copper Cu 64 TP3805) to detect primary breast lesions as determined by the F-18-FDG (fludeoxyglucose F 18) scan.

II. The study's second goal is to determine the ability of Cu-64-TP3805 to detect primary breast lesions as determined by histology (sensitivity).

III. The study's third goal is to determine the ability of Cu-64-TP3805 to detect metastatic lesions as identified by the F-18-FDG whole-body scan.

OUTLINE: This is a dose-finding 2-stage study.

STAGE I: Patients with a positive biopsy and abnormal (positive) fludeoxyglucose F18-labeled PET whole-body scan undergo a whole-body copper Cu 64 TP3805-labeled PET scan.

STAGE II: Patients with a positive biopsy, but no fludeoxyglucose F18 scan undergo a breast fludeoxyglucose F18-labeled PEM scan followed by a breast copper Cu 64 TP3805-labeled PEM scan.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PET Imaging of Breast Cancer Using Oncogene Expression
Study Start Date : September 2008
Actual Primary Completion Date : May 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: F-18-FDG Whole body Scan
STAGE I: Patients with a positive biopsy and abnormal (positive) fludeoxyglucose F18-labeled PET whole-body scan undergo a whole-body copper Cu 64 TP3805-labeled PET scan.
Device: Positron Emission Mammography
Undergo PEM Positron Emission Mammography scan

Radiation: Fludeoxyglucose F-18
Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan
Other Names:
  • 2-Deoxy-2-(18F)Fluoro-D-Glucose
  • 2-F18-Fluoro-2-deoxy-D-glucose
  • 2-F18-Fluoro-2-deoxyglucose
  • 105851-17-0
  • 18FDG
  • 723398
  • FDG
  • Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
  • Fluorodeoxyglucose F18

Drug: Copper Cu 64 TP3805
Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan
Other Name: Cu-64-TP3805

Experimental: No F-18-FDG Scan
STAGE II: Patients with a positive biopsy, but no fludeoxyglucose F18 scan undergo a breast fludeoxyglucose F18-labeled PEM Positron Emission Mammography scan followed by a breast copper Cu 64 TP3805-labeled PEM scan.
Device: Positron Emission Tomography
Undergo PET Positron Emission Tomography scan
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • proton magnetic resonance spectroscopic imaging

Radiation: Fludeoxyglucose F-18
Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan
Other Names:
  • 2-Deoxy-2-(18F)Fluoro-D-Glucose
  • 2-F18-Fluoro-2-deoxy-D-glucose
  • 2-F18-Fluoro-2-deoxyglucose
  • 105851-17-0
  • 18FDG
  • 723398
  • FDG
  • Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
  • Fluorodeoxyglucose F18

Drug: Copper Cu 64 TP3805
Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan
Other Name: Cu-64-TP3805




Primary Outcome Measures :
  1. Number of F-18-FDG Positive Lesions That Are Detected by the Copper Cu 64 TP3805 Analog [ Time Frame: 4 hours after Cu 64 TP3805 administered ]
    Cu-64 results will be compared with those of F-18-FDG for: The unit of analysis will be the lesion (with potentially multiple lesions available per patient).


Secondary Outcome Measures :
  1. Ability of Copper Cu 64 TP3805 to Detect Primary Breast Lesions as Determined by Histology (Sensitivity) [ Time Frame: 4 hours after Cu 64 TP3805 administered ]
    Optimal imaging time is the one (of the three) which will have least background activity in the surrounding tissue and image the maximum number of lesions with clarity. 95% confidence intervals will be used. To account for the multiplicity of lesions per patient, the GEE approach will be used, with the robust variance. Any adverse events will be summarized descriptively.



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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:

  • Female
  • Breast cancer shown with abnormal mammogram and histology verification (stage-1 patients will also need to have a positive F-18-FDG whole-body scan)
  • Tumor mass of 1 cm or larger, as determined by mammography, ultrasound, or magnetic resonance imaging (MRI)
  • Signed informed consent form approved by the institutional review board (IRB)

Exclusion Criteria:

  • Pregnant or lactating female
  • Patient with asthma

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): NCT02810873


Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Madhukar Thakur, PhD Thomas Jefferson University

Additional Information:
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Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02810873     History of Changes
Other Study ID Numbers: 08F.327
First Posted: June 23, 2016    Key Record Dates
Results First Posted: January 9, 2018
Last Update Posted: January 9, 2018
Last Verified: December 2017

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Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Copper
Fluorodeoxyglucose F18
Deoxyglucose
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antiviral Agents
Anti-Infective Agents