Molecular Imaging of Breast Cancer With Breast PET/CT

January 11, 2013 updated by: Ramsey Badawi, Ph.D, University of California, Davis
This study is a feasibility study to determine if a combined breast PET/CT scanner can image malignant functional activity while determining anatomical structure in the same clinical setting for patients with breast cancer. End-points of this study are whether women will accept the imaging position and timing, and whether functional properties of breast cancer can be imaged with this device. The secondary purpose of this study is to explore protocol parameters with a view to optimizing imaging performance whilst minimizing patient discomfort. Imaging results will be compared to histological samples to determine ground truth.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

PET is literally a molecular imaging modality. In monitoring the patient's response to a specific chemotherapeutic regime, baseline and subsequent PET/CT scans can be used to quantitatively determine the therapeutic effect of the regime, using the standard uptake value (SUV), a common metric in PET imaging. The breast PET/CT system will facilitate molecular imaging of breast cancer using a number of radiolabeled molecules, available both commercially (18-FDG) and from the research environment.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • UC David Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

- Normal Adult Volunteers

  • Female, at least 18 years of age
  • Ability to lie motionless for up to 20 minutes

Patient Volunteers

  • Female, at least 18 years of age
  • Diagnostic findings from prior mammography highly suggestive of invasive breast carcinoma (BI-RADS category 5)
  • Not pregnant or breast-feeding
  • Ability to lie motionless for up to 20 minutes

Exclusion Criteria:

  • Normal Adult Volunteers

    • Inability to understand the risks and benefits of the study

Patient Volunteers

  • Recent breast biopsy
  • Diagnostic findings from prior mammography highly suggestive of noninvasive ductal or lobular carcinoma
  • Uncontrolled diabetes
  • Diabetic and blood sugar level > 200 mg/dL
  • Positive urine pregnancy test or currently breast-feeding
  • Inability to understand the risks and benefits of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Normal volunteers
Radiation: Positron emission tomography and computed tomography
Positron emission tomography and computed tomography
Other Names:
  • Breast imaging
Active Comparator: 2
Breast PET/CT scan
Radiation: Positron emission tomography and computed tomography
Positron emission tomography and computed tomography
Other Names:
  • Breast imaging
Active Comparator: 3
Whole body and breast PET/CT
Radiation: Positron emission tomography and computed tomography
Positron emission tomography and computed tomography
Other Names:
  • Breast imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
End-points of this study are whether women will accept the imaging position and timing, and whether functional properties of breast cancer can be imaged with this device.
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

  • Principal Investigator: Ramsey Badawi, PhD, University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

December 26, 2007

First Posted (Estimate)

January 2, 2008

Study Record Updates

Last Update Posted (Estimate)

January 14, 2013

Last Update Submitted That Met QC Criteria

January 11, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200715040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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