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Molecular Imaging of Breast Cancer With Breast PET/CT

This study has been terminated.
(Low enrollment)
Sponsor:
Information provided by (Responsible Party):
Ramsey Badawi, Ph.D, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00584753
First received: December 26, 2007
Last updated: January 11, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Radiation: Positron emission tomography and computed tomography
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Molecular Imaging of Breast Cancer With Breast PET/CT

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 4
Study Start Date: April 2007
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Normal volunteers
 Radiation: Positron emission tomography and computed tomography
Positron emission tomography and computed tomography
Other Name: Breast imaging
Active Comparator: 2
Breast PET/CT scan
 Radiation: Positron emission tomography and computed tomography
Positron emission tomography and computed tomography
Other Name: 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 Name: Breast imaging

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584753

Locations
United States, California
UC David Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Ramsey Badawi, PhD University of California, Davis
  More Information

No publications provided

Responsible Party: Ramsey Badawi, Ph.D, Associate Professor, University of California, Davis
ClinicalTrials.gov Identifier: NCT00584753     History of Changes
Other Study ID Numbers: 200715040
Study First Received: December 26, 2007
Last Updated: January 11, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of California, Davis:
Breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 17, 2013