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

December 26, 2007
January 11, 2013
April 2007
July 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00584753 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Molecular Imaging of Breast Cancer With Breast PET/CT
Molecular Imaging of Breast Cancer With Breast PET/CT

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Breast Cancer
Radiation: Positron emission tomography and computed tomography
Positron emission tomography and computed tomography
Other Name: Breast imaging
  • 1
    Normal volunteers
    Intervention: Radiation: Positron emission tomography and computed tomography
  • Active Comparator: 2
    Breast PET/CT scan
    Intervention: Radiation: Positron emission tomography and computed tomography
  • Active Comparator: 3
    Whole body and breast PET/CT
    Intervention: Radiation: Positron emission tomography and computed tomography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00584753
200715040
No
Ramsey Badawi, Ph.D, University of California, Davis
University of California, Davis
Not Provided
Principal Investigator: Ramsey Badawi, PhD University of California, Davis
University of California, Davis
January 2013

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