Molecular Imaging of Breast Cancer With Breast PET/CT - Full Text View

Sponsored by:	University of California, Davis
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00584753

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 I

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer CT Scans Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Parallel Assignment
Official Title:	Molecular Imaging of Breast Cancer With Breast PET/CT

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 ]

Estimated Enrollment:	20
Study Start Date:	April 2007
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	April 2012 (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
2: Active Comparator Breast PET/CT scan	Radiation: Positron emission tomography and computed tomography Positron emission tomography and computed tomography
3: Active Comparator Whole body and breast PET/CT	Radiation: Positron emission tomography and computed tomography Positron emission tomography and computed tomography

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

- Normal Adult Volunteers

Female, 35 to 80 years of age
Ability to lie motionless for up to 20 minutes

Patient Volunteers

Female, 35 to 80 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

Contacts

Contact: Ramsey Badawi, PhD

916-734-7940

ramsey.badawi@ucdmc.ucdavis.edu

Locations

United States, California
UC David Medical Center	Recruiting
Sacramento, California, United States, 95817
Contact: Ramsey Batawi, PhD 916-734-7940 ramsey.badawi@ucdmc.ucdavis.edu

Sponsors and Collaborators

University of California, Davis

Investigators

Principal Investigator:

Ramsey Badawi, PhD

University of California, Davis

More Information

Responsible Party:	University of California, Davis, Dept of Radiology ( Ramsey Badawi, PhD )
Study ID Numbers:	200715040
Study First Received:	December 26, 2007
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00584753
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Keywords provided by University of California, Davis:

Breast cancer

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009