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

Tracking Information

First Received Date ^ICMJE

December 26, 2007

Last Updated Date

January 11, 2013

Start Date ^ICMJE

April 2007

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00584753 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Molecular Imaging of Breast Cancer With Breast PET/CT

Official Title ^ICMJE

Molecular Imaging of Breast Cancer With Breast PET/CT

Brief Summary

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.

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 ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Radiation: Positron emission tomography and computed tomography

Positron emission tomography and computed tomography

Other Name: Breast imaging

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

July 2011

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00584753

Other Study ID Numbers ^ICMJE

200715040

Has Data Monitoring Committee

Responsible Party

Ramsey Badawi, Ph.D, University of California, Davis

Study Sponsor ^ICMJE

University of California, Davis

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ramsey Badawi, PhD

University of California, Davis

Information Provided By

University of California, Davis

Verification Date

January 2013

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

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