Molecular Imaging of Breast Cancer With Breast PET/CT

Phase 1

Terminated

• Conditions: Breast Cancer
• Interventions: Radiation: Positron emission tomography and computed tomography

• Registration Number: NCT00584753
• Lead Sponsor: University of California, Davis

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 Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2007-12-26
• Study First Posted: 2008-01-02
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-11
• Last Update Posted: 2013-01-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Positron emission tomography and computed tomography	Normal volunteers
2	Positron emission tomography and computed tomography	Breast PET/CT scan
3	Positron emission tomography and computed tomography	Whole body and breast PET/CT

Primary Outcome Measures

Name	Time	Method
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.	5 years

Trial Locations

Locations (1)

UC David Medical Center; 🇺🇸 Sacramento, California, United States