Molecular Imaging of Breast Cancer With Breast PET/CT

Breast Cancer Clinical Trial

Official title:

Molecular Imaging of Breast Cancer With Breast PET/CT

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00584753
• Other study ID #: 200715040
• Status: Terminated
• Phase: Phase 1
• First received: December 26, 2007
• Last updated: January 11, 2013
• Start date: April 2007
• Est. completion date: July 2011

Study information

• Verified date: January 2013
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Positron emission tomography and computed tomography
Positron emission tomography and computed tomography
• Positron emission tomography and computed tomography
Positron emission tomography and computed tomography
• Positron emission tomography and computed tomography
Positron emission tomography and computed tomography

Locations

Country	Name	City	State
United States	UC David Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes