Molecular Imaging of Breast Cancer With Breast PET/CT

NCT00584753 | Terminated Phase 1

• 1 other identifier: 200715040
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

1

OTHER

Normal volunteers

Radiation: Positron emission tomography and computed tomography

2

ACTIVE COMPARATOR

Breast PET/CT scan

Radiation: Positron emission tomography and computed tomography

3

ACTIVE COMPARATOR

Whole body and breast PET/CT

Radiation: Positron emission tomography and computed tomography

Interventions

Positron emission tomography and computed tomography RADIATION

Positron emission tomography and computed tomography

Also known as: Breast imaging

3

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC David Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Ramsey Badawi, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 2, 2008
• Study Start: April 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 14, 2013

Record last verified: 2013-01

Locations

US (1)