Molecular Imaging of Breast Cancer With Breast PET/CT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Normal volunteers

Group Type OTHER

Positron emission tomography and computed tomography

Intervention Type RADIATION

Positron emission tomography and computed tomography

2

Breast PET/CT scan

Group Type ACTIVE_COMPARATOR

Positron emission tomography and computed tomography

Intervention Type RADIATION

Positron emission tomography and computed tomography

3

Whole body and breast PET/CT

Group Type ACTIVE_COMPARATOR

Positron emission tomography and computed tomography

Intervention Type RADIATION

Positron emission tomography and computed tomography

Interventions

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Positron emission tomography and computed tomography

Intervention Type RADIATION

Positron emission tomography and computed tomography

Intervention Type RADIATION

Positron emission tomography and computed tomography

Intervention Type RADIATION

Other Intervention Names

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Breast imaging Breast imaging Breast imaging

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes