Comparison of PEM Uptake Value (PUV) and Standardized Uptake Value (SUV) in Patients With Malignancies of the Breast

The goal of this clinical research study is to learn if using the PEMFlex Solo II, a high-resolution camera for positron emission tomography (PET) scan imaging, on an area of the body that has, or is suspected to have cancer will give researchers the same or better information about the disease compared to the images taken with a routine PET/computed tomography (CT).

Researchers will compare the images taken using the PEMFlex Solo II to the images taken during your scheduled routine PET/CT scan, as well as any additional routine CT scan(s), magnetic resonance imaging (MRI) scan(s), and/or ultrasound image(s) you may have had within the last 30 days or may have in the next 30 days.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

If you agree to take part in this study, right after your already scheduled routine PET/CT scan is complete, a study staff member will take you to a separate imaging room located in the same clinic area where your routine PET/CT scan was just performed.

You will then sit in a chair as a study staff member positions the PEMFlex Solo II on either side of your breast that has, or is suspected to have cancer. To take images using the PEMFlex Solo II, the breast is placed between two flat panels on the scanning machine and compressed (flattened). The position of the breast for this procedure is similar to getting a mammogram, but the PEMFlex Solo II uses about 50% less force to compress the breast(s). The compression will be repeated on the other breast if you are having scans of both breasts performed.

It will take about 20 minutes to set up the PEMFlex Solo II and take the PET scan images.

Length of Study:

After the PET scan images have been taken using the PEMFlex Solo II, your participation in this study will be over.

This is an investigational study. The PEMFlex Solo II is commercially available for PET scan imaging of the breast.

Up to 24 patients will take part in this study. All will be enrolled at M. D. Anderson.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

A signed informed consent.
Known or suspected malignancy involving the breast as determined by biopsy, physical examination or noninvasive imaging studies including plain films, CT, MR, ultrasound or nuclear medicine imaging.
Scheduled for routine clinical imaging at the ACB PET/CT facility.
Participant must be at least 18 years of age.

Exclusion criteria

Uncontrolled blood glucose levels (>200 mg/dl).
Patient is unable to comprehend the requirements of the study.
Patient is unable to undergo scanning of the known or suspected lesion with the high-resolution PEM (PET) scanner (due to body habitus, inability to comply with positioning requirements, etc.).

Treatment and study plan

Primary outcomes

Correlation between PUV and SUV of breast malignancies in patients undergoing [18F]-FDG-PET/CT scanning

Time frame: 20 minutes for imaging using PEMFlex Solo II

Formal quantitative assessment of the correlation between PUVmax values and maximum standardized uptake value (SUVmax) values performed by testing whether the Pearson correlation between these values exceeds 0.7.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

Pilot Study to Compare the PEM Uptake Value (PUV) and Standardized Uptake Value (SUV) in Patients With Malignancies of the Breast

Important dates

Study start: 2009
Primary completion: 2015
Study completion: 2015
First posted: Dec 14, 2009
Registry last updated: Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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