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Feasibility Study for Imaging of Peripheral Tumors With a High-Resolution PET Imaging System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01008930
Recruitment Status : Completed
First Posted : November 6, 2009
Last Update Posted : August 20, 2014
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

The goal of this clinical research study is to learn if using the PEMFlex Solo II, a high-resolution camera for 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/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.

Condition or disease Intervention/treatment Phase
Solid Tumors Cancer Procedure: HR PEM Scan Not Applicable

Detailed Description:

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 the area being checked for cancer. 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 and designed for PET scan imaging of the breast. The use of the PEMFlex Solo II for imaging other parts of the body is investigational.

Up to 20 patients will take part in this study. All will be enrolled at M. D. Anderson.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Feasibility Study for Imaging of Peripheral Tumors With a High-Resolution PET Imaging System
Study Start Date : December 2009
Actual Primary Completion Date : August 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: PEM Scan
HR PEM images (High Resolution PEMFlex Solo II scan images)
Procedure: HR PEM Scan
PEMFlex Solo II, a high-resolution camera for PET scan imaging, on an area of body that has, or is suspected to have cancer following routine, standard, positron emission tomography/computed tomography (PET/CT) scan
Other Names:
  • HR PET/CT Scan
  • PET/CT Imaging
  • PET
  • CT
  • Computed Tomography

Primary Outcome Measures :
  1. Number of peripheral tumor lesions identified in standard PET/CT imaging also identifiable in PEM images. [ Time Frame: 20 minutes for imaging using PEMFlex Solo II ]
    Study considered a success if 70% of lesions identified using standard images are also identifiable in the PEM image.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. A signed informed consent.
  2. Known or suspected primary or metastatic lesion of the extremities, head or neck as determined by biopsy, physical examination or noninvasive imaging studies including plain films, CT, MR, ultrasound or nuclear medicine imaging.
  3. Scheduled for routine clinical imaging at the ACB PET/CT facility.
  4. Participant must be at least 18 years of age.

Exclusion Criteria:

  1. Uncontrolled blood glucose levels (>200 mg/dl).
  2. Patient is unable to comprehend the requirements of the study.
  3. 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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01008930

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77070
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Study Chair: Eric Rohren, MD UT MD Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01008930    
Other Study ID Numbers: 2009-0478
NCI-2011-02894 ( Registry Identifier: NCI CTRP )
First Posted: November 6, 2009    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014
Keywords provided by M.D. Anderson Cancer Center:
Peripheral Tumors
HR PET Imaging System
High-Resolution PET
PEMFlex Solo II
positron emission tomography/computed tomography (PET/CT)
Additional relevant MeSH terms:
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