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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01008930
First received: November 5, 2009
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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 Intervention
Solid Tumors
Cancer
Procedure: HR PEM Scan

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Feasibility Study for Imaging of Peripheral Tumors With a High-Resolution PET Imaging System

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Study considered a success if 70% of lesions identified using standard images are also identifiable in the PEM image.


Enrollment: 19
Study Start Date: December 2009
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01008930

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77070
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Eric Rohren, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01008930     History of Changes
Other Study ID Numbers: 2009-0478, NCI-2011-02894
Study First Received: November 5, 2009
Last Updated: August 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Peripheral Tumors
Arm
Leg
Head
Neck
HR PET Imaging System
High-Resolution PET
PET/CT
PEMFlex Solo II
positron emission tomography/computed tomography (PET/CT)

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014