Feasibility Study for Imaging of Peripheral Tumors With a High-Resolution PET Imaging System
18 Years
N/A
Both
Solid Tumors, Cancer
Trial Information
Feasibility Study for Imaging of Peripheral Tumors With a High-Resolution PET Imaging System
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.
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.).
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
Outcome Measure:
Number of peripheral tumor lesions identified in standard PET/CT imaging also identifiable in PEM images.
Outcome Time Frame:
20 minutes for imaging using PEMFlex Solo II
Safety Issue:
No
Principal Investigator
Eric Rohren, MD
Investigator Role:
Study Chair
Investigator Affiliation:
UT MD Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2009-0478
NCT ID:
NCT01008930
Start Date:
December 2009
Completion Date:
Related Keywords:
- Solid Tumors
- Cancer
- 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)
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
