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

M.D. Anderson Cancer Center logo

M.D. Anderson Cancer Center

Status

Completed

Conditions

Cancer
Solid Tumors

Treatments

Procedure: HR PEM Scan

Study type

Interventional

Funder types

Other

Identifiers

NCT01008930
NCI-2011-02894 (Registry Identifier)
2009-0478

Details and patient eligibility

About

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.

Full 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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.).

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

19 participants in 1 patient group

PEM Scan
Experimental group
Description:
HR PEM images (High Resolution PEMFlex Solo II scan images)
Treatment:
Procedure: HR PEM Scan

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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