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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01008930
• Other study ID #: 2009-0478
• Secondary ID: NCI-2011-02894
• Status: Completed
• Phase: N/A
• First received: November 5, 2009
• Last updated: August 19, 2014
• Start date: December 2009

Study information

• Verified date: August 2014
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.).

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Cancer
• Solid Tumors

Intervention

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

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of peripheral tumor lesions identified in standard PET/CT imaging also identifiable in PEM images.	Study considered a success if 70% of lesions identified using standard images are also identifiable in the PEM image.	20 minutes for imaging using PEMFlex Solo II	No

External Links

•   University of Texas MD Anderson Cancer Center Website