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

NCT01008930 | Completed

• 2 other identifiers: 2009-0478NCI-2011-02894
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumors; Cancer

Keywords

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)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

PEM Scan

EXPERIMENTAL

HR PEM images (High Resolution PEMFlex Solo II scan images)

Procedure: HR PEM Scan

Interventions

HR PEM Scan PROCEDURE

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

Also known as: HR PET/CT Scan, PET/CT Imaging, PET, CT, Computed Tomography

PEM Scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A signed informed consent.
• 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.
• Scheduled for routine clinical imaging at the ACB PET/CT facility.
• Participant must be at least 18 years of age.

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77070, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Neoplasms

Study Officials

• Eric Rohren, MD

  UT MD Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2009
• First Posted: November 6, 2009
• Study Start: December 1, 2009
• Primary Completion: August 1, 2014
• Last Updated: August 20, 2014

Record last verified: 2014-08

Locations

US (1)