Comparison of PEM Uptake Value (PUV) and Standardized Uptake Value (SUV) in Patients With Malignancies of the Breast

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01031238
First received: December 10, 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 positron emission tomography (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/computed tomography (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
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pilot Study to Compare the PEM Uptake Value (PUV) and Standardized Uptake Value (SUV) in Patients With Malignancies of the Breast

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Correlation between PUV and SUV of breast malignancies in patients undergoing [18F]-FDG-PET/CT scanning [ Time Frame: 20 minutes for imaging using PEMFlex Solo II ] [ Designated as safety issue: No ]
    Formal quantitative assessment of the correlation between PUVmax values and SUVmax values performed by testing whether the Pearson correlation between these values exceeds 0.7.


Estimated Enrollment: 24
Study Start Date: December 2009
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
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 your breast that has, or is suspected to have cancer. To take images using the PEMFlex Solo II, the breast is placed between two flat panels on the scanning machine and compressed (flattened). The position of the breast for this procedure is similar to getting a mammogram, but the PEMFlex Solo II uses about 50% less force to compress the breast(s). The compression will be repeated on the other breast if you are having scans of both breasts performed.

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 for PET scan imaging of the breast.

Up to 24 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
Sampling Method:   Non-Probability Sample
Study Population

Patients with known or suspected tumors of the breast, 18 years or older scheduled for routine clinical imaging at the PET/CT facility.

Criteria

Inclusion Criteria:

  1. A signed informed consent.
  2. Known or suspected malignancy involving the breast 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: NCT01031238

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Eric Rohren, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01031238     History of Changes
Other Study ID Numbers: 2009-0479
Study First Received: December 10, 2009
Last Updated: August 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
PEM Uptake Value
PUV
Standardized Uptake Value
SUV
Malignancies of the Breast
[18F]-FDG-PET/CT scanning
Tumor
positron emission tomography/computed tomography
PET/CT scan

Additional relevant MeSH terms:
Neoplasms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014