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Pilot Study to Compare the PEM Uptake Value (PUV) and Standardized Uptake Value (SUV) in Patients With Malignancies of the Breast


N/A
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

Thank you

Trial Information

Pilot Study to Compare the PEM Uptake Value (PUV) and Standardized Uptake Value (SUV) in Patients With Malignancies of the Breast


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.


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.).

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Correlation between PUV and SUV of breast malignancies in patients undergoing [18F]-FDG-PET/CT scanning

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:

2009-0479

NCT ID:

NCT01031238

Start Date:

December 2009

Completion Date:

Related Keywords:

  • Breast Cancer
  • 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
  • Breast Neoplasms
  • Neoplasms

Name

Location

UT MD Anderson Cancer Center Houston, Texas  77030