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Feasibility Study for Detection of Cervical Lymph Node Metastases With a High-Resolution PET Imaging System in Patients With Known or Suspected Cancers of the Upper Aerodigestive Tract


N/A
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

Thank you

Trial Information

Feasibility Study for Detection of Cervical Lymph Node Metastases With a High-Resolution PET Imaging System in Patients With Known or Suspected Cancers of the Upper Aerodigestive Tract


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 part of the neck that has, or is suspected to have 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 for PET
scan imaging of the breast. Using the PEMFlex Solo II for imaging any other parts of the
body is investigational.

Up to 28 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 primary cancer of the upper aerodigestive tract, which may be
determined by biopsy, physical examination- including upper endoscopy or noninvasive
imaging studies including CT, MR, ultrasound, or prior PET.

3. Known or suspected metastatic disease to cervical lymph nodes based on physical
examination, imaging studies or biopsy.

4. Scheduled for routine clinical imaging at the ACB PET/CT facility.

5. Participant must be at least 18 years of age.

Exclusion Criteria:

1. Prior treatment (chemotherapy, radiotherapy) for cancer of the upper aerodigestive
tract.

2. Prior biopsy procedures, including resection of the primary cancer, will not exclude
the patient from participation.

3. Uncontrolled blood glucose levels (>200 mg/dl).

4. Patient is unable to comprehend the requirements of the study.

5. Patient is unable to undergo scanning of the neck with the 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:

Number of peripheral tumor lesions identified in standard PET/CT imaging also identifiable in PEM images.

Outcome Time Frame:

20 minutes for imaging using PEMFlex Solo II, within ± 30 days of standard PET/CT imaging

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:

2009-0477

NCT ID:

NCT01030497

Start Date:

December 2009

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Cancer
  • Cervical Lymph Node Metastases
  • High-Resolution PET Imaging System
  • Upper Aerodigestive Tract
  • Head
  • Neck
  • HR PET Imaging System
  • High-Resolution PET
  • PET/CT
  • PEMFlex Solo II
  • positron emission tomography/computed tomography (PET/CT)
  • Head and Neck Neoplasms
  • Neoplasm Metastasis

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030