Clinical trial NCT01030497: Detection of Cervical Lymph Node Metastases With a High-Resolution Positron Emission Tomography (PET) Imaging System
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Keywords: 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)
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2009-12-11
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with known or suspected primary cancer of the upper aerodigestive tract or metastatic disease to cervical lymph nodes, over 18 years of age, and scheduled for routine clinical imaging at the PET/CT facility.

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.

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 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 10 patients will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility criteria: 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.).

Primary outcomes:
measure: Number of peripheral tumor lesions identified in standard PET/CT imaging also identifiable in PEM images.
timeFrame: 20 minutes for imaging using PEMFlex Solo II, within ± 30 days of standard PET/CT imaging
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Eric Rohren, MD
role: STUDY_CHAIR
References: