Head and Neck Cancer Clinical Trial
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
NCT number | NCT01030497 |
Other study ID # | 2009-0477 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | December 9, 2009 |
Last updated | May 13, 2014 |
Start date | December 2009 |
Verified date | May 2014 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1 |
Est. completion date | |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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.). |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of peripheral tumor lesions identified in standard PET/CT imaging also identifiable in PEM images. | 20 minutes for imaging using PEMFlex Solo II, within ± 30 days of standard PET/CT imaging | No |
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