Standard and Delayed FDG PET/CT Before and After Chemoradiation Therapy in Assessing Patients With Metastatic Head and Neck Squamous Cell Cancer
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 11/24/2018 |
| Start Date: | June 15, 2018 |
| End Date: | December 31, 2019 |
| Contact: | Jason Johnson |
| Email: | jjohnson12@mdanderson.org |
| Phone: | 713-792-8443 |
Dual-Time Point (DTP) FDG PET CT for the Post-Treatment Assessment of Head and Neck Tumors Following Definitive Chemoradiation Therapy
This trial studies how well standard and delayed fludeoxyglucose F-18 (FDG)-positron emission
tomography (PET)/computed tomography (CT) given before and after standard radiation and
chemotherapy, works in assessing patients with head and neck squamous cell cancer that has
spread to other places in the body. Diagnostic procedures, such as PET/CT, use radioactive
material, such as fludeoxyglucose F-18, to find and diagnose head and neck tumors and may
help to find out how far the disease has spread.
tomography (PET)/computed tomography (CT) given before and after standard radiation and
chemotherapy, works in assessing patients with head and neck squamous cell cancer that has
spread to other places in the body. Diagnostic procedures, such as PET/CT, use radioactive
material, such as fludeoxyglucose F-18, to find and diagnose head and neck tumors and may
help to find out how far the disease has spread.
PRIMARY OBJECTIVES:
I. To assess the optimal imaging time using FDG positron emission tomography (PET) with
comparison between a standard of care 1-hour scan (early) and the research scan of 3-hours
scan (delayed) post radiotracer administration that maximizes separation of activity between
lesion and non-lesional parenchyma (measured as lesion/background [L/B] ratio) in patients
with head and neck primary squamous cell carcinoma prior to and following chemoradiation
treatment.
OUTLINE:
Patients receive fludeoxyglucose F-18 intravenously (IV) over 1 minute and undergo PET/CT at
70 and 180 minutes after injection within 4 weeks prior to receiving standard chemoradiation
(CRT) and then again at 12 weeks following CRT completion.
After completion of study, patients are followed up at 30 days and then periodically for up
to 6 months.
I. To assess the optimal imaging time using FDG positron emission tomography (PET) with
comparison between a standard of care 1-hour scan (early) and the research scan of 3-hours
scan (delayed) post radiotracer administration that maximizes separation of activity between
lesion and non-lesional parenchyma (measured as lesion/background [L/B] ratio) in patients
with head and neck primary squamous cell carcinoma prior to and following chemoradiation
treatment.
OUTLINE:
Patients receive fludeoxyglucose F-18 intravenously (IV) over 1 minute and undergo PET/CT at
70 and 180 minutes after injection within 4 weeks prior to receiving standard chemoradiation
(CRT) and then again at 12 weeks following CRT completion.
After completion of study, patients are followed up at 30 days and then periodically for up
to 6 months.
Inclusion Criteria:
- Adult with pathology proven cervical nodal metastasis from a head and neck primary
squamous cell carcinoma with planned treatment with definitive chemoradiation
Exclusion Criteria:
- Children
- No evidence of cervical nodal metastasis
- Active infection of the head and neck
- Known allergy to FDG, iodine or gadolinium-based contrast agents
- Blood glucose (> 200 mg/dl)
- Severe renal dysfunction (glomerular filtrate rate [within 30 days] less than 30)
- Pregnant women
We found this trial at
1
site
Houston, Texas 77030
Principal Investigator: Jason M. Johnson
Phone: 713-792-8443
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