Status:
COMPLETED
F-18 Fluorothymidine PET Imaging for Early Evaluation of Response to Therapy in Head & Neck Cancer Patients
Lead Sponsor:
University of Iowa
Collaborating Sponsors:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Conditions:
Mouth Neoplasms
Oropharyngeal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an imaging protocol only, not a therapeutic study. The primary goal of the proposed study is to examine the utility of a new imaging study, Positron Emission Tomography with F-18 Fluorothymid...
Detailed Description
There are approximately 40,000 new cases of head and neck cancer each year in the United States. Approximately two thirds of these patients present with locally advanced disease with either large dise...
Eligibility Criteria
Inclusion
- Ability to understand and willingness to sign a written informed consent document.
- Subject must have histologically confirmed squamous cell carcinoma of the head and neck.
- Subject must be scheduled to receive combined chemo-radiotherapy treatment for their standard cancer care. Treatment decisions will be made by the treating otolaryngologist, radiation, and medical oncologists.
- Male or females ≥ 18 years of age. Squamous cell cancer of the head and neck is exceedingly rare in children and not generally applicable to the pediatric population.
- Karnofsky greater than or equal to 60% at time of screening.
- Life expectancy of greater than 6 months.
- Subject must have normal organ and marrow function (as defined below) within 30 days of study enrollment:
- leukocytes ≥ 3,000/μL
- absolute neutrophil count ≥1,500/μL
- platelets ≥ 100,000/μL
- total bilirubin ≤ 1.0 mg/dl\*
- Either AST OR ALT ≤ 2.5 X institutional upper limit of normal
- creatinine ≤ 1.5 x institutional upper limit of normal
- PT and PTT (if biopsy is to be performed) \< 2.0 X upper normal limits
- The effects of FLT on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A screening urine hCG will be administered in the Nuclear Medicine to women of childbearing potential before each FLT scan and pregnant women will not be accepted as subjects in this study.
Exclusion
- Subjects who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Subject may not be receiving any other investigational agents.
- Subject with a Karnofsky score of below 60.
- Pregnant women are excluded from this study. FLT PET has potential for teratogenic effects. Because there are potentially unknown risks for adverse events in nursing infants secondary to treatment of the mother with FLT, breastfeeding should be discontinued if the mother is imaged with FLT and may not resume for 48 hours after the FLT imaging.
- Subjects taking nucleoside analog medications such as those used as antiretroviral agents.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2014
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00721799
Start Date
March 1 2008
End Date
December 31 2014
Last Update
August 6 2019
Active Locations (1)
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1
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242