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 Fluorothymidine (FLT PET), in the early treatment
evaluation of head and neck cancer. FLT uptake in the tumor correlates with the rate of cell
proliferation. It is therefore hoped that changes in tumor FLT uptake after therapy will
reflect change in the number of actively dividing tumor cells and will provide early
assessment of treatment response.
Research subjects will undergo one PET scan with FLT. The scan is done prior to any
therapeutic intervention (radiation or chemotherapy) can be obtained up to 30 days prior to
the start of therapy. The uptake of FLT in the tumor will be analyzed to see if it can be
used as a predictor of treatment efficacy and/or outcome.
There is an optional biopsy component to this study. Should the attending physicians
(primarily the otolaryngologists) believe that the subject can safely undergo an outpatient
biopsy, and the subject agrees, a biopsy is performed. The biopsy will be done within 30 days
prior to treatment, similar to FLT PET scans. Tissue from the biopsy will be analyzed for
markers of cellular proliferation and these markers will be correlated with the findings of
FLT PET scan.
There will be a 2-year clinical follow-up to assess for treatment outcomes, local control,
and overall survival.
- Ability to understand and willingness to sign a written informed consent document.
- Subject must have histologically confirmed squamous cell carcinoma of the head and
- 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.
- 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