F-18 Fluorothymidine PET Imaging for Early Evaluation of Response to Therapy in Head & Neck Cancer Patients
Condition: Mouth Neoplasms; Oropharyngeal Neoplasms; Laryngeal Neoplasms; Head and Neck Neoplasms
MeSH terms: Neoplasms; Head and Neck Neoplasms; Laryngeal Neoplasms; Oropharyngeal Neoplasms; Mouth Neoplasms
Intervention: 18F-Fluorothymidine PET scan
Intervention description: 18F-Fluorothymidine (0.04 - 0.08 mCi / kg to a maximum dose of 5 mCi) administered once intravenously for a positron emission tomography (PET) scan.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Positron-Emission Tomography; radiation therapy; cisplatin; chemotherapy; FLT

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 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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.