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F-18 Fluorothymidine (FLT) PET Imaging for Early Evaluation of Response to Chemoradiation Therapy in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC)

Phase 2
18 Years
Open (Enrolling)
Mouth Neoplasms, Oropharyngeal Neoplasms, Laryngeal Neoplasms, Head and Neck Neoplasms

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Trial Information

F-18 Fluorothymidine (FLT) PET Imaging for Early Evaluation of Response to Chemoradiation Therapy in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC)

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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Evaluate detection rate of primary and metastatic head & neck cancer sites with FLT PET imaging

Outcome Time Frame:

within the first month (+/- 5 days)

Safety Issue:


Principal Investigator

Yusuf Menda, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Iowa


United States: Food and Drug Administration

Study ID:




Start Date:

February 2008

Completion Date:

March 2015

Related Keywords:

  • Mouth Neoplasms
  • Oropharyngeal Neoplasms
  • Laryngeal Neoplasms
  • Head and Neck Neoplasms
  • Positron-Emission Tomography
  • Neoplasms
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Laryngeal Neoplasms
  • Mouth Neoplasms
  • Oropharyngeal Neoplasms



University of Iowa Hospitals and Clinics Iowa City, Iowa  52242