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Biodistribution and Radiation Dosimetry of F-18 Fluorothymidine (FLT) Imaged With Positron Emission Tomography (PET) in Patients With Head and Neck Cancer: A Radioactive Drug Research Committee (RDRC) Study

Phase 1
21 Years
Not Enrolling
Head and Neck Cancer

Thank you

Trial Information

Biodistribution and Radiation Dosimetry of F-18 Fluorothymidine (FLT) Imaged With Positron Emission Tomography (PET) in Patients With Head and Neck Cancer: A Radioactive Drug Research Committee (RDRC) Study

There are approximately 40,000 new cases of head and neck cancer each year in the United
States. Worldwide more than 500,000 individuals will develop head and neck cancer each year,
ranking as the sixth most common cancer. These cancers are predominately squamous cell
cancers. Approximately two thirds of subjects will present with locally advanced disease
with either large disease at the primary site and/or spread to regional lymph node levels.

Despite aggressive treatment, 5-year survival remains poor (overall, approximately 50%). The
major site of treatment failure is within the head and neck region, with distant metastases
occurring in approximately 25% of subjects and usually after local and/or regional (nodal)

Current treatment options for locally advanced head and neck cancer include combinations of
surgery, radiation therapy, and chemotherapy. It is currently difficult to predict which
combination will be best suited for any particular individual. Rapid methods of assessing
the response of subjects to chemo-radiotherapy would be a useful tool, as it would permit
the oncologist to change therapies, either in type or degree, in cases when the subject does
not respond to the initial therapy regimen. Current best methods of evaluating tumor
response are either serial CT examinations, so that changes in tumor size can be estimated
or a fluorodeoxyglucose (FDG) positron emission tomography (PET) study in which changes in
the metabolic status of the tumor are evaluated. Unfortunately, the anatomic information
afforded by CT examinations often require months after treatment to allow the full effects
of therapy to take place. Even after this time, the metabolic activity of any remaining
tissue is nearly impossible to assess by CT scan, making it difficult to distinguish between
fibrosis and viable tissue. Generally the FDG studies require 3-4 weeks after the end of the
therapeutic regime before the relevant information is available, with more reliable
information obtained at 3-4 months after treatment.

It is predictable that the most immediate signal of an anti-tumor therapeutic regime that
has been successful is that the tumor cells will stop dividing (proliferating) after the
therapy is initiated. Therefore, a tracer which is taken up into and retained in cells as a
function of their proliferative activity should provide rapid information as to the
effectiveness of the treatment. It is the objective of this study to determine the
biodistribution and radiation dosimetry of tracer F-18 3`-deoxy-3`-fluorothymidine. This
distribution data is essential before an Investigational New Drug (IND) application can be
filed with the FDA that would allow the use of this tracer in clinical trials.

Inclusion Criteria:

1. Ability to understand and willingness to sign a written informed consent document.

2. Subject must have histologically confirmed stage III, or IV squamous cell carcinoma
of the head and neck whose primary origin was from the oral cavity, oropharynx,
hypopharynx, or larynx. Carcinoma must be staged using the American Joint Committee
on Cancer (AJCC) staging criteria version 6. Adequate tumor must be amenable to
biopsy via outpatient methods, therefore the majority of subjects will be those with
oropharyngeal lesions.

3. Subjects 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.

4. Males or females greater than or equal to 21 years of age. Squamous cell cancer of
the head and neck is exceedingly rare in children and not generally applicable to the
pediatric population.

5. Karnofsky score greater than or equal to 60% at time of screening.

6. Life expectancy of greater than 6 months.

7. Subject must have normal organ and marrow function as defined below:

- leukocytes greater than or equal to 3,000/microL

- absolute neutrophil count greater than or equal to 1,500/microL

- platelets greater than or equal to 100,000/microL

- total bilirubin within normal institutional limits

- AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of

- creatinine within normal institutional limits

- BUN within normal institutional limits

- PT and PTT < 2.0 X upper normal limits

8. 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 to women of childbearing
potential before each FLT scan.

Exclusion Criteria:

1. 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.

2. Subject may not be receiving any other investigational agents.

3. Subject with a Karnofsky score below 60.

4. Pregnant women are excluded from this study. FLT PET has the 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.

5. Subject with an inadequate marrow reserve as determined by history and/or the above

6. Subject with a bleeding or clotting dysfunction as determined by medical history and
above tests.

7. Subjects taking nucleoside analog medications such as those used as antiretroviral

8. Inadequate tumor volume to allow for 2 biopsies.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

Yusuf Menda, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Iowa, Department of Radiology-Nuclear Medicine


United States: Institutional Review Board

Study ID:




Start Date:

October 2005

Completion Date:

April 2008

Related Keywords:

  • Head and Neck Cancer
  • Head and Neck cancer
  • Squamous cell carcinoma
  • FLT
  • Fluorothymidine
  • F-18
  • Head and Neck Neoplasms



University of Iowa Hospitals and ClinicsIowa City, Iowa  52242