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F-18 Fluorothymidine PET Imaging for Early Evaluation of Response to Therapy in Head & Neck Cancer Patients
This study is currently recruiting participants.
Verified by University of Iowa, July 2008
Sponsors and Collaborators: University of Iowa
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by: University of Iowa
ClinicalTrials.gov Identifier: NCT00721799
  Purpose

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 two PET scans with FLT. The first 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 second FLT scan is done after the 5th radiation therapy session (before the 6th treatment). The change in uptake of FLT in the tumor between two PET scans 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, two biopsies are performed. Biopsies will be done within 30 days prior to treatment and after the 5th radiation therapy treatment and before the 6th 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 scans.

There will be a 2-year clinical follow-up to assess for treatment outcomes, local control, and overall survival.


Condition Intervention Phase
Mouth Neoplasms
Oropharyngeal Neoplasms
Laryngeal Neoplasms
Head and Neck Neoplasms
Drug: F-18 Fluorothymidine
Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer Nuclear Scans Oral Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: F-18 Fluorothymidine (FLT) PET Imaging for Early Evaluation of Response to Chemoradiation Therapy in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC)

Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Evaluate detection rate of primary and metastatic head & neck cancer sites with FLT PET imaging [ Time Frame: within the first month (+/- 5 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the efficacy of FLT PET imaging and change in FLT uptake for predicting outcome of treatment in terms of locoregional control and disease free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2008
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
FLT PET: Experimental
Subjects who receive FLT PET imaging prior to treatment and after 5 radiation treatments
Drug: F-18 Fluorothymidine
FLT PET scan 5 mCi (+/- 10%)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to understand and willingness to sign a written informed consent document.
  • 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.
  • 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*
  • AST(SGOT) ≤ 2.5 X institutional upper limit of normal
  • ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
  • creatinine ≤ 1.4 mg/dl*
  • BUN ≤ 20 mg /dl*
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00721799

Contacts
Contact: Yusuf Menda, M.D. (319) 356-3214 yusuf-menda@uiowa.edu
Contact: Jane Hershberger, RN, BSN (319) 384-7912 jane-hershberger@uiowa.edu

Locations
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Jane Hershberger, RN, BSN     319-384-7912     jane-hershberger@uiowa.edu    
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Yusuf Menda, M.D. The University of Iowa
Principal Investigator: John M. Buatti, M.D. The University of Iowa
Principal Investigator: Timothy Tewson, Ph.D. The University of Iowa
  More Information

The Holden Comprehensive Cancer Center  This link exits the ClinicalTrials.gov site

Responsible Party: Department of Radiology-Nuclear Medicine ( Yusuf Menda, M.D. )
Study ID Numbers: 200801758, 1R21CA130281
Study First Received: June 10, 2008
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00721799  
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Iowa:
Positron-Emission Tomography

Study placed in the following topic categories:
Mouth Diseases
Otorhinolaryngologic Neoplasms
Otorhinolaryngologic Diseases
Squamous cell carcinoma
Pharyngeal Neoplasms
Laryngeal Neoplasms
Pharyngeal Diseases
Mouth Neoplasms
Carcinoma
Epidermoid carcinoma
Respiratory Tract Diseases
Oral cancer
Head and Neck Neoplasms
Carcinoma, squamous cell
Laryngeal carcinoma
Laryngeal Diseases
Stomatognathic Diseases
Carcinoma, Squamous Cell
Carcinoma, squamous cell of head and neck
Oropharyngeal Neoplasms

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009