F-18 Fluorothymidine PET Imaging for Early Evaluation of Response to Therapy in Head & Neck Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Yusuf Menda, University of Iowa
ClinicalTrials.gov Identifier:
NCT00721799
First received: June 10, 2008
Last updated: May 21, 2014
Last verified: May 2014
  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 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.


Condition Intervention Phase
Mouth Neoplasms
Oropharyngeal Neoplasms
Laryngeal Neoplasms
Head and Neck Neoplasms
Drug: F-18 Fluorothymidine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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)

Resource links provided by NLM:


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: March 2015
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FLT PET
Subjects who receive F-18 Fluorothymidine [FLT]PET imaging prior to treatment.
Drug: F-18 Fluorothymidine
FLT PET scan [0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%)]
Other Names:
  • FLT
  • FLT PET

  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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721799

Locations
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
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
  More Information

Additional Information:
Publications:
Responsible Party: Yusuf Menda, Associate Professor, Radiology-Nuclear Medicine, University of Iowa
ClinicalTrials.gov Identifier: NCT00721799     History of Changes
Other Study ID Numbers: 200801758, 1R21CA130281
Study First Received: June 10, 2008
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Iowa:
Positron-Emission Tomography

Additional relevant MeSH terms:
Neoplasms
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Laryngeal Neoplasms
Mouth Neoplasms
Oropharyngeal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Otorhinolaryngologic Neoplasms
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Mouth Diseases
Stomatognathic Diseases
Pharyngeal Neoplasms
Pharyngeal Diseases

ClinicalTrials.gov processed this record on July 22, 2014