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NCT00721799 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Head and Neck Neoplasms and Oropharyngeal Neoplasms, sponsored by University of Iowa.

Completed
Registry status
Phase 2
Development phase
33
Enrollment target
1
Study location

NCT00721799: Completed Phase 2 study of Head and Neck Neoplasms and Oropharyngeal Neoplasms, sponsored by University of Iowa.

NCT00721799 is a Phase 2 study of Head and Neck Neoplasms and Oropharyngeal Neoplasms that has completed, run by University of Iowa. The registered enrollment target is 33 participants, below the 264-participant average among 23 other Head and Neck Neoplasms trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00721799, a Phase 2 study of Head and Neck Neoplasms and Oropharyngeal Neoplasms, has completed, sponsored by University of Iowa.

COMPLETED
Registry status
Phase 2
Development phase
33 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.

Conditions Studied

Head and Neck Neoplasms Oropharyngeal Neoplasms Mouth Neoplasms Laryngeal Neoplasms

Interventions

  • DRUG 18F-Fluorothymidine PET scan

Study Locations (1)

Iowa

  • University of Iowa Hospitals and Clinics - Iowa City

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2008-03-01
Est. Completion 2014-12-31
Phase Phase 2
University of Iowa

228 total trials

What the finished NCT00721799 record still lists

NCT00721799 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 264-participant average among 23 other Head and Neck Neoplasms trials with a reported enrollment target (87% lower).

The record links to 4 conditions, with Head and Neck Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which 18F-Fluorothymidine PET scan is the first listed.

NCT00721799 reports a single indexed study location in Iowa.

Frequently Asked Questions

What is clinical trial NCT00721799 about?

NCT00721799 is a clinical study titled "F-18 Fluorothymidine PET Imaging for Early Evaluation of Response to Therapy in Head & Neck Cancer Patients". 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 co...

What is the current status of trial NCT00721799?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2008-03-01. Estimated completion is 2014-12-31.

What conditions does trial NCT00721799 study?

This clinical trial studies the following conditions: Head and Neck Neoplasms, Oropharyngeal Neoplasms, Mouth Neoplasms, Laryngeal Neoplasms.

What interventions are being tested in trial NCT00721799?

The interventions under investigation include: 18F-Fluorothymidine PET scan (DRUG).

Who is sponsoring clinical trial NCT00721799?

This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00721799 being conducted?

This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Head and Neck Neoplasms

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00721799's enrollment target sits among peer trials

33 16th of 23 higher than 8 of 23 other Head and Neck Neoplasms trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Head and Neck Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00721799, the US trial registry maintained by the National Library of Medicine. NCT00721799 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.