Positron Emission Tomography Imaging With [F-18] FLT Compared to [F-18] FDG in Cancer Patients for Treatment Evaluation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00894101
Recruitment Status : Withdrawn (The main sponsor of this multi-center trial has submitted this protocol. A single participating site should not register this study.)
First Posted : May 6, 2009
Last Update Posted : April 4, 2011
Information provided by:
University of California, Irvine

May 4, 2009
May 6, 2009
April 4, 2011
May 2009
April 2010   (Final data collection date for primary outcome measure)
The basic safety data of [F-18] FLT tracer will be collected. The treatment response evaluated based on the [F-18] FLT results will be compared to the response evaluated based on the standard PET trace [F-18] FDG. [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT00894101 on Archive Site
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Positron Emission Tomography Imaging With [F-18] FLT Compared to [F-18] FDG in Cancer Patients for Treatment Evaluation
A Phase II/III, Open Label, Non-Randomized, Multi-Center Study of Positron Emission Tomography Imaging With [F-18] FLT Compared to [F-18] FDG in Cancer Patients for Treatment Evaluation
The purpose of this study is to investigate the clinical value of serial quantitative [F-18] FLT as a PET imaging tool in head and neck cancer patients clinically scheduled with radiation or radiation-chemotherapy combination in terms of safety and efficacy. Standard [F-18] FDG PET will be the active comparator.
Not Provided
Phase 2
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Head and Neck Cancer
Drug: [F-18] FLT
10 mCi [F-18] FLT and 10 mCi [F-18] FDG will be used for PET imaging.
Experimental: [F-18] FLT and FDG
Intervention: Drug: [F-18] FLT
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
April 2010
April 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patient provides written Informed Consent and is willing to comply with protocol requirements
  2. Patient is at least 18 years of age on the day of dosing (male or female of any race or ethnicity)
  3. Patient is capable of lying still in the PET scanner for the protocol required time frame(s)
  4. Patient has a diagnosis of one of the following malignancies (TNM Staging System):

    • Lung cancer (T3 grade up, node positive, but no metastatic disease)
    • Head and neck cancer (T3 grade up, node positive, but no metastatic disease)
  5. Patient has undergone a comparative, diagnostic procedure with lesion(s) visible, other than ultrasound, that includes, but is not limited to computed tomography (CT), magnetic resonance imaging (MRI), nuclear medicine imaging, endoscopy, laparoscopy, standard abdominal x-ray, biopsy and/or surgery for one of the above mentioned areas
  6. Patient is scheduled to start radiotherapy or a chemoradiotherapy regimen for curative intent
  7. As a part of his/her standard radiotherapy or chemoradiotherapy regimen, patient is scheduled to have clinical [F-18] FDG PET scans pre treatment and post treatment (at about 4 weeks (±1 week) after the start of therapy)
  8. Patient is scheduled to have the investigational, pre treatment [F-18] FLT PET scan recommended to be within ± 2 days of the clinical, pre treatment [F-18] FDG PET scan
  9. Patient has not received or intends to receive 5-fluorouracil (5-FU-chemotherapeutic agent)
  10. Patient has a score of greater than or equal to (≥) 60% on the Karnofsky Performance Status Scale

Exclusion Criteria:

Exclude a patient from this study if the patient does not fulfill the inclusion criteria, or if any of the following conditions are observed:

  1. Patient is a pregnant or lactating female. These methods will be used to exclude the possibility of pregnancy:

    • by testing on site at the institution (serum or urine βHCG) within 48 hours prior to the start of each investigational product administration,
    • by surgical history (eg, tubal ligation or hysterectomy),
    • by patient's history of being post menopausal with a minimum 1 year without menses.
  2. Patient is undergoing treatment with palliative intent
  3. Patient has received an investigational compound and/or medical device within 14 days before admission into this study
  4. Patient has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations
  5. Patient is determined by the Investigator that he/she is clinically unsuitable for the study.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
HS# 2009-6857
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Dr. Orhan Nalcioglu, Professor & Director, University of California, Irvine
University of California, Irvine
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Not Provided
University of California, Irvine
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP