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

This study has been withdrawn prior to enrollment.
(The main sponsor of this multi-center trial has submitted this protocol. A single participating site should not register this study.)
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00894101
First received: May 4, 2009
Last updated: April 1, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Drug: [F-18] FLT
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 7
Study Start Date: May 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: [F-18] FLT and FDG Drug: [F-18] FLT
10 mCi [F-18] FLT and 10 mCi [F-18] FDG will be used for PET imaging.

  Eligibility

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

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.
  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: NCT00894101

Locations
United States, California
Department of Radiology, UCI Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
  More Information

No publications provided

Responsible Party: Dr. Orhan Nalcioglu, Professor & Director, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00894101     History of Changes
Other Study ID Numbers: HS# 2009-6857
Study First Received: May 4, 2009
Last Updated: April 1, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 20, 2014