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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


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

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.

Outcome Time Frame:

1 year

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

HS# 2009-6857

NCT ID:

NCT00894101

Start Date:

May 2009

Completion Date:

April 2010

Related Keywords:

  • Head and Neck Cancer
  • Head and Neck Neoplasms

Name

Location

Department of Radiology, UCI Medical Center Orange, California  92868