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A Phase II/III, Open Label, Non-Randomized, Multi - Center Study Of Positron Emission Tomography (PET) 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
Lung Cancer, Head and Neck Cancer

Thank you

Trial Information

A Phase II/III, Open Label, Non-Randomized, Multi - Center Study Of Positron Emission Tomography (PET) Imaging With [F-18] FLT Compared to [F-18] FDG in Cancer Patients for Treatment Evaluation


PHASE: II/III

OBJECTIVES:

Primary: To investigate the clinical value of serial quantitative [F-18] FLT positron image
assessment of tumor proliferation rates for early assessment of tumor response to radiation
or chemoradiotherapy regimens (except with 5-fluorouracil) in comparison to serial
quantitative [F-18] FDG images

Secondary: To gain additional clinical information and experience with [F-18]FLT to guide
the design of a future, pivotal, Phase III trial where changes in tumor proliferation from
pre-treatment baseline values can be used as a early indicator of response to therapy
regimens.

DESIGN: Open label, nonrandomized, uncontrolled, single group assignment

DURATION: Pre treatment [F-18] FLT PET scan following a clinical [F-18] FDG PET scan
followed by post treatment [F-18] FLT PET scan and a post treatment, clinical [F-18] FDG PET
scan at 4 weeks (±1 week) to monitor radiotherapy or chemoradiotherapy.

PROCEDURES: Informed consent, collection of demographic information, medical history,
physical examinations, vital signs, 12-lead ECGs, concomitant medication collection, monitor
adverse events, pre treatment [F-18] FLT PET scan and post treatment [F-18] FLT PET scan

SUBJECTS: Approximately 60 patients will be enrolled with confirmed lung cancer, or head and
neck cancer. The patients must also be starting radiotherapy or a chemoradiotherapy regimen
(except with 5-fluorouracil) to be eligible. This allows for approximately 40 evaluable
patients to complete this study at approximately four to eight sites and conducted in the
United States.


Inclusion Criteria:



- Patient provides written Informed Consent and is willing to comply with protocol
requirements

- Patient is at least 18 years of age on the day of dosing (male or female of any race
or ethnicity)

- Patient is capable of lying still in the PET scanner for the protocol required time
frame(s)

- Patient has a diagnosis of one of the following malignancies using the 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)

- 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

- Patient is scheduled to start radiotherapy or a chemoradiotherapy regimen for
curative intent

- 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)

- 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

- Patient has not received or intends to receive 5-fluorouracil (chemotherapeutic
agent)

- Patient has a score of greater than or equal to (>/=) 60% on the Karnofsky
Performance Status Scale

Exclusion Criteria:

- Patient is a pregnant or lactating female. 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

- Patient is undergoing treatment with palliative intent

- Patient has received an investigational compound and/or medical device within 14 days
before admission into this study

- 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

- 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: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To measure if the clinical value with quantitative [F-18] FLT PET positron images for tumor proliferation rates for early assessment of tumor response to radiation or chemoradiotherapy regimens in comparison to quantitative [F-18] FDG PET images

Outcome Time Frame:

3-5 weeks after the start of radiation or chemo radio therapy

Safety Issue:

No

Principal Investigator

Ebrahim S Delpassand, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Excel Diagnostics Imaging Clinics

Authority:

United States: Food and Drug Administration

Study ID:

FLT101

NCT ID:

NCT00847509

Start Date:

February 2009

Completion Date:

September 2010

Related Keywords:

  • Lung Cancer
  • Head and Neck Cancer
  • lung cancer
  • head and neck cancer
  • radiotherapy
  • chemoradiotherapy
  • radiation
  • chemoradiation
  • FLT
  • [F-18]FLT
  • FDG
  • [F-18]FDG
  • Head and Neck Neoplasms
  • Lung Neoplasms

Name

Location

HOAG Memorial HospitalNewport Beach, California  92658-6100
Excel Diagnostics Imaging ClinicsHouston, Texas  77042