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A Multi - Center Study Of PET Imaging With [F-18] FLT & [F-18] FDG in Cancer Patients for Treatment Evaluation (FLT101)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Siemens Molecular Imaging
ClinicalTrials.gov Identifier:
NCT00847509
First received: February 17, 2009
Last updated: August 23, 2012
Last verified: August 2012
History of Changes
  Purpose

Approximately 60 patients will be enrolled with highly suspected lung cancer, or head and neck cancer. The patients must also be starting radiotherapy or a chemoradiotherapy regimen (except with 5-fluorouracil). The patients will undergo 3 visits. One screening, one pre therapy PET/CT imaging visit, and one (3-5 weeks after the start of therapy) post PET/CT imaging visit. This study will evaluate the FLT and FDG images for tumor proliferation rates for early assessment of tumor response to radiation or chemo-radiation combo.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence 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 (PET) Imaging With [F-18] FLT Compared to [F-18] FDG in Cancer Patients for Treatment Evaluation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Siemens Molecular Imaging:

Primary Outcome Measures:
  • 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 [ Time Frame: 3-5 weeks after the start of radiation or chemo radio therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gain additional clinical information and experience with [F-18] FLT PET to guide the design of a pivotal, Phase III trial where changes in tumor proliferation from pre-treatment values can be used as a early indicator of response to therapy regimens [ Time Frame: 3-5 weeks after the start of radiation or chemo radio therapy ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: February 2009
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FLT PET scan
Open label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate [F-18] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard [F-18] FDG PET will be the active comparator.
 Drug: [F-18]FLT
The individual doses of [F-18]FLT contain a maximum of 10 mCi. The single IP dose is administered to the study subject approximately 30 to 60 minutes prior to the start of PET imaging.
Other Names:
  • [F-18] FLT
  • FLT

Detailed Description:

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.

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847509

Locations
United States, California
Hoag Memorial Hospital
Newport Beach, California, United States, 92658
United States, Texas
Excel Diagnostics Imaging Clinics
Houston, Texas, United States, 77042
Sponsors and Collaborators
Siemens Molecular Imaging
Investigators
Principal Investigator: Ebrahim S Delpassand, MD Excel Diagnostics Imaging Clinics
Principal Investigator: Michael Brandt-Zawadzki, MD Hoag Memorial Hospital, Newport Beach, CA
  More Information

No publications provided

Responsible Party: Siemens Molecular Imaging
ClinicalTrials.gov Identifier: NCT00847509     History of Changes
Other Study ID Numbers: FLT101
Study First Received: February 17, 2009
Last Updated: August 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Siemens Molecular Imaging:
lung cancer
head and neck cancer
radiotherapy
chemoradiotherapy
radiation
 chemoradiation
FLT
[F-18]FLT
FDG
[F-18]FDG

Additional relevant MeSH terms:
Head and Neck Neoplasms
Lung Neoplasms
Neoplasms by Site
Neoplasms
 Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 13, 2013