- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00847509
A Multi - Center Study Of PET Imaging With [F-18] FLT & [F-18] FDG in Cancer Patients for Treatment Evaluation (FLT101)
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Newport Beach, California, United States, 92658
- Hoag Memorial Hospital
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Texas
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Houston, Texas, United States, 77042
- Excel Diagnostics Imaging Clinics
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
[F-18]FLT PET Scan for Early Assessment of Tumor Response to Radiation or Chemoradiotherapy Compared to [F-18] FDG PET Scan
Time Frame: 3-5 weeks after the start of radiation or chemo radio therapy
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The sponsor decided not to further develop [F-18]FLT.
Therefore, no further analysis was performed.
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3-5 weeks after the start of radiation or chemo radio therapy
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ebrahim S Delpassand, MD, Excel Diagnostics Imaging Clinics
- Principal Investigator: Michael Brandt-Zawadzki, MD, Hoag Memorial Hospital, Newport Beach, CA
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FLT101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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