A Multi - Center Study Of PET Imaging With [F-18] FLT & [F-18] FDG in Cancer Patients for Treatment Evaluation
- Conditions
- Lung CancerHead and Neck Cancer
- Interventions
- Drug: [F-18]FLT
- Registration Number
- NCT00847509
- Lead Sponsor
- Siemens Molecular Imaging
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FLT PET scan [F-18]FLT 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.
- Primary Outcome Measures
Name Time Method [F-18]FLT PET Scan for Early Assessment of Tumor Response to Radiation or Chemoradiotherapy Compared to [F-18] FDG PET Scan 3-5 weeks after the start of radiation or chemo radio therapy The sponsor decided not to further develop \[F-18\]FLT. Therefore, no further analysis was performed.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Excel Diagnostics Imaging Clinics
🇺🇸Houston, Texas, United States
Hoag Memorial Hospital
🇺🇸Newport Beach, California, United States