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

Completed · Not applicable

Conditions studied: Lung Cancer, Head and Neck Cancer

In brief

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.

Key facts

Study ID

NCT00847509

Run by

Siemens Molecular Imaging

People needed

49

Starts

2009-02-01

Expected to finish

2010-09-01

Last updated by the study team

2013-09-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Hoag Memorial Hospital — Newport Beach, California, United States
• Excel Diagnostics Imaging Clinics — Houston, Texas, United States

Full record on ClinicalTrials.gov

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