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

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Siemens Molecular Imaging

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.