Prognostic Value of Tumor Hypoxia, as Measured by 18F-FMISO Breath Hold PET/CT, in Non-Small-Cell-Lung Cancer (NSCLC) Patients
Not Applicable
Completed
- Conditions
- Non-Small-Cell-Lung Cancer (NSCLC)
- Interventions
- Drug: 18F-FMISOOther: PET/CT
- Registration Number
- NCT02016872
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief Summary
The purpose of this study is to help researchers investigate if a new imaging agent named 18F-FMISO can predict if patients with lung cancer will respond to standard therapy, as well as whether disease will reoccur in the future. The study will also investigate whether a 18F-FDG PET scan in the middle of radiation treatment can predict if lung cancer will respond to standard therapy. Information obtained from this study may help doctors design future studies in which they may target tumor areas that do not respond to therapy or may likely reoccur in the future.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
Inclusion Criteria
- Pathologic confirmation of NSCLC at MSKCC
- No prior treatment for this diagnosis of NSCLC
- Patient to be treated with neoadjuvant chemotherapy (35 patients total) or patient to be treated with definitive RT,sequential chemo-RT, or concurrent chemo-RT (minimum dose of 50 Gy in 25 fractions) (25 patients total)
- Tumor must measure ≥ 2cm on CT
- Age ≥ 18 years
- Ability to hold the breath for 10 seconds.
- Karnofsky performance status ≥ 70%
- Women of childbearing age must have a negative blood pregnancy test
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Exclusion Criteria
- Women who are pregnant or breast-feeding
- Severe diabetes (fasting Blood Glucose > 200 mg/dl)
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 18F-FMISO PET/CT 18F-FMISO All enrolled patients will undergo a baseline 18F-FDG PET scan as part of their standard clinical treatment for NSCLC. Dynamic 18F-FMISO PET scans will be performed on one of the GE PET/CT scanners in 3D mode, at least one day after the baseline 18F-FDG PET scan. The dynamic baseline 18F-FMISO studies may precede the 18F-FDG study if the patient had a CT or PET/CT scan within the last 30 days that would permit the investigators to localize the tumor of interest during the 18F-FMISO study. In a group of 5 patients, the feasibility of simultaneous imaging of 18F-FMISO and 18F-FDG will be assessed. The patient will have an IV line placed for radiotracer injection and for venous blood sampling. All dynamic PET scans will be performed over one PET FOV centered at the lesion position. The 18F-FDG mid-treatment PET/CT scan will be performed over only one bed position. 18F-FMISO PET/CT PET/CT All enrolled patients will undergo a baseline 18F-FDG PET scan as part of their standard clinical treatment for NSCLC. Dynamic 18F-FMISO PET scans will be performed on one of the GE PET/CT scanners in 3D mode, at least one day after the baseline 18F-FDG PET scan. The dynamic baseline 18F-FMISO studies may precede the 18F-FDG study if the patient had a CT or PET/CT scan within the last 30 days that would permit the investigators to localize the tumor of interest during the 18F-FMISO study. In a group of 5 patients, the feasibility of simultaneous imaging of 18F-FMISO and 18F-FDG will be assessed. The patient will have an IV line placed for radiotracer injection and for venous blood sampling. All dynamic PET scans will be performed over one PET FOV centered at the lesion position. The 18F-FDG mid-treatment PET/CT scan will be performed over only one bed position.
- Primary Outcome Measures
Name Time Method prognostic value of fluorine-18-labeled fluoro-misonidazole (18F-FMISO) 2 years Breathing Hold and Free-Breathing (FB), dynamic 18F-FMISO PET images.
progression-free survival (PFS) 3 years
- Secondary Outcome Measures
Name Time Method overall survival 3 years
Trial Locations
- Locations (1)
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States