N/A
Completed N=25
Prognostic Value of Tumor Hypoxia, as Measured by 18F-FMISO Breath Hold PET/CT, in Non-Small-Cell-Lung Cancer (NSCLC) Patients
Source: ClinicalTrials.gov NCT02016872 ↗Enrolled (actual)
25
Serious AEs
8.0%
Results posted
Apr 2025
Primary outcomePrimary: The Difference Between Two Baseline Fluorine-18-labeled Fluoro-misonidazole (18F-FMISO) Scans — 0; 0 unitless
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Difference Between Two Baseline Fluorine-18-labeled Fluoro-misonidazole (18F-FMISO) Scans |
0; 0 | — |
| PRIMARY Progression-free Survival (PFS) |
58.3 | — |
| SECONDARY Overall Survival |
40 | — |
Eligibility Criteria
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
Exclusion Criteria
- Women who are pregnant or breast-feeding
- Severe diabetes (fasting Blood Glucose > 200 mg/dl)
Data sourced from ClinicalTrials.gov (NCT02016872). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.