Non-Small-Cell-Lung Cancer (NSCLC) Clinical Trial
Official title:
Prognostic Value of Tumor Hypoxia, as Measured by 18F-FMISO Breath Hold PET/CT, in Non-Small-Cell-Lung Cancer (NSCLC) Patients
| Verified date | January 2024 |
| Source | Memorial Sloan Kettering Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 29 |
| Est. completion date | December 2024 |
| Est. primary completion date | December 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Memorial Sloan Kettering Cancer Center | National Cancer Institute (NCI), National Institutes of Health (NIH) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | prognostic value of fluorine-18-labeled fluoro-misonidazole (18F-FMISO) | Breathing Hold and Free-Breathing (FB), dynamic 18F-FMISO PET images. | 2 years | |
| Primary | progression-free survival (PFS) | 3 years | ||
| Secondary | overall survival | 3 years |