Prognostic Value of Tumor Hypoxia, as Measured by 18F-FMISO Breath Hold PET/CT, in Non-Small-Cell-Lung Cancer (NSCLC) Patients
Conditions
Non-Small-Cell-Lung Cancer (NSCLC)
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
PET/CT, 18F-FMISO, tumor hypoxia, 13-186
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: 18F-FMISO Type: Drug
Name: PET/CT Type: Other
Overall Status
Recruiting
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 on taking advantage of the low oxygen supply to the tumor tissue and improve outcomes in lung cancer patients.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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)

- Primary tumor or nodal tumor must measure ≥ 2 cm on CT (hilar and mediastinal LN excluded)

- 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)
Location
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Andreas Rimner, MD - 212-639-6025
Start Date
December 2013
Sponsors
Memorial Sloan Kettering Cancer Center
Source
Memorial Sloan Kettering Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page