Non-Small-Cell-Lung Cancer (NSCLC)
Conditions
Keywords
PET/CT, 18F-FMISO, tumor hypoxia, 13-186
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.
Interventions
DRUG18F-FMISO
OTHERPET/CT
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Difference Between Two Baseline Fluorine-18-labeled Fluoro-misonidazole (18F-FMISO) Scans | 3 days from baseline | The difference between two baseline 18F-FMISO PET scans three days apart to assess the reproducibility. |
| Progression-free Survival (PFS) | 3 years | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival | 3 years |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 18F-FMISO 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. | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death Progression | 2 |
| Overall Study | Ineligible | 2 |
| Overall Study | No FMISO scan | 1 |
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | 18F-FMISO PET/CT |
|---|---|
| Age, Continuous | 64 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 25 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 25 |
| other Total, other adverse events | 2 / 25 |
| serious Total, serious adverse events | 2 / 25 |
Outcome results
Primary
Progression-free Survival (PFS)
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time frame: 3 years
Population: Participants who completed study treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 18F-FMISO PET/CT | Progression-free Survival (PFS) | 58.3 % of pts with progression free survival |
Primary
The Difference Between Two Baseline Fluorine-18-labeled Fluoro-misonidazole (18F-FMISO) Scans
The difference between two baseline 18F-FMISO PET scans three days apart to assess the reproducibility.
Time frame: 3 days from baseline
Population: Participants who completed study treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 18F-FMISO PET/CT | The Difference Between Two Baseline Fluorine-18-labeled Fluoro-misonidazole (18F-FMISO) Scans | k1 | 0 unitless |
| 18F-FMISO PET/CT | The Difference Between Two Baseline Fluorine-18-labeled Fluoro-misonidazole (18F-FMISO) Scans | k3 | 0 unitless |
Secondary
Overall Survival
Time frame: 3 years
Population: Participants who completed study treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 18F-FMISO PET/CT | Overall Survival | 40 % of participants alive |