Trial Outcomes & Findings for Prognostic Value of Tumor Hypoxia, as Measured by 18F-FMISO Breath Hold PET/CT, in Non-Small-Cell-Lung Cancer (NSCLC) Patients (NCT NCT02016872)
NCT ID: NCT02016872
Last Updated: 2025-04-30
Results Overview
The difference between two baseline 18F-FMISO PET scans three days apart to assess the reproducibility.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
3 days from baseline
Results posted on
2025-04-30
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
|
Overall Study
Death Progression
|
2
|
|
Overall Study
No FMISO scan
|
1
|
|
Overall Study
Ineligible
|
2
|
Baseline Characteristics
Prognostic Value of Tumor Hypoxia, as Measured by 18F-FMISO Breath Hold PET/CT, in Non-Small-Cell-Lung Cancer (NSCLC) Patients
Baseline characteristics by cohort
| Measure |
18F-FMISO PET/CT
n=25 Participants
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.
|
|---|---|
|
Age, Continuous
|
64 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 3 days from baselinePopulation: Participants who completed study treatment
The difference between two baseline 18F-FMISO PET scans three days apart to assess the reproducibility.
Outcome measures
| Measure |
18F-FMISO PET/CT
n=10 Participants
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 Difference Between Two Baseline Fluorine-18-labeled Fluoro-misonidazole (18F-FMISO) Scans
k1
|
0 unitless
Interval -0.119 to 0.1203
|
|
The Difference Between Two Baseline Fluorine-18-labeled Fluoro-misonidazole (18F-FMISO) Scans
k3
|
0 unitless
Interval -0.0159 to 0.0146
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: Participants who completed study treatment
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
Outcome measures
| Measure |
18F-FMISO PET/CT
n=10 Participants
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.
|
|---|---|
|
Progression-free Survival (PFS)
|
58.3 % of pts with progression free survival
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Participants who completed study treatment
Outcome measures
| Measure |
18F-FMISO PET/CT
n=10 Participants
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.
|
|---|---|
|
Overall Survival
|
40 % of participants alive
|
Adverse Events
18F-FMISO PET/CT
Serious events: 2 serious events
Other events: 2 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
18F-FMISO PET/CT
n=25 participants at risk
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.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
4.0%
1/25 • 3 years
|
|
General disorders
Non-cardiac chest pain secondary to migration of esophageal stent
|
4.0%
1/25 • 3 years
|
Other adverse events
| Measure |
18F-FMISO PET/CT
n=25 participants at risk
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.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
4.0%
1/25 • 3 years
|
|
General disorders
Non-cardiac chest pain secondary to migration of esophageal stent
|
4.0%
1/25 • 3 years
|
Additional Information
Dr. Jacob Shin, MD
Memorial Sloan Kettering Cancer Center
Phone: 848-225-6436
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place