Non-Small-Cell-Lung Cancer (NSCLC)NCT02016872
Prognostic Value of Tumor Hypoxia, as Measured by 18F-FMISO Breath Hold PET/CT, in Non-Small-Cell-Lung Cancer (NSCLC) Patients
A study testing 18F-FMISO and PET/CT in people with Non-Small-Cell-Lung Cancer (NSCLC), run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell-Lung Cancer (NSCLC)
- What is being tested?
- 18F-FMISO and PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2013to 8 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Women who are pregnant or breast-feeding
- Severe diabetes (fasting Blood Glucose > 200 mg/dl)
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
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.
- Conditions
- Non-Small-Cell-Lung Cancer (NSCLC)
- Being tested
- 18F-FMISO, PET/CT
- Keywords
- PET/CT, 18F-FMISO, tumor hypoxia, 13-186
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FMISODrug
PET/CTOther
| Study group | Role | What they receive |
|---|---|---|
| 18F-FMISO PET/CT | Experimental | 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 dynamic baseline 18F-FMISO studies may precede the 18F-FDG study if the patient had a CT or PET/CT scan within the last 30 days that would permit the investigators to localize the tumor of interest during the 18F-FMISO study. In a group of 5 patients, the feasibility of simultaneous imaging of 18F-FMISO and 18F-FDG will be assessed. The patient will have an IV line placed for radiotracer injection and for venous blood sampling. All dynamic PET scans will be performed over one PET FOV centered at the lesion position. The 18F-FDG mid-treatment PET/CT scan will be performed over only one bed position. Receives: Drug: 18F-FMISO; Other: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days from baseline
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
Measured: 3 years
Secondary outcomes (1)
Overall Survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study start16 Dec 2013
- Primary completion8 Jul 2024
- Study completion8 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small-Cell-Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jacob Shin, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016872
- Sponsor's protocol ID
- 13-186
- Other IDs
- U01CA157442-01A1
- Status last verified
- Jul 2024
- First submitted
- 16 Dec 2013
- Last updated
- 30 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Grkovski M, Schwartz J, Rimner A, Schoder H, Carlin SD, Zanzonico PB, Humm JL, Nehmeh SA. Reproducibility of 18F-fluoromisonidazole intratumour distribution in non-small cell lung cancer. EJNMMI Res. 2016 Dec;6(1):79. doi: 10.1186/s13550-016-0210-y. Epub 2016 Nov 7.
PubMed 27822900
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Tumor Hypoxia, as Measured by 18F-FMISO Breath Hold PET/CT, in Non-Small-Cell-Lung Cancer (NSCLC) Patients
- ClinicalTrials.gov ID
- NCT02016872
- Acronym / sponsor ID
- 13-186
- Conditions
- Non-Small-Cell-Lung Cancer (NSCLC)
- Keywords
- PET/CT, 18F-FMISO, tumor hypoxia, 13-186
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 16 Dec 2013 (actual)
- Primary completion
- 8 Jul 2024 (actual)
- Study completion
- 8 Jul 2024 (actual)
- First posted
- 20 Dec 2013 (estimated)
- Results
- Posted 30 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-FMISO PET/CT | Experimental | Drug: 18F-FMISO, Other: PET/CTAll 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 dynamic baseline 18F-FMISO studies may precede the 18F-FDG study if the patient had a CT or PET/CT scan within the last 30 days that would permit the investigators to localize the tumor of interest during the 18F-FMISO study. In a group of 5 patients, the feasibility of simultaneous imaging of 18F-FMISO and 18F-FDG will be assessed. The patient will have an IV line placed for radiotracer injection and for venous blood sampling. All dynamic PET scans will be performed over one PET FOV centered at the lesion position. The 18F-FDG mid-treatment PET/CT scan will be performed over only one bed position. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Women who are pregnant or breast-feeding
- Severe diabetes (fasting Blood Glucose > 200 mg/dl)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FMISO | Drug | 18F-FMISO PET/CT |
| PET/CT | Other | 18F-FMISO PET/CT |
Primary outcome
The Difference Between Two Baseline Fluorine-18-labeled Fluoro-misonidazole (18F-FMISO) Scans
Time frame: 3 days from baseline
The difference between two baseline 18F-FMISO PET scans three days apart to assess the reproducibility.
Progression-free Survival (PFS)
Time frame: 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
1 secondary outcome
Overall Survival
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27822900Grkovski M, Schwartz J, Rimner A, Schoder H, Carlin SD, Zanzonico PB, Humm JL, Nehmeh SA. Reproducibility of 18F-fluoromisonidazole intratumour distribution in non-small cell lung cancer. EJNMMI Res. 2016 Dec;6(1):79. doi: 10.1186/s13550-016-0210-y. Epub 2016 Nov 7.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Shin, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-FMISO and PET/CT in people with Non-Small-Cell-Lung Cancer (NSCLC), run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Difference Between Two Baseline Fluorine-18-labeled Fluoro-misonidazole (18F-FMISO) Scans (time frame: 3 days from baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02016872, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.