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Prognostic Value of Tumor Hypoxia, as Measured by 18F-FMISO Breath Hold PET/CT, in Non-Small-Cell-Lung Cancer (NSCLC) Patients

Primary Purpose

Non-Small-Cell-Lung Cancer (NSCLC)

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
18F-FMISO
PET/CT
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non-Small-Cell-Lung Cancer (NSCLC) focused on measuring PET/CT, 18F-FMISO, tumor hypoxia, 13-186

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-FMISO PET/CT

Arm Description

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.

Outcomes

Primary Outcome Measures

prognostic value of fluorine-18-labeled fluoro-misonidazole (18F-FMISO)
Breathing Hold and Free-Breathing (FB), dynamic 18F-FMISO PET images.
progression-free survival (PFS)

Secondary Outcome Measures

overall survival

Full Information

First Posted
December 16, 2013
Last Updated
January 18, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02016872
Brief Title
Prognostic Value of Tumor Hypoxia, as Measured by 18F-FMISO Breath Hold PET/CT, in Non-Small-Cell-Lung Cancer (NSCLC) Patients
Official Title
Prognostic Value of Tumor Hypoxia, as Measured by 18F-FMISO Breath Hold PET/CT, in Non-Small-Cell-Lung Cancer (NSCLC) Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 16, 2013 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small-Cell-Lung Cancer (NSCLC)
Keywords
PET/CT, 18F-FMISO, tumor hypoxia, 13-186

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18F-FMISO PET/CT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
18F-FMISO
Intervention Type
Other
Intervention Name(s)
PET/CT
Primary Outcome Measure Information:
Title
prognostic value of fluorine-18-labeled fluoro-misonidazole (18F-FMISO)
Description
Breathing Hold and Free-Breathing (FB), dynamic 18F-FMISO PET images.
Time Frame
2 years
Title
progression-free survival (PFS)
Time Frame
3 years
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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) 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Rimner, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27822900
Citation
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.
Results Reference
derived
Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

Prognostic Value of Tumor Hypoxia, as Measured by 18F-FMISO Breath Hold PET/CT, in Non-Small-Cell-Lung Cancer (NSCLC) Patients

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