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

April 11, 2025 updated by: Memorial Sloan Kettering Cancer Center
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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. 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.
Drug: 18F-FMISO
Other: PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 days from baseline
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
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Jacob Shin, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2013

Primary Completion (Actual)

July 8, 2024

Study Completion (Actual)

July 8, 2024

Study Registration Dates

First Submitted

December 16, 2013

First Submitted That Met QC Criteria

December 16, 2013

First Posted (Estimated)

December 20, 2013

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 11, 2025

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-186
  • U01CA157442-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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