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

NCT02016872 | Completed Results

• 2 other identifiers: 13-186U01CA157442-01A1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small-Cell-Lung Cancer (NSCLC)

Keywords

PET/CT; 18F-FMISO; tumor hypoxia; 13-186

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  3 years

Secondary Outcomes (1)

• Overall Survival

  3 years

Study Arms (1)

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.

Drug: 18F-FMISO; Other: PET/CT

Interventions

18F-FMISO DRUG

18F-FMISO PET/CT

PET/CT OTHER

18F-FMISO PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Women who are pregnant or breast-feeding
• Severe diabetes (fasting Blood Glucose \> 200 mg/dl)

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

• 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.

  PMID: 27822900 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

fluoromisonidazole

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Jacob Shin, MD
• Organization: Memorial Sloan Kettering Cancer Center

shinj2@mskcc.org

848-225-6436

Study Officials

• Jacob Shin, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: December 20, 2013
• Study Start: December 16, 2013
• Primary Completion: July 8, 2024
• Study Completion: July 8, 2024
• Last Updated: April 30, 2025
• Results First Posted: April 30, 2025

Record last verified: 2024-07

Locations

US (1)