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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02016872
First received: December 16, 2013
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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 on taking advantage of the low oxygen supply to the tumor tissue and improve outcomes in lung cancer patients.


Condition Intervention
Non-Small-Cell-Lung Cancer (NSCLC)
Drug: 18F-FMISO
Other: PET/CT

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prognostic Value of Tumor Hypoxia, as Measured by 18F-FMISO Breath Hold PET/CT, in Non-Small-Cell-Lung Cancer (NSCLC) Patients

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • prognostic value of fluorine-18-labeled fluoro-misonidazole (18F-FMISO) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Breathing Hold and Free-Breathing (FB), dynamic 18F-FMISO PET images.

  • progression-free survival (PFS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2013
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 18F-FMISO PET scan will be repeated after the first one but before the start of therapy . The patient will have an IV line placed for radiotracer injection and for venous blood sampling. Both 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  • Primary tumor or nodal tumor must measure ≥ 2 cm on CT (hilar and mediastinal LN excluded)
  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02016872

Contacts
Contact: Andreas Rimner, MD 212-639-6025
Contact: Sadek Nehmeh, PhD 212-639-2175

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Andreas Rimner, MD    212-639-6025      
Contact: Sadek Nehmeh, PhD    212-639-2175      
Principal Investigator: Andreas Rimner, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Andreas Rimner, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02016872     History of Changes
Other Study ID Numbers: 13-186
Study First Received: December 16, 2013
Last Updated: June 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
PET/CT
18F-FMISO
tumor hypoxia
13-186

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Anoxia
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Fluoromisonidazole
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014