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Multimodal Hypoxia Imaging and Intensity Modulated Radiotherapy for Inoperable Non-small-cell Lung Cancer (HIL)

This study is currently recruiting participants.
Verified June 2012 by German Cancer Research Center
Sponsor:
Information provided by (Responsible Party):
German Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01617980
First received: April 10, 2012
Last updated: June 11, 2012
Last verified: June 2012
History of Changes
  Purpose

Radiotherapy, preferably combined with chemotherapy, is the treatment standard for locally advanced, unresectable non-small cell lung cancer (NSCLC). The tumor response to different therapy protocols is variable, with hypoxia known to be a major factor that negatively influences treatment effectiveness. Visualisation of tumor hypoxia prior to the use of modern radiation therapy strategies, such as intensity modulated radiation therapy (IMRT), might allow higher dose applications to the target volume, leading to improvement of therapy outcome. 18F-fluoromisonidazole dynamic positron emission tomography and computed tomography (18F-FMISO dPET-CT) and functional magnetic resonance imaging (functional MRI) are attractive strategies for imaging tumor hypoxia. The HIL trial is a single centre pilot study combining multimodal hypoxia imaging with 18F-FMISO dPET-CT and functional MRI and intensity modulated radiation therapy (IMRT) in patients with inoperable stage III NSCLC. 15 patients are recruited in the study. All patients undergo serial 18F-FMISO dPET-CT and functional MRI before treatment, at week 5 of radiotherapy and 6 weeks post treatment. Radiation therapy is performed as inversely planned IMRT after four dimensional computed tomography (4D-CT) based target volume definition. Hypoxia imaging is not included in target volume definition or IMRT dose prescription.

Objectives of the trial are to characterize the correlation of 18F-FMISO dPET-CT and functional MRI for tumor hypoxia imaging in NSCLC and evaluate possible effects of radiation therapy on tumor re-oxygenation. Further objectives include the generation of data regarding the prognostic value of 18F-FMISO dPET-CT and functional MRI for locoregional control, progression free survival and overall survival of NSCLC treated with IMRT, which will form the basis for larger clinical trials focusing on possible interactions between tumor oxygenation and radiation outcome.


Condition Intervention
Non-small Cell Lung Cancer
 Other: Multimodal hypoxia imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by German Cancer Research Center:

Primary Outcome Measures:
  • Standard uptake value (SUV) of 18F-FMISO and k1 and k2 parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Primary aim of the study is to assess the correlation between measurements of the standard uptake value (SUV) of 18F-FMISO, as well as measurements of the parameters k1 and k2, which reflect the influx and efflux of FMISO into and out of the cells with functional MRI parameters, such as diffusion coefficients in matched regions of interest in patients with stage III NSCLC treated with intensity modulated radiation therapy (IMRT).


Secondary Outcome Measures:
  • Local recurrence rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Assessement of the prognostic value of serial 18F-FMISO dPET-CT and functional MRI for 1-year and 2-year local recurrence rate.

  • Progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Assessement of the prognostic value of serial 18F-FMISO dPET-CT and functional MRI for 1-year and 2-year progression free survival.

  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Assessement of the prognostic value of serial 18F-FMISO dPET-CT and functional MRI for overall survival.


Estimated Enrollment: 15
Study Start Date: April 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Multimodal hypoxia imaging
    Patients with inoperable, stage III non-small cell lung cancer receive serial 18F-FMISO dPET-CT and functional MRI investigations prior, during and post radiation treatment
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented inoperable, histologically confirmed NSCLC stage III
  • Sufficient remaining lung function (FeV1>1.5 l/s or at least 50 % of the respective individual norm value)
  • Karnofsky Performance Score of 70 % or higher.
  • Patients > 18 years of age.
  • Adequate haematological function (wbc>3000 x 10^3 /ml, thc >100 ×10^6 /ml, Hb>10 g/dl)
  • Adequate hepatic and renal function
  • Written informed consent

Exclusion Criteria:

  • Patient refusal
  • Severe concurrent systemic disease
  • Claustrophobia
  • Cardiac pacemaker
  • Other malignancies
  • Hypersensitivity to x-ray contrast medium or 18F-FMISO
  • Severe renal or hepatic insufficiency
  • NSCLC stage I, II or IV
  • Pregnancy or lactation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01617980

Contacts
Contact: Christian Thieke, Dr. med. Dr. rer. nat. 0049 (0) 6221 422544 c.thieke@dkfz.de
Contact: Vasileios Askoxylakis, Dr. med. 0049 (0) 6221 422616 v.askoxylakis@dkfz.de

Locations
Germany
German Cancer Research Center Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Christian Thieke, Dr. med. Dr. rer. nat.     0049 (0) 6221 422544     c.thieke@dkfz.de    
Contact: Vasileios Askoxylakis, Dr. med.     0049 (0) 6221 422616     v.askoxylakis@dkfz.de    
Principal Investigator: Jürgen Debus, Professor            
Sponsors and Collaborators
German Cancer Research Center
Investigators
Principal Investigator: Jürgen Debus, Professor University Clinic Heidelberg and German Cancer Research Center
  More Information

No publications provided by German Cancer Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: German Cancer Research Center
ClinicalTrials.gov Identifier: NCT01617980     History of Changes
Other Study ID Numbers: HIL-DOT-MOBI
Study First Received: April 10, 2012
Last Updated: June 11, 2012
Health Authority: Germany: Ethics Committee of the University of Heidelberg

Keywords provided by German Cancer Research Center:
Hypoxia imaging
FMISO-PET
functional MRI
Intensity modulated radiation therapy

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013