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

NCT01617980 | Terminated

• 1 other identifier: HIL-DOT-MOBI
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer

Keywords

Hypoxia imaging; FMISO-PET; functional MRI; Intensity modulated radiation therapy

Outcome Measures

Primary Outcomes (1)

• Standard uptake value (SUV) of 18F-FMISO and k1 and k2 parameters

  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).

  3 months

Secondary Outcomes (3)

• Local recurrence rate

  2 years

• Progression free survival

  2 years

• Overall survival

  2 years

Study Arms (1)

Multimodal hypoxia imaging

OTHER

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

Other: Multimodal hypoxia imaging

Interventions

Multimodal hypoxia imaging OTHER

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

Multimodal hypoxia imaging

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• German Cancer Research Center: lead

Study Sites (1)

German Cancer Research Center

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Related Publications (1)

• Askoxylakis V, Dinkel J, Eichinger M, Stieltjes B, Sommer G, Strauss LG, Dimitrakopoulou-Strauss A, Kopp-Schneider A, Haberkorn U, Huber PE, Bischof M, Debus J, Thieke C. Multimodal hypoxia imaging and intensity modulated radiation therapy for unresectable non-small-cell lung cancer: the HIL trial. Radiat Oncol. 2012 Sep 14;7:157. doi: 10.1186/1748-717X-7-157.

  PMID: 22974533 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Officials

• Jürgen Debus, Professor

  University Clinic Heidelberg and German Cancer Research Center

  PRINCIPAL INVESTIGATOR

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: April 10, 2012
• First Posted: June 13, 2012
• Study Start: April 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 17, 2014

Record last verified: 2014-03

Locations

DE (1)