Hypoxia-positron Emission Tomography (PET) and Intensity Modulated Proton Therapy (IMPT) Dose Painting in Patients With Chordomas
Before radiation treatment is given to treat chordomas, CT and MRI scans are used to create a three dimensional picture of the tumor using x-rays. The CT and MRI scans are used to determine the size and location of the area that will receive radiation treatment. The purpose of this research study is to see if combining the images from the FMISO-PET scan and the CT and MRI scans in radiation treatment planning changes the size and location of the area that will receive radiation treatment when compared to planning the radiation treatment with CT and MRI scans alone.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Hypoxia-PET and IMPT Dose Painting in Patients With Chordomas: A Pilot Study|
- To evaluate if FMISO-PET is a feasible approach for the visualization of hypoxia in skull base and spinal CD. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To investigate if using a Dose Painting/IMPT approach based on FMISO-PET/CT/MRI the irradiation dose can be escalated and the normal tissue be better spared in comparison to a IMPT approach based on anatomical imaging alone. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To evaluate and improve the precision of patients' positioning and image fusin using PET/CT for radiation treatment planning. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
- In this research study we are determining whether the positron emission tomography (PET) investigation performed with the investigational radioactive substance FMISO can show areas of tumor with lower oxygen levels. There is evidence that tumor with low oxygen levels are more resistant to radiation therapy. CT and MRI scans are not able to detect these oxygen levels in tumors.
- Participants will be asked to have the FMISO-PET/CT scan at 2 different times. It will be performed 2 weeks before and 3 weeks after the participants first proton radiation treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00713037
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02214|
|Principal Investigator:||Thomas F. DeLaney, MD||Massachusetts General Hospital|