Hypoxia-positron Emission Tomography (PET) and Intensity Modulated Proton Therapy (IMPT) Dose Painting in Patients With Chordomas
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|ClinicalTrials.gov Identifier: NCT00713037|
Recruitment Status : Completed
First Posted : July 11, 2008
Last Update Posted : February 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chordoma||Procedure: Fluoromisonidazole-PET/CT||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hypoxia-PET and IMPT Dose Painting in Patients With Chordomas: A Pilot Study|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
The study utilizes PET/CT scanning with (18F)-FMISO/CT in addition to standard used CT and MRI. Patients enrolled in this trial completed 2 PET/CT investigations, the first before proton radiation therapy and the second at a dose of approximately 30 Gy (24-36 Gy).
2 scans at different time intervals: 2 weeks before and 3 weeks after the participants first proton radiation treatment.
Other Name: FMISO-PET/CT
- To evaluate if FMISO-PET is a feasible approach for the visualization of hypoxia in skull base and spinal CD. [ Time Frame: 2 years ]
- 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 ]
- To evaluate and improve the precision of patients' positioning and image fusin using PET/CT for radiation treatment planning. [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00713037
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02214|
|Principal Investigator:||Thomas F. DeLaney, MD||Massachusetts General Hospital|