- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00713037
Hypoxia-positron Emission Tomography (PET) and Intensity Modulated Proton Therapy (IMPT) Dose Painting in Patients With Chordomas
February 2, 2017 updated by: Tom DeLaney, MD, Massachusetts General Hospital
Hypoxia-PET and IMPT Dose Painting in Patients With Chordomas: A Pilot Study
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 Overview
Detailed Description
- 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
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02214
- Massachusetts General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Skull base and spinal chordomas diagnosis based on pathology review by Department of Pathology at Massachusetts General Hospital
- Patient to be treated with proton or combined photon RT for primary CD or recurrent CD after surgery
- 18 years of age or older
- Karnofsky Score of 60% or greater
- Gross tumor mass larger than 1cm (maximal diameter on MRI)
Exclusion Criteria:
- Recurrences after RT
- Pregnancy
- Allergic reaction to FMISO injection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: (18F)-FMISO/CT
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).
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2 scans at different time intervals: 2 weeks before and 3 weeks after the participants first proton radiation treatment.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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To evaluate if FMISO-PET is a feasible approach for the visualization of hypoxia in skull base and spinal CD.
Time Frame: 2 years
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2 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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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
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2 years
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To evaluate and improve the precision of patients' positioning and image fusin using PET/CT for radiation treatment planning.
Time Frame: 2 years
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
July 9, 2008
First Submitted That Met QC Criteria
July 10, 2008
First Posted (Estimate)
July 11, 2008
Study Record Updates
Last Update Posted (Estimate)
February 3, 2017
Last Update Submitted That Met QC Criteria
February 2, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-162
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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