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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Tom DeLaney, MD, Massachusetts General Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chordoma Procedure: Fluoromisonidazole-PET/CT Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Chordoma

Arms and Interventions
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Arm Intervention/treatment
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).
 Procedure: Fluoromisonidazole-PET/CT
2 scans at different time intervals: 2 weeks before and 3 weeks after the participants first proton radiation treatment.
Other Name: FMISO-PET/CT


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate if FMISO-PET is a feasible approach for the visualization of hypoxia in skull base and spinal CD. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. To evaluate and improve the precision of patients' positioning and image fusin using PET/CT for radiation treatment planning. [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
Sponsors and Collaborators
Massachusetts General Hospital
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Thomas F. DeLaney, MD Massachusetts General Hospital
More Information
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Responsible Party: Tom DeLaney, MD, Attending Radiation Oncologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00713037    
Other Study ID Numbers: 07-162
First Posted: July 11, 2008    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017
Keywords provided by Tom DeLaney, MD, Massachusetts General Hospital:
fluoromisonidazole
PET scan
Hypoxia-PET
IMPT
Additional relevant MeSH terms:
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Chordoma
Hypoxia
Signs and Symptoms, Respiratory
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms