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Trial record 1 of 1 for:    NCT00713037
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Hypoxia-positron Emission Tomography (PET) and Intensity Modulated Proton Therapy (IMPT) Dose Painting in Patients With Chordomas

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Tom DeLaney, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00713037
First received: July 9, 2008
Last updated: May 4, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention
Chordoma
 Procedure: Fluoromisonidazole-PET/CT

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: June 2008
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00713037

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
Sponsors and Collaborators
Massachusetts General Hospital
National Cancer Institute (NCI)
Investigators
Principal Investigator: Thomas F. DeLaney, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Tom DeLaney, MD, Attending Radiation Oncologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00713037     History of Changes
Other Study ID Numbers: 07-162
Study First Received: July 9, 2008
Last Updated: May 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
fluoromisonidazole
PET scan
Hypoxia-PET
IMPT

Additional relevant MeSH terms:
Chordoma
Anoxia
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Signs and Symptoms, Respiratory
 Signs and Symptoms
Fluoromisonidazole
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013