Hypoxia-Positron Emission Tomography (PET) and Intensity Modulated Proton Therapy (IMPT) Dose Painting in Patients With Chordomas - Full Text View

Sponsored by:	Massachusetts General Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00713037

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

MedlinePlus related topics: MRI Scans Nuclear Scans Radiation Therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Hypoxia-PET and IMPT Dose Painting in Patients With Chordomas: A Pilot Study

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 Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Intervention Details:

2 scans at different time intervals: 2 weeks before and 3 weeks after the participants first proton radiation treatment.

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

Contacts

Contact: Thomas F. DeLaney, MD	617-726-6876
Contact: Barbara Winrich	617-724-2334	bwinrich@partners.org

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02214

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator:

Thomas F. DeLaney, MD

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Massachusetts General Hospital ( Thomas F. DeLaney, MD )
Study ID Numbers:	07-162
Study First Received:	July 9, 2008
Last Updated:	February 9, 2009
ClinicalTrials.gov Identifier:	NCT00713037 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

fluoromisonidazole
PET scan
Hypoxia-PET
IMPT

Study placed in the following topic categories:

Signs and Symptoms
Radiation-Sensitizing Agents
Ro 07-0741
Neoplasms, Germ Cell and Embryonal

Signs and Symptoms, Respiratory
Chordoma
Anoxia

Additional relevant MeSH terms:

Signs and Symptoms
Neoplasms
Neoplasms by Histologic Type
Radiation-Sensitizing Agents
Ro 07-0741
Neoplasms, Germ Cell and Embryonal

Physiological Effects of Drugs
Signs and Symptoms, Respiratory
Chordoma
Pharmacologic Actions
Anoxia

ClinicalTrials.gov processed this record on May 07, 2009