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Completed

NCT Number: NCT00713037

Hypoxia-positron Emission Tomography (PET) and Intensity Modulated Proton Therapy (IMPT) Dose Painting in Patients With Chordomas

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.

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Key information

Conditions

Chordoma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluoromisonidazole-PET/CT

Procedure

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

Other names: FMISO-PET/CT

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Hypoxia-PET and IMPT Dose Painting in Patients With Chordomas: A Pilot Study

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Jul 11, 2008
Registry last updated
Feb 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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