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

Not Applicable

Completed

• Conditions: Chordoma
• Interventions: Procedure: Fluoromisonidazole-PET/CT

• Registration Number: NCT00713037
• Lead Sponsor: Massachusetts General Hospital

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.

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 Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-09
• Study First Submitted QC: 2008-07-10
• Study First Posted: 2008-07-11
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
(18F)-FMISO/CT	Fluoromisonidazole-PET/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).

Primary Outcome Measures

Name	Time	Method
To evaluate if FMISO-PET is a feasible approach for the visualization of hypoxia in skull base and spinal CD.	2 years

Secondary Outcome Measures

Name	Time	Method
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.	2 years
To evaluate and improve the precision of patients' positioning and image fusin using PET/CT for radiation treatment planning.	2 years

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States