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

NCT ID: NCT00713037

Last Updated: 2017-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2016-06-30

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.

Conditions

Chordoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

(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).

Group Type: EXPERIMENTAL

Fluoromisonidazole-PET/CT

Intervention Type: PROCEDURE

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

Interventions

Fluoromisonidazole-PET/CT

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

Intervention Type: PROCEDURE

Other Intervention Names

FMISO-PET/CT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Responsible Party

Tom DeLaney, MD

Attending Radiation Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas F. DeLaney, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

07-162

Identifier Type: -

Identifier Source: org_study_id