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

Chordoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00713037
• Other study ID #: 07-162
• Status: Completed
• Phase: N/A
• First received: July 9, 2008
• Last updated: February 2, 2017
• Start date: June 2008
• Est. completion date: June 2016

Study information

• Verified date: February 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anoxia
• Chordoma

Intervention

Procedure:
• Fluoromisonidazole-PET/CT
2 scans at different time intervals: 2 weeks before and 3 weeks after the participants first proton radiation treatment.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate if FMISO-PET is a feasible approach for the visualization of hypoxia in skull base and spinal CD.		2 years
Secondary	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
Secondary	To evaluate and improve the precision of patients' positioning and image fusin using PET/CT for radiation treatment planning.		2 years