Clinical trial NCT00713037: Hypoxia-positron Emission Tomography (PET) and Intensity Modulated Proton Therapy (IMPT) Dose Painting in Patients With Chordomas
Official title: Hypoxia-PET and IMPT Dose Painting in Patients With Chordomas: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chordoma
Keywords: fluoromisonidazole
PET scan
Hypoxia-PET
IMPT
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-07-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: To evaluate if FMISO-PET is a feasible approach for the visualization of hypoxia in skull base and spinal CD.
timeFrame: 2 years
Secondary outcomes:
measure: 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.
timeFrame: 2 years
measure: To evaluate and improve the precision of patients' positioning and image fusin using PET/CT for radiation treatment planning.
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Thomas F. DeLaney, MD
role: PRINCIPAL_INVESTIGATOR
References: