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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00713037
Enrollment
20
Registered
2008-07-11
Start date
2008-06-30
Completion date
2016-06-30
Last updated
2017-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chordoma

Keywords

fluoromisonidazole, PET scan, Hypoxia-PET, IMPT

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.

Interventions

PROCEDUREFluoromisonidazole-PET/CT

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

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026