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


N/A
18 Years
N/A
Open (Enrolling)
Both
Chordoma

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Trial Information

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


- 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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Thomas F. DeLaney, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

07-162

NCT ID:

NCT00713037

Start Date:

June 2008

Completion Date:

July 2014

Related Keywords:

  • Chordoma
  • fluoromisonidazole
  • PET scan
  • Hypoxia-PET
  • IMPT
  • Chordoma
  • Anoxia

Name

Location
Massachusetts General Hospital Boston, Massachusetts  02114-2617