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Pilot Study of In-Room PET in Proton Radiation Therapy


N/A
18 Years
N/A
Open (Enrolling)
Both
Brain Tumor, Head and Neck Tumor, Skull Base Tumor

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Trial Information

Pilot Study of In-Room PET in Proton Radiation Therapy


- Depending upon when the participant enrolls in the study, they will have anywhere from
1 to 4 in-room PET scans during proton radiation treatment. There are three groups.

- Group 1: A total of 24 participants in the study will have a PET scan right after their
first radiation treatment is completed. The scan will take 15-20 minutes. For 5 of
the first 19 participants, the PET scan will be performed three more times within a
week (Monday, Wednesday, Friday). For participants 20-24 the scan will be performed
three times in the 1st, 3rd and 5th weeks.

- Group 2: Three participants will have a 20 minute PET scan done after the first dose of
radiation given to the tumor.

- Group 3: Three participants will have a 5-20 minute PET scan done after the delivery of
the first dose of radiation, and a 15-20 minute PET scan will be done after the
delivery of the second dose of radiation.


Inclusion Criteria:



- Adult subjects with brain, head and neck, and skull base tumors receiving external
beam proton radiotherapy at the Francis H. Burr Proton Therapy Center at MGH

- Age 18 or over

- ECOG Performance status 0, 1 or 2

- Subjects must have internal CT markers implanted on the skull as part of their
radiation treatment planning

Exclusion Criteria:

- Uncontrolled intercurrent illness that, in the opinion of the investigator, would
limit the participant's compliance with study requirements.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Effectiveness

Outcome Description:

Acquire PET scan data in list-mode on patients undergoing external beam proton radiotherapy for brain and soft tissue tumors in head. Analyze these data to assess the effectiveness of using NeuroPET for in-room PET monitoring or proton radiation therapy quality assurance.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Helen A. Shih, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

10-241

NCT ID:

NCT01228448

Start Date:

October 2010

Completion Date:

Related Keywords:

  • Brain Tumor
  • Head and Neck Tumor
  • Skull Base Tumor
  • external beam proton radiotherapy
  • PET
  • Brain Neoplasms
  • Head and Neck Neoplasms
  • Skull Base Neoplasms

Name

Location

Massachusetts General Hospital Boston, Massachusetts  02114-2617