Clinical Trial - NCT01228448

In-Room PET in Proton Radiation Therapy

Recruiting

Sponsor: Massachusetts General Hospital

Collaborators: National Cancer Institute (NCI)

Information provided by (Responsible party): Principal Investigator Massachusetts General Hospital Helen A. Shih, MD Attending Radiation Oncologist

ClinicalTrials.gov Identifier: NCT01228448

Protocol Info

Short Description: Pilot Study of In-room PET in Proton RT
Long Description: Pilot Study of In-room PET in Proton Radiation Therapy
MGH Status: Closed
Sponsor: DF/HCC
Disease Program: Proton

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




Purpose

The investigational part of this study is using a mobile PET/CT scanner to take images of the participants tumor immediately after they are treated with proton radiation. This allows the participant to be treated and imaged on the same bed. The information obtained may improve the accuracy of treatment and may help to minimize the dose delivered unnecessarily to healthy tissue.
Condition Title Intervention Phase
Brain Tumor Head and Neck Tumor Skull Base Tumor PET scan N/A
Study Type Interventional
Official Title Pilot Study of In-Room PET in Proton Radiation Therapy

Primary Outcome Measures

Effectiveness [Time Frame: 2 years] [Designated as safety issue: ]


Secondary Outcome Measures

Optimize the in-room PET acquisition length [Time Frame: 2 years] [Designated as safety issue: ]

Estimated Enrollment: 60
Study Start Date: October 2010
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2020
Arms Assigned Interventions

Experimental:Participants 1-39

PET Scan done right after one radiation treatment is complete and will take 15-20 minutes. After undergoing their first PET scan, participants will have the option to undergo 1-2 additional scans throughout radiation treatment in the same manner as the first scan.
Procedure:PET scan
In-Room PET scan

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01228448

Locations

  • United States, Massachusetts
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

National Cancer Institute (NCI)

More Information

No publications provided

Responsible Party: Principal Investigator Massachusetts General Hospital Helen A. Shih, MD Attending Radiation Oncologist
ClinicalTrials.gov Identifier: NCT01228448
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Massachusetts General Hospital:

external beam proton radiotherapy

PET

Additional relevant MeSH terms:

Head and Neck Neoplasms

Skull Base Neoplasms

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on April 09, 2020