Back to resultsIn-Room PET in Proton Radiation Therapy
Primary Purpose
Brain Tumor, Head and Neck Tumor, Skull Base Tumor
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PET scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Brain Tumor focused on measuring external beam proton radiotherapy, PET
Eligibility Criteria
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.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Participants 1-39
Arm Description
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.
Outcomes
Primary Outcome Measures
Effectiveness
Acquire PET/CT 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 PET/CT for in-room PET monitoring for proton radiation therapy quality assurance.
Secondary Outcome Measures
Optimize the in-room PET acquisition length
Reconstruct these list-mode PET data for different scan durations and optimize in-room PET acquisition length
Full Information
NCT ID
NCT01228448
First Posted
October 25, 2010
Last Updated
August 17, 2020
Sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT01228448
Brief Title
In-Room PET in Proton Radiation Therapy
Official Title
Pilot Study of In-Room PET in Proton Radiation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
January 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
For all participants, right after one regular treatment fraction, NeuroPET or NeuroPET II will be wheeled into the patient room. The patient bed will be moved directly into the scan position and a PET scan will be acquired in list-mode for 15 to 20 minutes followed by a CT scan for ~5 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor, Head and Neck Tumor, Skull Base Tumor
Keywords
external beam proton radiotherapy, PET
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Participants 1-39
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
PET scan
Intervention Description
In-Room PET scan
Primary Outcome Measure Information:
Title
Effectiveness
Description
Acquire PET/CT 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 PET/CT for in-room PET monitoring for proton radiation therapy quality assurance.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Optimize the in-room PET acquisition length
Description
Reconstruct these list-mode PET data for different scan durations and optimize in-room PET acquisition length
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen A. Shih, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
In-Room PET in Proton Radiation Therapy
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