- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01228448
In-Room PET in Proton Radiation Therapy
August 17, 2020 updated by: Helen A. Shih, MD, Massachusetts General Hospital
Pilot Study of In-Room PET in Proton Radiation Therapy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
In-Room PET scan
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effectiveness
Time Frame: 2 years
|
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.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Optimize the in-room PET acquisition length
Time Frame: 2 years
|
Reconstruct these list-mode PET data for different scan durations and optimize in-room PET acquisition length
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (ACTUAL)
January 1, 2020
Study Completion (ACTUAL)
January 1, 2020
Study Registration Dates
First Submitted
October 25, 2010
First Submitted That Met QC Criteria
October 25, 2010
First Posted (ESTIMATE)
October 26, 2010
Study Record Updates
Last Update Posted (ACTUAL)
August 18, 2020
Last Update Submitted That Met QC Criteria
August 17, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-241
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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