In-Room PET in Proton Radiation Therapy

Not Applicable

Completed

• Conditions: Head and Neck Tumor; Brain Tumor; Skull Base Tumor
• Interventions: Procedure: PET scan

• Registration Number: NCT01228448
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-25
• Study First Submitted QC: 2010-10-25
• Study First Posted: 2010-10-26
• Primary Completion: 2020-01
• Study Completion: 2020-01
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-17
• Last Update Posted: 2020-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants 1-39	PET scan	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.

Primary Outcome Measures

Name	Time	Method
Effectiveness	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.

Secondary Outcome Measures

Name	Time	Method
Optimize the in-room PET acquisition length	2 years	Reconstruct these list-mode PET data for different scan durations and optimize in-room PET acquisition length

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States