In-Room PET in Proton Radiation Therapy

Brain Tumor Clinical Trial

Official title:

Pilot Study of In-Room PET in Proton Radiation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01228448
• Other study ID #: 10-241
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Est. completion date: January 2020

Study information

• Verified date: August 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Tumor
• Head and Neck Neoplasms
• Head and Neck Tumor
• Skull Base Neoplasms
• Skull Base Tumor

Intervention

Procedure:
• PET scan
In-Room PET scan

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Secondary	Optimize the in-room PET acquisition length	Reconstruct these list-mode PET data for different scan durations and optimize in-room PET acquisition length	2 years