In-Room PET in Proton Radiation Therapy

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01228448

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

111

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Tumor Head and Neck Tumor Skull Base Tumor	Procedure: PET scan	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

59 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Pilot Study of In-Room PET in Proton Radiation Therapy

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Jan 1, 2020

Actual Study Completion Date :

Jan 1, 2020

Arms and Interventions

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.	Procedure: PET scan In-Room PET scan

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.

Procedure: PET scan

In-Room PET scan

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

Massachusetts General Hospital
National Cancer Institute (NCI)

Investigators

Principal Investigator: Helen A. Shih, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Helen A. Shih, MD, Attending Radiation Oncologist, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT01228448

Other Study ID Numbers:

10-241

First Posted:

Oct 26, 2010

Last Update Posted:

Aug 18, 2020

Last Verified:

Aug 1, 2020

Keywords provided by Helen A. Shih, MD, Attending Radiation Oncologist, Massachusetts General Hospital

external beam proton radiotherapy

PET

Additional relevant MeSH terms:

Head and Neck Neoplasms

Skull Base Neoplasms

Study Results

No Results Posted as of Aug 18, 2020