In-Room PET in Proton Radiation Therapy

NCT ID: NCT01228448

Last Updated: 2020-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2020-01-31

Brief Summary

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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

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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.

Conditions

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Brain Tumor Head and Neck Tumor Skull Base Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

PET scan

Intervention Type PROCEDURE

In-Room PET scan

Interventions

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PET scan

In-Room PET scan

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Helen A. Shih, MD

Attending Radiation Oncologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helen A. Shih, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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10-241

Identifier Type: -

Identifier Source: org_study_id

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