In-Room PET in Proton Radiation Therapy

This study is currently recruiting participants.

Verified May 2013 by Massachusetts General Hospital

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Helen A. Shih, MD, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT01228448

First received: October 25, 2010

Last updated: May 2, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

October 25, 2010

Last Updated Date

May 2, 2013

Start Date ^ICMJE

October 2010

Estimated Primary Completion Date

April 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Effectiveness [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Acquire PET 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 NeuroPET for in-room PET monitoring or proton radiation therapy quality assurance.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01228448 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Optimize the in-room PET acquisition length [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Reconstruct these list-mode PET data for different scan durations and optimize in-room PET acquisition length

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

In-Room PET in Proton Radiation Therapy

Official Title ^ICMJE

Pilot Study of In-Room PET in Proton Radiation Therapy

Brief Summary

The investigational part of this study is using a mobile PET scanner called NeuroPET to take images of the participants tumor while they are receiving proton radiation treatment. This allows the participant to be treated and imaged in 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

Depending upon when the participant enrolls in the study, they will have anywhere from 1 to 4 in-room PET scans during proton radiation treatment. There are three groups.
Group 1: A total of 24 participants in the study will have a PET scan right after their first radiation treatment is completed. The scan will take 15-20 minutes. For 5 of the first 19 participants, the PET scan will be performed three more times within a week (Monday, Wednesday, Friday). For participants 20-24 the scan will be performed three times in the 1st, 3rd and 5th weeks.
Group 2: Three participants will have a 20 minute PET scan done after the first dose of radiation given to the tumor.
Group 3: Three participants will have a 5-20 minute PET scan done after the delivery of the first dose of radiation, and a 15-20 minute PET scan will be done after the delivery of the second dose of radiation.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Brain Tumor
Head and Neck Tumor
Skull Base Tumor

Intervention ^ICMJE

Procedure: PET scan

In-Room PET scan

Study Arm (s)

Experimental: Participants 1-24
PET Scan done right after the first radiation treatment is complete and will take 15-20 minutes. The scan will then be performed three more times.

Intervention: Procedure: PET scan
Experimental: Participants 25-27
20 minute PET scan done after the first dose of radiation given to the tumor.

Intervention: Procedure: PET scan
Experimental: Participants 28-30
5-10 minute PET scan will be done after the delivery of the first dose of radiation, and a 15-20 minute PET scan will be done after the delivery of the second dose of radiation.

Intervention: Procedure: PET scan

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

April 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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
Subjects must have internal CT markers implanted on the skull as part of their radiation treatment planning

Exclusion Criteria:

Uncontrolled intercurrent illness that, in the opinion of the investigator, would limit the participant's compliance with study requirements.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Helen A. Shih, MD

617-643-7250

hshih@partners.org

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01228448

Other Study ID Numbers ^ICMJE

10-241

Has Data Monitoring Committee

Yes

Responsible Party

Helen A. Shih, MD, Massachusetts General Hospital

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Helen A. Shih, MD

Massachusetts General Hospital

Information Provided By

Massachusetts General Hospital

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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