In-Room PET in Proton Radiation Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Helen A. Shih, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01228448
First received: October 25, 2010
Last updated: April 11, 2014
Last verified: April 2014

October 25, 2010
April 11, 2014
October 2010
December 2014   (final data collection date for primary outcome measure)
Effectiveness [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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.
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.
Complete list of historical versions of study NCT01228448 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
In-Room PET in Proton Radiation Therapy
Pilot Study of In-Room PET in Proton Radiation Therapy

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.

  • Depending upon when the participant enrolls in the study, they will have anywhere from 1 to 4 in-room PET/CT scans during proton radiation treatment. There are three groups.
  • Group 1: A total of 24 participants in the study will have a PET/CT 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/CT 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/CT scan done after the first dose of radiation given to the tumor.
  • Group 3: Three participants will have a 5-20 minute PET/CT scan done after the delivery of the first dose of radiation, and a 15-20 minute PET/CT scan will be done after the delivery of the second dose of radiation.
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Brain Tumor
  • Head and Neck Tumor
  • Skull Base Tumor
Procedure: PET scan
In-Room PET scan
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Not Provided
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Barbara Winrich, MA 617-724-2334 bwinrich@partners.org
United States
 
NCT01228448
10-241
Yes
Helen A. Shih, MD, Massachusetts General Hospital
Massachusetts General Hospital
National Cancer Institute (NCI)
Principal Investigator: Helen A. Shih, MD Massachusetts General Hospital
Massachusetts General Hospital
April 2014

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