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In-Room PET in Proton Radiation Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 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: October 22, 2014
Last verified: October 2014

October 25, 2010
October 22, 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 3 in-room PET/CT scans during proton radiation treatment. There are three groups.
  • Group 1: For Study Group 1 (thirty-one of the study participants), right after one regular treatment fraction, 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. For twenty-four of these participants, study imaging will be done on a day when they are treated with a single field; for seven of these participants, study imaging will be done on a day when they are treated with two fields.
  • Group 2: For Study Group 2 (five of the study participants), right after each of three regular treatment fractions, the patient bed will move directly into the scan position and a PET scan will be acquired in list-mode for 15 to 20 minutes. For participants in this group, study imaging will be done on days when they are treated with a single field.
  • Group 3: For Study Group 3 (three of the study participants), during each of three regular treatment fractions given on any day in the first, third and fifth weeks of treatment, the field with the lowest dose will be delivered first, then the patient bed will move directly into the scan position and a 20-min PET scan will be acquired.The participants will then be returned to the treatment position and other field(s) will be delivered with no additional scan after the treatment.
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 1-31
    PET Scan done right after one radiation treatment is complete and will take 15-20 minutes.
    Intervention: Procedure: PET scan
  • Experimental: Participants 32-36
    15-20 minute PET scan done after each of three doses of radiation given to the tumor.
    Intervention: Procedure: PET scan
  • Experimental: Participants 37-39
    15-20 minute PET scan will be done after the delivery of a single dose of radiation given on any day in the first, third or fifth week of treatment.
    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
39
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

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: Tarin Grillo 617-724-3661 tgrillo@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
October 2014

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