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
  Purpose

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 Intervention
Brain Tumor
Head and Neck Tumor
Skull Base Tumor
Procedure: PET scan

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pilot Study of In-Room PET in Proton Radiation Therapy

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 30
Study Start Date: October 2010
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: PET scan
In-Room PET scan
Experimental: Participants 25-27
20 minute PET scan done after the first dose of radiation given to the tumor.
Procedure: PET scan
In-Room 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.
Procedure: PET scan
In-Room PET scan

Detailed Description:
  • 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01228448

Contacts
Contact: Barbara Winrich, MA 617-724-2334 bwinrich@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Helen A. Shih, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Helen A. Shih, MD, Attending Radiation Oncologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01228448     History of Changes
Other Study ID Numbers: 10-241
Study First Received: October 25, 2010
Last Updated: April 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
external beam proton radiotherapy
PET

Additional relevant MeSH terms:
Skull Base Neoplasms
Skull Neoplasms
Brain Neoplasms
Head and Neck Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Bone Neoplasms
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 28, 2014