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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
  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: 39
Study Start Date: October 2010
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Participants 1-31
PET Scan done right after one radiation treatment is complete and will take 15-20 minutes.
Procedure: PET scan
In-Room PET scan
Experimental: Participants 32-36
15-20 minute PET scan done after each of three doses of radiation given to the tumor.
Procedure: PET scan
In-Room 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.
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 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.
  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

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: Tarin Grillo 617-724-3661 tgrillo@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: October 22, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 25, 2014