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Completed

NCT Number: NCT01228448

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.

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Key information

Conditions

Brain Tumor Bone Diseases Bone Neoplasms Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Head and Neck Neoplasms Head and Neck Tumor Musculoskeletal Diseases Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Skull Base Neoplasms Skull Base Tumor Skull Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

For all participants, right after one regular treatment fraction, NeuroPET or NeuroPET II will be wheeled into the patient room. 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 followed by a CT scan for ~5 minutes. After undergoing their first PET scan, participants will have the option to undergo 1-2 additional scans throughout radiation treatment in the same manner as the first scan.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PET Scan

Procedure

In-Room PET scan

Primary outcomes

  1. Effectiveness

    Time frame: 2 years

    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 outcomes

  1. Optimize the in-room PET acquisition length

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Pilot Study of In-Room PET in Proton Radiation Therapy

Important dates

Study start
2010
Primary completion
2020
Study completion
2020
First posted
Oct 26, 2010
Registry last updated
Aug 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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