In-Room PET in Proton Radiation Therapy

NCT01228448 | Completed DMC

• 1 other identifier: 10-241
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Tumor; Head and Neck Tumor; Skull Base Tumor

Keywords

external beam proton radiotherapy; PET

Outcome Measures

Primary Outcomes (1)

• Effectiveness

  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.

  2 years

Secondary Outcomes (1)

• Optimize the in-room PET acquisition length

  2 years

Study Arms (1)

Participants 1-39

EXPERIMENTAL

PET Scan done right after one radiation treatment is complete and will take 15-20 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.

Procedure: PET scan

Interventions

PET scan PROCEDURE

In-Room PET scan

Participants 1-39

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Uncontrolled intercurrent illness that, in the opinion of the investigator, would limit the participant's compliance with study requirements.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Head and Neck Neoplasms; Skull Base Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skull Neoplasms; Bone Neoplasms; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Helen A. Shih, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Radiation Oncologist

Study Record Dates

• First Submitted: October 25, 2010
• First Posted: October 26, 2010
• Study Start: October 1, 2010
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: August 18, 2020

Record last verified: 2020-08

Locations

US (1)