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Hypoxia-positron Emission Tomography (PET) and Intensity Modulated Proton Therapy (IMPT) Dose Painting in Patients With Chordomas

Primary Purpose

Chordoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fluoromisonidazole-PET/CT
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chordoma focused on measuring fluoromisonidazole, PET scan, Hypoxia-PET, IMPT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Skull base and spinal chordomas diagnosis based on pathology review by Department of Pathology at Massachusetts General Hospital
  • Patient to be treated with proton or combined photon RT for primary CD or recurrent CD after surgery
  • 18 years of age or older
  • Karnofsky Score of 60% or greater
  • Gross tumor mass larger than 1cm (maximal diameter on MRI)

Exclusion Criteria:

  • Recurrences after RT
  • Pregnancy
  • Allergic reaction to FMISO injection

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

(18F)-FMISO/CT

Arm Description

The study utilizes PET/CT scanning with (18F)-FMISO/CT in addition to standard used CT and MRI. Patients enrolled in this trial completed 2 PET/CT investigations, the first before proton radiation therapy and the second at a dose of approximately 30 Gy (24-36 Gy).

Outcomes

Primary Outcome Measures

To evaluate if FMISO-PET is a feasible approach for the visualization of hypoxia in skull base and spinal CD.

Secondary Outcome Measures

To investigate if using a Dose Painting/IMPT approach based on FMISO-PET/CT/MRI the irradiation dose can be escalated and the normal tissue be better spared in comparison to a IMPT approach based on anatomical imaging alone.
To evaluate and improve the precision of patients' positioning and image fusin using PET/CT for radiation treatment planning.

Full Information

First Posted
July 9, 2008
Last Updated
February 2, 2017
Sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00713037
Brief Title
Hypoxia-positron Emission Tomography (PET) and Intensity Modulated Proton Therapy (IMPT) Dose Painting in Patients With Chordomas
Official Title
Hypoxia-PET and IMPT Dose Painting in Patients With Chordomas: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Before radiation treatment is given to treat chordomas, CT and MRI scans are used to create a three dimensional picture of the tumor using x-rays. The CT and MRI scans are used to determine the size and location of the area that will receive radiation treatment. The purpose of this research study is to see if combining the images from the FMISO-PET scan and the CT and MRI scans in radiation treatment planning changes the size and location of the area that will receive radiation treatment when compared to planning the radiation treatment with CT and MRI scans alone.
Detailed Description
In this research study we are determining whether the positron emission tomography (PET) investigation performed with the investigational radioactive substance FMISO can show areas of tumor with lower oxygen levels. There is evidence that tumor with low oxygen levels are more resistant to radiation therapy. CT and MRI scans are not able to detect these oxygen levels in tumors. Participants will be asked to have the FMISO-PET/CT scan at 2 different times. It will be performed 2 weeks before and 3 weeks after the participants first proton radiation treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chordoma
Keywords
fluoromisonidazole, PET scan, Hypoxia-PET, IMPT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
(18F)-FMISO/CT
Arm Type
Experimental
Arm Description
The study utilizes PET/CT scanning with (18F)-FMISO/CT in addition to standard used CT and MRI. Patients enrolled in this trial completed 2 PET/CT investigations, the first before proton radiation therapy and the second at a dose of approximately 30 Gy (24-36 Gy).
Intervention Type
Procedure
Intervention Name(s)
Fluoromisonidazole-PET/CT
Other Intervention Name(s)
FMISO-PET/CT
Intervention Description
2 scans at different time intervals: 2 weeks before and 3 weeks after the participants first proton radiation treatment.
Primary Outcome Measure Information:
Title
To evaluate if FMISO-PET is a feasible approach for the visualization of hypoxia in skull base and spinal CD.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
To investigate if using a Dose Painting/IMPT approach based on FMISO-PET/CT/MRI the irradiation dose can be escalated and the normal tissue be better spared in comparison to a IMPT approach based on anatomical imaging alone.
Time Frame
2 years
Title
To evaluate and improve the precision of patients' positioning and image fusin using PET/CT for radiation treatment planning.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Skull base and spinal chordomas diagnosis based on pathology review by Department of Pathology at Massachusetts General Hospital Patient to be treated with proton or combined photon RT for primary CD or recurrent CD after surgery 18 years of age or older Karnofsky Score of 60% or greater Gross tumor mass larger than 1cm (maximal diameter on MRI) Exclusion Criteria: Recurrences after RT Pregnancy Allergic reaction to FMISO injection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas F. DeLaney, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02214
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Hypoxia-positron Emission Tomography (PET) and Intensity Modulated Proton Therapy (IMPT) Dose Painting in Patients With Chordomas

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