NCT00713037

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 9, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2008

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

February 3, 2017

Status Verified

February 1, 2017

Enrollment Period

8 years

First QC Date

July 9, 2008

Last Update Submit

February 2, 2017

Conditions

Chordoma

Keywords

fluoromisonidazolePET scanHypoxia-PETIMPT

Outcome Measures

Primary Outcomes (1)

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

    2 years

Secondary Outcomes (2)

  • 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.

    2 years

  • To evaluate and improve the precision of patients' positioning and image fusin using PET/CT for radiation treatment planning.

    2 years

Study Arms (1)

(18F)-FMISO/CT

EXPERIMENTAL

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).

Procedure: Fluoromisonidazole-PET/CT

Interventions

Fluoromisonidazole-PET/CTPROCEDURE

2 scans at different time intervals: 2 weeks before and 3 weeks after the participants first proton radiation treatment.

Also known as: FMISO-PET/CT
(18F)-FMISO/CT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years of age or older
  • Karnofsky Score of 60% or greater
  • Gross tumor mass larger than 1cm (maximal diameter on MRI)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

Location

MeSH Terms

Conditions

Chordoma

Condition Hierarchy (Ancestors)

Neoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Thomas F. DeLaney, 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

July 9, 2008

First Posted

July 11, 2008

Study Start

June 1, 2008

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

February 3, 2017

Record last verified: 2017-02

Locations

US(1)