NCT00358007

Brief Summary

To evaluate the use of cone beam computed tomography in treating head and neck to hopefully reduce side effects

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 28, 2006

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
4 years until next milestone

Results Posted

Study results publicly available

August 21, 2014

Completed
Last Updated

May 4, 2025

Status Verified

May 1, 2025

Enrollment Period

11 months

First QC Date

July 27, 2006

Results QC Date

June 12, 2014

Last Update Submit

May 1, 2025

Conditions

Keywords

Kilovoltage ImagingCone-beam CTCBCTradiation therapyhead and neck neoplasms

Outcome Measures

Primary Outcomes (2)

  • Average Interfraction Shift of Patients Undergoing Radiotherapy

    Determine the magnitude of the systematic error of patient positioning as determined by cone beam CT (CBCT) and the desired placement based on the treatment planning CT scan. Every day, prior to radiation treatment, a CBCT will be performed. The CBCT images will be compared to the radiation therapy planning CT image just taken.

    Daily prior to radiation

  • Average Residual Error Motion of Patients Undergoing Radiotherapy

    To determine the magnitude of random variance (random error) in radiotherapy treatment of head and neck neoplasms

    Daily after each radiotherapy treatment

Study Arms (1)

Cone Beam CT

EXPERIMENTAL
Device: PTV Reduction

Interventions

The margin around the area to be treated with radiation is decreased due the image guidance of the cone beam CT

Cone Beam CT

Eligibility Criteria

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

You may qualify if:

  • any patient receiving radiation therapy for a head and neck tumor assigned to the new Elekta Synergy Linare Accelerator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

  • Den RB, Doemer A, Kubicek G, Bednarz G, Galvin JM, Keane WM, Xiao Y, Machtay M. Daily image guidance with cone-beam computed tomography for head-and-neck cancer intensity-modulated radiotherapy: a prospective study. Int J Radiat Oncol Biol Phys. 2010 Apr;76(5):1353-9. doi: 10.1016/j.ijrobp.2009.03.059. Epub 2009 Jun 18.

Related Links

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Results Point of Contact

Title
Pramila Rani Anne, MD
Organization
Thomas Jefferson University

Study Officials

  • Pramila Rani Anne, MD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2006

First Posted

July 28, 2006

Study Start

March 1, 2007

Primary Completion

February 1, 2008

Study Completion

September 1, 2010

Last Updated

May 4, 2025

Results First Posted

August 21, 2014

Record last verified: 2025-05

Locations