NCT00910546

Brief Summary

The purpose of this study is to quantify the variation in tumour middle position during a course of stereotactic body radiotherapy (SBRT), and thereby be able to design radiotherapy margins that takes into account the full motion span throughout an entire course of SBRT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started Feb 2009

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

February 26, 2021

Status Verified

February 1, 2021

Enrollment Period

2.2 years

First QC Date

May 28, 2009

Last Update Submit

February 23, 2021

Conditions

Lung Cancer

Keywords

Lung CancerStereotactic radiotherapyImage guidancebreathing adaptiontumor motionimplanted marker

Outcome Measures

Primary Outcomes (1)

  • motion of lung tumours

    measured on 4DCT

    3 weeks

Secondary Outcomes (1)

  • toxicity of implanting gold coils into lung tumours

    1 year

Study Arms (1)

Implantation of gold marker

EXPERIMENTAL

CT guided implantation of gold marker into early stage lung tumors. Extra 4DCT scans and fluoroscopies during planning and the 3 fraction radiotherapy course.

Device: visicoil gold marker 0.7 x 20 mm

Interventions

visicoil gold marker 0.7 x 20 mmDEVICE

CT - guided implantation into lung tumors

Also known as: Gold Ancor
Implantation of gold marker

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • tumor \> 6 cm
  • no more than 2 tumours
  • histological proven non small celled lung cancer
  • signed Informed Consent

You may not qualify if:

  • Serious bleeding disorder
  • Performance status 3-4
  • Tumour close to large vessels (judged by interventional radiologist)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiation Oncology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Gitte F Persson, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

  • Ditte E Nygaard, MSc

    Rigshospitalet, Denmark

    STUDY CHAIR

  • Stine S Korreman, MSc PhD

    Rigshospitalet, Denmark

    STUDY CHAIR

  • Lena Specht, MD DMSc

    Rigshospitalet, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

May 28, 2009

First Posted

June 1, 2009

Study Start

February 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

February 26, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)