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Image Guided and Breathing Adapted Radiotherapy of Early Stage Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
visicoil gold marker 0.7 x 20 mm
Sponsored by
Gitte Fredberg Persson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Lung Cancer focused on measuring Lung Cancer, Stereotactic radiotherapy, Image guidance, breathing adaption, tumor motion, implanted marker

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Department of Radiation Oncology, Rigshospitalet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Implantation of gold marker

Arm Description

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

Outcomes

Primary Outcome Measures

motion of lung tumours
measured on 4DCT

Secondary Outcome Measures

toxicity of implanting gold coils into lung tumours
complication rate

Full Information

First Posted
May 28, 2009
Last Updated
February 23, 2021
Sponsor
Gitte Fredberg Persson
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1. Study Identification

Unique Protocol Identification Number
NCT00910546
Brief Title
Image Guided and Breathing Adapted Radiotherapy of Early Stage Lung Cancer
Official Title
Image Guided and Breathing Adapted Radiotherapy of Early Stage Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gitte Fredberg Persson

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Lung tumours move with respiration. This must be considered when designing margins for radiotherapy. This movement can be quantified by fluoroscopy or 4DCT. It is possible to identify a tumour middle position for planning. This middle position will vary from day to day and the extent of this variation is not fully known. The aim 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 margins for patients that take into account the full motion span throughout an entire course of SBRT Patients: 15 consecutive patients with inoperable low stage lung cancer or solitary metastases to the lung (1-2) referred for SBRT - 45 Gy/3 fractions. Methods: A gold coil will be implanted into the lung tumour one week before the planning. At planning and all treatment days supplementary 4DCT of thorax and two orthogonal fluoroscopy sessions will be performed. Tumour motion in the superior-inferior, medio-lateral and cranio-caudal direction will be measured and variation in amplitude and baseline for the tumour motion will be reported. Perspective: By examining the variation in tumour movement it will be possible design margins for SBRT, accounting for the full tumour motion span and minimizing the risk of geographical miss and thereby optimizing the chance for local tumour control.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung Cancer, Stereotactic radiotherapy, Image guidance, breathing adaption, tumor motion, implanted marker

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Implantation of gold marker
Arm Type
Experimental
Arm Description
CT guided implantation of gold marker into early stage lung tumors. Extra 4DCT scans and fluoroscopies during planning and the 3 fraction radiotherapy course.
Intervention Type
Device
Intervention Name(s)
visicoil gold marker 0.7 x 20 mm
Other Intervention Name(s)
Gold Ancor
Intervention Description
CT - guided implantation into lung tumors
Primary Outcome Measure Information:
Title
motion of lung tumours
Description
measured on 4DCT
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
toxicity of implanting gold coils into lung tumours
Description
complication rate
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: tumor > 6 cm no more than 2 tumours histological proven non small celled lung cancer signed Informed Consent Exclusion Criteria: Serious bleeding disorder Performance status 3-4 Tumour close to large vessels (judged by interventional radiologist)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gitte F Persson, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ditte E Nygaard, MSc
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Stine S Korreman, MSc PhD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lena Specht, MD DMSc
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Radiation Oncology, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Image Guided and Breathing Adapted Radiotherapy of Early Stage Lung Cancer

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