Image Guided and Breathing Adapted Radiotherapy of Early Stage Lung Cancer

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Device: visicoil gold marker 0.7 x 20 mm

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Department of Radiation Oncology, Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Implantation of gold marker; 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; CT - guided implantation into lung tumors; Other Names: Gold Ancor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
motion of lung tumours	measured on 4DCT	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
toxicity of implanting gold coils into lung tumours	complication rate	1 year

Collaborators and Investigators

• Sponsor: Gitte Fredberg Persson
• Investigators: Principal Investigator: Gitte F Persson, MD, Rigshospitalet, Denmark; Study Chair: Ditte E Nygaard, MSc, Rigshospitalet, Denmark; Study Chair: Stine S Korreman, MSc PhD, Rigshospitalet, Denmark; Study Chair: Lena Specht, MD DMSc, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: May 28, 2009
• First Submitted That Met QC Criteria: May 28, 2009
• First Posted (Estimate): June 1, 2009

Study Record Updates

• Last Update Posted (Actual): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Lung Cancer; Image guidance; Stereotactic radiotherapy; tumor motion; breathing adaption; implanted marker
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: HPCRT002; H-B-2007-016 (Other Identifier: regional videnskabsetisk komite)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No