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Image Guided and Breathing Adapted Radiotherapy of Early Stage Lung Cancer

Sponsor
Gitte Fredberg Persson (Other)
Overall Status
Completed
CT.gov ID
NCT00910546
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
25.9
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: visicoil gold marker 0.7 x 20 mm
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Image Guided and Breathing Adapted Radiotherapy of Early Stage Lung Cancer
Study Start Date :
Feb 1, 2009
Actual Primary Completion Date :
Apr 1, 2011
Actual Study Completion Date :
Apr 1, 2011

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. motion of lung tumours [3 weeks]

      measured on 4DCT

    Secondary Outcome Measures

    1. toxicity of implanting gold coils into lung tumours [1 year]

      complication rate

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Radiation Oncology, Rigshospitalet Copenhagen Denmark 2100

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gitte Fredberg Persson, MD PhD, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT00910546
    Other Study ID Numbers:
    • HPCRT002
    • H-B-2007-016
    First Posted:
    Jun 1, 2009
    Last Update Posted:
    Feb 26, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Gitte Fredberg Persson, MD PhD, Rigshospitalet, Denmark
    Lung Cancer
    Stereotactic radiotherapy
    Image guidance
    breathing adaption
    tumor motion
    implanted marker
    Additional relevant MeSH terms:
    Lung Neoplasms
    Respiratory Aspiration

    Study Results

    No Results Posted as of Feb 26, 2021