Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000726550
Ethics application status
Approved
Date submitted
10/06/2015
Date registered
15/07/2015
Date last updated
8/10/2019
Date data sharing statement initially provided
8/10/2019
Date results information initially provided
8/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Monitoring the motion of lung tumours with kilovoltage intrafraction monitoring
Scientific title
Feasibility of monitoring the motion of lung tumours with kilovoltage intrafraction monitoring
Secondary ID [1] 286892 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
KIM Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 295296 0
Condition category
Condition code
Cancer 295558 295558 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The KIM trial investigates the feasibility of providing a direct measure of lung tumour motion during radiotherapy treatment, using existing standard treatment equipment. It requires that radiographic markers are implanted into and around lung tumours via Endoscopic Bronchial Ultrasound (EBUS). The procedure has a duration of about 45 minutes. Then patients wait 2 weeks before continuing to routine radiotherapy simulation and planning. Treatment planning typically takes 2-3 weeks and then treatment will commence. The inserted markers are visualised and tracked using x-ray images, during the radiotherapy treatment sessions, once a week
Tracking will be performed using the Kilovoltage Intra-fraction Monitoring (KIM) software in an off-line retrospective manner.
KIM images will be collected 7 times during 30-33 fractions of radiotherapy, specifically at sessions 1, 6, 11, 16, 21, 26 and 30. Overall duration of the intervention is 6 weeks.
The intervention during radiotherapy treatment is administered as x-ray imaging.
Radiation Therapists administer the KIM imaging.
Intervention code [1] 292070 0
Treatment: Other
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295274 0
The successful visualisation of fiducials inserted into the tumour.
Timepoint [1] 295274 0
During treatment KIM images will be collected 7 times during 30-33 fractions of radiotherapy, specifically at sessions 1, 6, 11, 16, 21, 26 and 30.
Secondary outcome [1] 315252 0
Quantitative assessment of implanted marker relative positions, to determine position stability over time and any marker migration. This is evaluated by measuring distances in the XVI (x-ray system) software.
Timepoint [1] 315252 0
During treatment, specifically at sessions 1, 6, 11, 16, 21, 26 and 30.

Eligibility
Key inclusion criteria
1. Patient equal to or greater than 18 years of age
2. Patient with NSCLC or SCLC who are assessed as suitable for radical radiotherapy or chemo radiotherapy
3. Tumour greater than or equal to 5mm diameter
4. Tumour suitably positioned for fiducial insertion with linear EBUS
5. Patient does not have medical co-morbidities which preclude EBUS and fiducial insertion.
6. Centrally positioned primary and/or lymph nodes as identified by staging investigations such as CT scan of chest and/or PET scan.
7. Patients with curative intent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnant women and children under the age of 18;
2. Patients unable to give informed consent;
3. Patients with cardiac pacemakers and patients on anticoagulants.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
15/07/2015
Actual
15/04/2016
Date of last participant enrolment
Anticipated
15/07/2018
Actual
19/08/2016
Date of last data collection
Anticipated
28/12/2017
Actual
14/08/2017
Sample size
Target
24
Accrual to date
Final
2
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3904 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 9818 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 291444 0
Self funded/Unfunded
Name [1] 291444 0
Country [1] 291444 0
Primary sponsor type
Hospital
Name
Nepean and Blue Mountains Local Health District
Address
P O Box 63
Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 290119 0
None
Name [1] 290119 0
Address [1] 290119 0
Country [1] 290119 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292995 0
Nepean and Blue Mountains Local Health District
Ethics committee address [1] 292995 0
Ground Floor Court Building
Nepean Hospital
Penrith 2751
Ethics committee country [1] 292995 0
Australia
Date submitted for ethics approval [1] 292995 0
Approval date [1] 292995 0
14/05/2014
Ethics approval number [1] 292995 0
13/76 HREC/13/NEPEAN/138

Summary
Brief summary
This study is investigating the feasibility of providing a direct measure of lung tumour motion during radiotherapy treatment, using existing standard treatment equipment.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with lung cancer and are a Patient with non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC).

Study details
All patients in this study undergoing radiotherapy will have markers implanted into and around lung tumours using an airway ultrasound technique known as Endoscopic Bronchial Ultrasound (EBUS). The procedure has a duration of about 45 minutes. Then patients wait 2 weeks before continuing to routine radiotherapy simulation and planning. Treatment planning typically takes 2-3 weeks and then treatment will commence. The inserted markers are visualised and tracked using x-ray images, during the radiotherapy treatment sessions, once a week.
This study aims to validate a method to record real-time tumour motion due to respiration, during lung cancer radiotherapy treatment. Identifying the motion in real-time will help to implement treatments that can track tumours, resulting in safer and more effective treatments.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 58006 0
Dr Ben Ng
Address 58006 0
Nepean Hospital
PO Box 63
Penrith NSW2751
Country 58006 0
Australia
Phone 58006 0
+61 2 4734 2000
Fax 58006 0
+612 88247811
Email 58006 0
[email protected]
Contact person for public queries
Name 58007 0
Mrs Shamira Cross
Address 58007 0
Nepean Cancer Care Centre
Nepean Hospital
PO Box 63
Penrith NSW2751
Country 58007 0
Australia
Phone 58007 0
+61247343500
Fax 58007 0
+612 4734 1307
Email 58007 0
[email protected]
Contact person for scientific queries
Name 58008 0
Dr Roland Yeghiaian-Alvandi
Address 58008 0
Nepean Cancer Care Centre
Nepean Hospital
PO Box 63
Penrith NSW2751
Country 58008 0
Australia
Phone 58008 0
+61247343500
Fax 58008 0
+612 4734 1307
Email 58008 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.