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Monitoring the motion of lung tumours with kilovoltage intrafraction monitoring

Feasibility of monitoring the motion of lung tumours with kilovoltage intrafraction monitoring

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000726550
Acronym
KIM Trial
Enrollment
2
Registered
2015-07-15
Start date
2016-04-15
Completion date
2016-08-19
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 treatm

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.

Sponsors

Nepean and Blue Mountains Local Health District
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026