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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04086082




Registration number
NCT04086082
Ethics application status
Date submitted
6/05/2019
Date registered
11/09/2019

Titles & IDs
Public title
Markerless Image Guidance Using Intrafraction Kilovoltage X-ray Imaging
Scientific title
MAGIK: Using Implanted Markers to Determine the Feasibility of Markerless Image Guidance Using Intrafraction Kilovoltage X-ray Imaging: A Phase I Interventional Study of Lung Cancer Radiotherapy
Secondary ID [1] 0 0
MAGIK V1.0
Universal Trial Number (UTN)
Trial acronym
MAGIK
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Markerless Image Guidance

Experimental: Markerless Image Guidance Arm - Single arm trial using implanted markers to determine the feasibility of Markerless Image Guidance using Intrafraction Kilovoltage X-ray Imaging


Treatment: Devices: Markerless Image Guidance
Single arm trial using implanted markers to determine the feasibility of Markerless Image Guidance using Intrafraction Kilovoltage X-ray Imaging
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Markerless Tumour Tracking is feasible for motion-adaptive lung cancer radiotherapy
Timepoint [1] 0 0
2 years

Eligibility
Key inclusion criteria
* Is willing to comply with all trial procedures and intends to provide written Informed Consent for participation in this trial.
* Patients undergoing external beam radiotherapy.
* Histologically proven Stage I NSCLC or oligometastatic lung metastases (3 or less).
* MRI/4D-CT prior to insertion of fiducial markers.
* Patient must be able to have fiducial markers placed in the lung (if on anticoagulants, must be cleared by LMO or cardiologist).
* ECOG performance status 0-2.
* A maximum of three metastases to the lung from any non-haematological malignancy. Multiple metastases will be treated separately.
* 1 cm = Tumour diameter in any dimension = = 5 cm.
* The distance between the tumour centroid and the top end of the diaphragm is <=10 cm.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patient has low respiratory performance as evaluated by the physicians.
* Previous high-dose thoracic radiotherapy.
* Less than one fiducial marker implanted in the lung.
* Fiducial markers are too far from the tumour centroid (>9 cm).
* Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. Hormonal manipulation agents are allowable (e.g. aromatase inhibitors, selective oestrogen receptor modulators, and gonadotropin releasing hormone receptor modulators).
* Targeted agents (such as sunitinib, bevacizumab and tarceva) within 7 days of commencement of treatment, or concurrently with treatment.
* Women who are pregnant or lactating.
* Unwilling or unable to complete quality of life questionnaires.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2028
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Keall, PhD
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Coordinator
Address 0 0
Country 0 0
Phone 0 0
+61 2 8627 1185
Fax 0 0
Email 0 0
shona.silvester@sydney.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified participant data and images will be made available for other scientific research.

Supporting document/s available: Study protocol
When will data be available (start and end dates)?
Data will be made available following publication of the final analysis, and for a minimum of 2 years thereafter.
Available to whom?
Requests must be made to the original researchers for access to the data.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04086082