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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06708221




Registration number
NCT06708221
Ethics application status
Date submitted
13/11/2024
Date registered
27/11/2024

Titles & IDs
Public title
A Master Trial Assessing the Technical Feasibility of First-In-Human Real-Time Image Guided Radiation Therapy Methods
Scientific title
Real-Time IGRT: a Master Trial Assessing the Technical Feasibility of First-In-Human Real-Time Image Guided Radiation Therapy Methods
Secondary ID [1] 0 0
RealTimeIGRT
Universal Trial Number (UTN)
Trial acronym
Real-Time IGRT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Real-Time Image Guided Radio Therapy (IGRT)

Experimental: Real-Time IGRT - Real-Time IGRT


Treatment: Devices: Real-Time Image Guided Radio Therapy (IGRT)
Real-time image guided radiation therapy (IGRT) methods image the cancerous tumour in real-time, enabling the treatment beam to focus its destructive energy on the patient's cancer, not their healthy tissue.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Successful application of Real-Time IGRT
Timepoint [1] 0 0
From the date of enrolment until 90 days after the completion of radiotherapy treatment

Eligibility
Key inclusion criteria
* Patients 18 years or older to be treated with curative radiation therapy
* Patients with brain, breast, head and neck, kidney, liver, lung, pancreas, prostate or spine cancer
* ECOG performance status 0-2
* Ability to understand and the willingness to sign a written informed consent document
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnancy,
* Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements or severe psychiatric illness/social situation
* Additional inclusion and exclusion criteria may apply to a specific sub-study

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
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2030
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 0 0
2170 - Liverpool

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Medical Research Future Fund
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Paul Keall
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
Shona Silvester
Address 0 0
Country 0 0
Phone 0 0
+61 2 86271185
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?
Aligned with the NHMRC's Open Access Policy and the Health Studies Australian National Data Asset (HeSANDA) program, the Real-Time IGRT trial will aim to make the de-identified trial data publicly available for other scientific research via an external research data repository, archive or register. E.g. The Cancer Imaging Archives (TCIA, https://www.cancerimagingarchive.net/). Study data that are provided to an external research data repository will be stored at and managed by the external repository. Data will only be shared with repositories whose function has been reviewed and approved by an accredited Research Integrity/Ethics Committee/Board, under a Materials Transfer Agreement with the University.

Supporting document/s available: Study protocol
When will data be available (start and end dates)?
Available following publication of final analysis, for a minimum of 5 years
Available to whom?
Researchers will be able to access de-identified trial information from an external research data repository, archive or register.
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/NCT06708221