Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001035314
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
9/07/2026
Date registered
Help: Date registered
24/08/2026
Date last updated
Help: Date last updated
24/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
24/08/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Development of a markerless approach to abdominal motion tracking during radiotherapy: an observation-only feasibility study
Scientific title
Development of an AI-guided approach to markerless tracking of abdominal targets and organs-at-risk (OARs) during radiotherapy
Additional trial identifiers [1] 317841 0
Nil
Universal Trial Number (UTN)
Trial acronym
MAMBA (Markerless Abdominal Motion tracking Based on Artificial intelligence)
Related trial records

Health condition
Health condition(s) studied:
Abdominal cancers 342767 0
Pancreatic cancer 342974 0
Liver cancer 342975 0
Kidney cancer 342976 0
Adrenal gland cancer 342977 0
Condition category
Condition code
Cancer 338897 338897 0 0
Pancreatic
Cancer 338898 338898 0 0
Liver
Cancer 338899 338899 0 0
Kidney
Cancer 338900 338900 0 0
Other cancer types

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of the intervention or exposure
This study evaluates a new method to track tumour and organ motion during radiotherapy. Using artificial intelligence, a customised 'motion model' will be created for each participant using their CT images. Depending on the participant’s standard of care treatment, this may involve the collection of 2 additional cone beam computed tomography (CBCT) images for model generation purposes. The model will be loaded into a research software by a Medical Physicist trained in the use of the software. The research software will be run at the time of treatment to measure the motion of critical structures such as the tumour, pancreas, duodenum, small bowel and/or stomach. X-ray imaging acquired as part of this study will act as inputs to the research software. Note that this is an observation-only study; the output of the research software will not be used to modify the participants' treatment. In the future, it is expected that the radiotherapy treatment team will use a software such as this to better direct the radiation towards the tumour and away from nearby organs based on the motion observed.
Participants will undergo additional x-ray imaging during their radiotherapy treatment sessions. This is to 1) enable to use of the research software and 2) to monitor the position of certain organs, to verify the output of each participant's motion model. Organs will be monitored if they are within 2 cm of the treatment area. This additional imaging will be acquired during 5 of the participants' standard treatment sessions, and is expected to extend the length of each treatment session by no more than 10 minutes. It is anticipated that trial data collection will be complete within a 2 week period.
Intervention code [1] 334680 0
Not applicable
Description of the comparator or control
The model output will be compared to the corresponding tumour/organ segmentation on the CBCT image acquired at the closest timepoint. These segmentations will be completed by experts in abdominal CT imaging. These segmentations will be transformed from 3D to 2D via back projection, to enable direct comparison to the model output.
Control group
Active

Outcomes
Primary outcome [1] 346130 0
Feasibility determined by the proportion of dose delivery time where the model successfully segments upper abdominal structures of interest.
Timepoint [1] 346130 0
To be assessed for each treatment session (over 5 sessions).
Secondary outcome [1] 464696 0
Evaluate the geometric accuracy of real-time target segmentations.
Timepoint [1] 464696 0
To be assessed for each treatment session (over 5 sessions).
Secondary outcome [2] 465397 0
Evaluate the geometric accuracy of real-time organ-at-risk segmentations.
Timepoint [2] 465397 0
To be assessed for each treatment session (over 5 sessions).

Eligibility
Key inclusion criteria
Receiving upper abdominal radiotherapy (pancreas, liver, kidney, adrenal gland) with a planning CT scan. If the site of treatment is not the pancreas, at least one of the specified organs-at-risk (duodenum, small bowel, stomach) must be present within a 2 cm margin of the planning target volume.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Tumour maximum dimension more than 12 cm and minimum dimension less than 1 cm, unable to give informed consent and/or pregnant women.

Study design
Purpose
Duration
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
18/05/2026
Date of last participant enrolment
Anticipated
4/05/2027
Actual
Date of last data collection
Anticipated
18/05/2027
Actual
Sample size
Target
20
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 29814 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 46167 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 322382 0
Commercial sector/Industry
Name [1] 322382 0
Varian Medical Systems, Inc. - A Siemens Healthineers Company
Country [1] 322382 0
United States of America
Funding source category [2] 322394 0
Hospital
Name [2] 322394 0
Royal North Shore Hospital
Country [2] 322394 0
Australia
Primary sponsor type
Government body
Name
Northern Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 325304 0
None
Name [1] 325304 0
Address [1] 325304 0
Country [1] 325304 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320884 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 320884 0
Ethics committee country [1] 320884 0
Australia
Date submitted for ethics approval [1] 320884 0
Approval date [1] 320884 0
16/12/2025
Ethics approval number [1] 320884 0
2025/ETH02456

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

Contacts
Principal investigator
Name 151950 0
A/Prof George Hruby
Address 151950 0
Level 1 Acute Services Building, Northern Sydney Cancer Centre, Royal North Shore Hospital, 1 Reserve Rd, St Leonards NSW 2065
Country 151950 0
Australia
Phone 151950 0
+61 2 94631300
Fax 151950 0
Email 151950 0
[email protected]
Contact person for public queries
Name 151951 0
Nada Cheikh-Ali
Address 151951 0
Northern Sydney Cancer Centre, Royal North Shore Hospital, 1 Reserve Rd, St Leonards, 2065 NSW
Country 151951 0
Australia
Phone 151951 0
+61 2 94631300
Fax 151951 0
Email 151951 0
[email protected]
Contact person for scientific queries
Name 151952 0
Maegan Stewart
Address 151952 0
Northern Sydney Cancer Centre, Royal North Shore Hospital, 1 Reserve Rd, St Leonards, 2065 NSW
Country 151952 0
Australia
Phone 151952 0
+61 2 94631300
Fax 151952 0
Email 151952 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies testing whether findings can be repeated or confirmed
• Similar studies investigating the application of markerless abdominal tracking models.

When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
A finite period of: 5 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Please contact [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.