Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001406392
Ethics application status
Approved
Date submitted
20/09/2017
Date registered
4/10/2017
Date last updated
17/11/2020
Date data sharing statement initially provided
17/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Study of the use of MRI for radiation therapy treatment planning for patients with complex pelvic cancers
Scientific title
The feasibility of MRI only Radiation Therapy Planning for patients with cancer of the Anal Canal, Rectum, Cervix or Endometrium
Secondary ID [1] 292936 0
None
Universal Trial Number (UTN)
U1111-1202-4412
Trial acronym
MARVEL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rectal Cancer 304817 0
Anal Canal Cancer 304818 0
Endometrial Cancer 304819 0
Cervical Cancer 304820 0
Condition category
Condition code
Cancer 304121 304121 0 0
Bowel - Anal
Cancer 304122 304122 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 304123 304123 0 0
Womb (Uterine or endometrial cancer)
Cancer 304124 304124 0 0
Cervical (cervix)

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study involves an additional MRI scan being required for the study. This will require attendance at one MRI scan session of a half hour duration from the participant. This modification does not affect the gold standard of imaging the patients would otherwise receive for their treatment. This MRI scan will be undertaken at the Diagnostic Imaging Department, Calvary Mater Newcastle, scheduled on the same day as the participants planning CT scan. There will be no change to the participant’s treatment in this study – they will receive the gold standard of care and treatment as per departmental protocols. The MRI scan will be used for comparative purposes only.
The MRI will be used to create a "synthetic CT scan" which will be used prospectively to compare to the participants previously acquired CT scan
Intervention code [1] 299168 0
Not applicable
Comparator / control treatment
The comparator/control will be the participant's planning CT scan which is acquired as per department protocol for their radiotherapy treatment planning
Control group
Active

Outcomes
Primary outcome [1] 303442 0
This is a composite primary outcome to demonstrate the mean dosimetric agreement and 95% confidence interval between conventional CT and synthetic CT for radiotherapy treatment planning of cancers of the rectum, anal canal, endometrium and cervix
Timepoint [1] 303442 0
after completion of radiotherapy treatment planning
Secondary outcome [1] 338941 0
To demonstrate the Hounsfield Unit comparison of conventional CT and synthetic CT for complex pelvic cancers using mean absolute error
Timepoint [1] 338941 0
after completion of radiotherapy treatment planning
Secondary outcome [2] 338942 0
To demonstrate the generation of digitally reconstructed radiographs (DRR’s) from synthetic CT for on treatment guidance. A mock image guidance alignment will be performed using synthetic CT DRR based alignment and cone-bean CT based alignment. The differences in these measurements compared to the gold standard CT will be quantified
Timepoint [2] 338942 0
after completion of radiotherapy treatment planning

Eligibility
Key inclusion criteria
1. >18 years of age
2. Patient able to provide informed consent
3. Histological diagnosis of a malignancy of the rectum, anal canal, cervix or endometrium
4. To be treated definitively with radical Radiotherapy +/- concurrent chemotherapy +/- surgery
5. Suitable for IMRT or VMAT planning
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. ECOG performance status >1
2. Clinical evidence of distant metastatic disease
3. Women who are pregnant or lactating
4. Inability to have a MRI due to:
a. Implanted magnetic metal e.g. intraocular metal, aneurysm clip, or other metallic implant
b. Pacemaker/ implanted defibrillator
c. Extreme claustrophobia
5. Mental impairment/intellectual impairment in which the patient would have difficulty giving informed consent to the study
6. Bariatric patients (patients with a BMI > 30)

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
The sample size will consist of 40 patients (20 male and 20 female patients) diagnosed with histologically confirmed malignancy of the rectum, anal canal, cervix or endometrium indicated for definitive radiotherapy, and who are eligible to undergo an MRI examination.
Prior experience in early phase development of the synthetic CT software suggests that a minimum sample of 20 participants is required to create an accurate sCT atlas. The contouring atlas which is used for this study to develop the synthetic CT scans cannot generalise between genders, therefore males and females would be required to be separated into 2 different groups. As 20 participants of each group will need to be recruited to generate a reliable sCT atlas, 40 patients will be recruited to the study; 20 male patients and 20 female patients. Assuming the dose difference at the representative voxel is 1.5% (based on content knowledge and prior experience), a sample of 20 participants, each with a CT and sCT, will enable estimation of the mean percentage dose difference and 95% confidence interval with a 0.7% (absolute) margin of error.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/10/2017
Actual
22/01/2018
Date of last participant enrolment
Anticipated
10/10/2019
Actual
18/11/2019
Date of last data collection
Anticipated
24/10/2019
Actual
9/12/2019
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9077 0
Calvary Mater Newcastle - Waratah
Recruitment postcode(s) [1] 17570 0
2298 - Waratah

Funding & Sponsors
Funding source category [1] 297563 0
Hospital
Name [1] 297563 0
Calvary Mater Newcastle -Margaret Mitchell Research Grant
Country [1] 297563 0
Australia
Primary sponsor type
Individual
Name
Laura O'Connor
Address
Radiation Oncology
Calvary Mater Newcastle,
Locked Bag 7,
Hunter Region Mail Centre, NSW 2310
Country
Australia
Secondary sponsor category [1] 296574 0
Individual
Name [1] 296574 0
Peter Greer
Address [1] 296574 0
Radiation Oncology,
Calvary Mater Newcastle Locked Bag 7
Hunter Region Mail Centre
NSW 2310
Country [1] 296574 0
Australia
Other collaborator category [1] 279741 0
Individual
Name [1] 279741 0
Jason Dowling
Address [1] 279741 0
CSIRO Health and Biosecurity
Level 5
UQ Health Science Building 901/16
Herston, QLD, 4029
Country [1] 279741 0
Australia
Other collaborator category [2] 279742 0
Individual
Name [2] 279742 0
Jarad Martin
Address [2] 279742 0
Radiation Oncology,
Calvary Mater Newcastle,
Locked Bag 7,
Hunter Region Mail Centre,
NSW 2310
Country [2] 279742 0
Australia
Other collaborator category [3] 279743 0
Individual
Name [3] 279743 0
Helen Warren-Froward
Address [3] 279743 0
School of Health Sciences
University of Newcastle
Callaghan
NSW
2308
Country [3] 279743 0
Australia
Other collaborator category [4] 279744 0
Individual
Name [4] 279744 0
Geetha Govindarajulu
Address [4] 279744 0
Radiation Oncology,
Calvary Mater Newcastle,
Locked Bag 7,
Hunter Region Mail Centre,
NSW 2310
Country [4] 279744 0
Australia
Other collaborator category [5] 279745 0
Individual
Name [5] 279745 0
Anne Capp
Address [5] 279745 0
Radiation Oncology,
Calvary Mater Newcastle,
Locked Bag 7,
Hunter Region Mail Centre,
NSW 2310
Country [5] 279745 0
Australia
Other collaborator category [6] 279746 0
Individual
Name [6] 279746 0
Mahesh Kumar
Address [6] 279746 0
Radiation Oncology,
Calvary Mater Newcastle,
Locked Bag 7,
Hunter Region Mail Centre,
NSW 2310
Country [6] 279746 0
Australia
Other collaborator category [7] 279747 0
Individual
Name [7] 279747 0
Swetha Sridharan
Address [7] 279747 0
Radiation Oncology,
Calvary Mater Newcastle,
Locked Bag 7,
Hunter Region Mail Centre,
NSW 2310
Country [7] 279747 0
Australia
Other collaborator category [8] 279748 0
Individual
Name [8] 279748 0
Leah Best
Address [8] 279748 0
Radiology Department
Hunter New England Health Care
Calvary Mater Campus
Waratah
NSW 2310
Country [8] 279748 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298658 0
Hunter New England Health District Human Research Ethics Committee
Ethics committee address [1] 298658 0
Ethics committee country [1] 298658 0
Australia
Date submitted for ethics approval [1] 298658 0
21/06/2017
Approval date [1] 298658 0
29/08/2017
Ethics approval number [1] 298658 0
17/06/21/3.02

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2063 2063 0 0
/AnzctrAttachments/373684-1706213.02 Ongoing Approval Clinical Trial Single-site LeadHREC.pdf (Ethics approval)
Attachments [2] 2064 2064 0 0
/AnzctrAttachments/373684-CLINICAL STUDY PROTOCOL - MARVEL V2.3.pdf (Protocol)
Attachments [3] 2065 2065 0 0
/AnzctrAttachments/373684-Participant Information and Consent v1.3.pdf (Participant information/consent)

Contacts
Principal investigator
Name 77794 0
Ms Laura O'Connor
Address 77794 0
Radiation Oncology
Calvary Mater Newcastle,
Locked Bag 7,
Hunter Region Mail Centre, NSW 2310
Country 77794 0
Australia
Phone 77794 0
+61 2 40143168
Fax 77794 0
+61 2 4014 3169
Email 77794 0
Laura.O'[email protected]
Contact person for public queries
Name 77795 0
Laura O'Connor
Address 77795 0
Radiation Oncology
Calvary Mater Newcastle,
Locked Bag 7,
Hunter Region Mail Centre, NSW 2310
Country 77795 0
Australia
Phone 77795 0
+61 2 40143168
Fax 77795 0
+61 2 4014 3169
Email 77795 0
Laura.O'[email protected]
Contact person for scientific queries
Name 77796 0
Laura O'Connor
Address 77796 0
Radiation Oncology
Calvary Mater Newcastle,
Locked Bag 7,
Hunter Region Mail Centre, NSW 2310
Country 77796 0
Australia
Phone 77796 0
+61 2 40143168
Fax 77796 0
+61 2 4014 3169
Email 77796 0
Laura.O'[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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
SourceTitleYear of PublicationDOI
EmbaseValidation of an MRI-only planning workflow for definitive pelvic radiotherapy.2022https://dx.doi.org/10.1186/s13014-022-02023-4
N.B. These documents automatically identified may not have been verified by the study sponsor.