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Trial registered on ANZCTR


Registration number
ACTRN12625000167460
Ethics application status
Approved
Date submitted
13/01/2025
Date registered
13/02/2025
Date last updated
13/02/2025
Date data sharing statement initially provided
13/02/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Spacer in Gynaecological MRI-guided brachytherapy: A feasibility study
Scientific title
Spacer in Gynaecological MRI-guided brachytherapy: A feasibility study
Secondary ID [1] 313696 0
None
Universal Trial Number (UTN)
Trial acronym
SIGMA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gynaecological cancer 336281 0
Condition category
Condition code
Cancer 332822 332822 0 0
Cervical (cervix)
Cancer 332823 332823 0 0
Womb (Uterine or endometrial cancer)
Cancer 332824 332824 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Insertion of hyaluronic acid gel spacer (Barrigel) into the rectovaginal space in participants with in situ gynaecological cancer treated with high dose rate brachytherapy.

Barrigel is used as a rectal spacer in prostate cancer radiation therapy but has had limited use in gynaecological cancers.

Hyaluronic acid gel spacer insertion:
The first brachytherapy session will proceed as per standard of care without spacer and will act as a control to explore the secondary outcome of dosimetric comparison. Insertion of the hyaluronic acid spacer will occur with the second fraction of brachytherapy, however, due to resource limitations including personnel, theatre time and relevant equipment, this may not be feasible and may occur with a different fraction.

Spacer insertion will occur at the institution operating theatre under general (or spinal) anaesthesia, approximately 10-30 minutes prior to gynaecological brachytherapy applicator insertion. The radiation oncologist will inject Barrigel transvaginally or transperineally into the rectovaginal space under transrectal ultrasound guidance to increase the space between the rectum and gynaecological target (cervix and/or vagina). The volume injected will be at the discretion of the radiation oncologist based on individual anatomy. The radiation oncologist will insert the brachytherapy applicator immediately after spacer insertion and the participant will then continue with standard MRI-guided brachytherapy processes per institution protocol. There will only be one spacer insertion for the entire brachytherapy course which may comprise of 3-4 brachytherapy sessions.

Additional MRI scans (imaging only without brachytherapy) will be performed at 3 months and 12 months to assess for presence of the gel and characteristics.
Intervention code [1] 330292 0
Treatment: Devices
Intervention code [2] 330477 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340350 0
Feasibility - successful placement of hyaluronic acid spacer between rectum and cervix/vagina.
Timepoint [1] 340350 0
Day of spacer insertion
Secondary outcome [1] 443788 0
Spacer visibility on MRI
Timepoint [1] 443788 0
Within 48 hours of spacer insertion, at the end of brachytherapy course, 3 months and 12 months following brachytherapy course.
Secondary outcome [2] 443789 0
Adverse events/toxicities
Timepoint [2] 443789 0
Prior to spacer insertion, within 48 hours of spacer insertion, at the end of brachytherapy course, 3 months and 12 months following brachytherapy course.
Secondary outcome [3] 443791 0
Dose volume histogram parameters for rectum
Timepoint [3] 443791 0
At each brachytherapy fraction
Secondary outcome [4] 443792 0
Quality of life (all cancer)
Timepoint [4] 443792 0
Prior to spacer insertion, 4-6 weeks, 3 months, 6 months and 12 months following brachytherapy course.
Secondary outcome [5] 444395 0
Quality of life (cervical cancer)
Timepoint [5] 444395 0
Prior to spacer insertion, 4-6 weeks, 3 months, 6 months and 12 months following brachytherapy course.
Secondary outcome [6] 444397 0
Spacer insertion-related complications
Timepoint [6] 444397 0
Within 48 hours of spacer insertion, at the end of brachytherapy course, 3 months and 12 months following brachytherapy course.
Secondary outcome [7] 444398 0
Spacer size
Timepoint [7] 444398 0
Within 48 hours of spacer insertion, at the end of brachytherapy course, 3 months and 12 months following brachytherapy course.

Eligibility
Key inclusion criteria
1. Age greater than or equal to 18 years
2. Cancer involving female gynaecological tract (cervix, uterus and/or vagina)
3. Biopsy confirmed malignancy of any histology
4. Intention to treat with MRI-guided high dose rate brachytherapy
5. MRI of pelvis at diagnosis is performed
6. PET/CT at diagnosis is performed
7. Written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known allergy to hyaluronic acid
2. Rectal invasion
3. Contraindication to radiotherapy, including brachytherapy
4. Contraindication to MRI
5. Pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
27/05/2024
Date of last participant enrolment
Anticipated
31/01/2026
Actual
Date of last data collection
Anticipated
31/03/2027
Actual
Sample size
Target
24
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27483 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 43592 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 318163 0
Hospital
Name [1] 318163 0
Austin Health
Country [1] 318163 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Country
Australia
Secondary sponsor category [1] 320545 0
None
Name [1] 320545 0
Address [1] 320545 0
Country [1] 320545 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316811 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 316811 0
Ethics committee country [1] 316811 0
Australia
Date submitted for ethics approval [1] 316811 0
Approval date [1] 316811 0
10/04/2024
Ethics approval number [1] 316811 0
HREC/103210/Austin-2023

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

Contacts
Principal investigator
Name 139078 0
Dr Carminia Lapuz
Address 139078 0
Austin Health, 145 Studley Road, Heidelberg, VIC, 3084
Country 139078 0
Australia
Phone 139078 0
+61 3 9496 9803
Fax 139078 0
Email 139078 0
carminia.lapuz@austin.org.au
Contact person for public queries
Name 139079 0
Carminia Lapuz
Address 139079 0
Austin Health, 145 Studley Road, Heidelberg, VIC, 3084
Country 139079 0
Australia
Phone 139079 0
+61 3 9496 2800
Fax 139079 0
Email 139079 0
carminia.lapuz@austin.org.au
Contact person for scientific queries
Name 139080 0
Carminia Lapuz
Address 139080 0
Austin Health, 145 Studley Road, Heidelberg, VIC, 3084
Country 139080 0
Australia
Phone 139080 0
+61 3 9496 2800
Fax 139080 0
Email 139080 0
carminia.lapuz@austin.org.au

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
No additional documents have been identified.