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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
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Scientific title
Spacer in Gynaecological MRI-guided brachytherapy: A feasibility study
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Secondary ID [1]
313696
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None
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Universal Trial Number (UTN)
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Trial acronym
SIGMA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gynaecological cancer
336281
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Condition category
Condition code
Cancer
332822
332822
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0
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Cervical (cervix)
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Cancer
332824
332824
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0
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Other cancer types
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Cancer
332823
332823
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0
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Womb (Uterine or endometrial cancer)
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
330292
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Treatment: Devices
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Intervention code [2]
330477
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Treatment: Other
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Feasibility - successful placement of hyaluronic acid spacer between rectum and cervix/vagina.
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Assessment method [1]
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MRI assessment of anatomical location of spacer deployment by radiologist and radiation oncologist.
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Timepoint [1]
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Day of spacer insertion
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Secondary outcome [1]
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Spacer visibility on MRI
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Assessment method [1]
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Visualisation score on MRI
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Timepoint [1]
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Within 48 hours of spacer insertion, at the end of brachytherapy course, 3 months and 12 months following brachytherapy course.
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Secondary outcome [2]
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Spacer size
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Assessment method [2]
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Spacer measurements on MRI
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Timepoint [2]
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Within 48 hours of spacer insertion, at the end of brachytherapy course, 3 months and 12 months following brachytherapy course.
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Secondary outcome [3]
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Quality of life (cervical cancer)
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Assessment method [3]
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EORTC QLQ-CX24
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Timepoint [3]
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Prior to spacer insertion, 4-6 weeks, 3 months, 6 months and 12 months following brachytherapy course.
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Secondary outcome [4]
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Dose volume histogram parameters for rectum
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Assessment method [4]
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Dose volume histogram parameters (MRI)
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Timepoint [4]
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At each brachytherapy fraction
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Secondary outcome [5]
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Spacer insertion-related complications
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Assessment method [5]
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Adverse event evaluation: Clinical assessment and participant reporting
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Timepoint [5]
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Within 48 hours of spacer insertion, at the end of brachytherapy course, 3 months and 12 months following brachytherapy course.
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Secondary outcome [6]
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Adverse events/toxicities
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Assessment method [6]
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CTCAE v5
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Timepoint [6]
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Prior to spacer insertion, within 48 hours of spacer insertion, at the end of brachytherapy course, 3 months and 12 months following brachytherapy course.
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Secondary outcome [7]
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Quality of life (all cancer)
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Assessment method [7]
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EORTC QLQ-C30
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Timepoint [7]
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Prior to spacer insertion, 4-6 weeks, 3 months, 6 months and 12 months following brachytherapy course.
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Known allergy to hyaluronic acid
2. Rectal invasion
3. Contraindication to radiotherapy, including brachytherapy
4. Contraindication to MRI
5. Pregnancy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
27/05/2024
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Date of last participant enrolment
Anticipated
31/01/2026
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Actual
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Date of last data collection
Anticipated
31/03/2027
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Actual
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Sample size
Target
24
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Accrual to date
10
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
27483
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Austin Health - Austin Hospital - Heidelberg
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Recruitment postcode(s) [1]
43592
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3084 - Heidelberg
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Austin Health
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Address [1]
318163
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Country [1]
318163
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Australia
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Primary sponsor type
Hospital
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Name
Austin Health
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
320545
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Address [1]
320545
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Country [1]
320545
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Austin Health Human Research Ethics Committee
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Ethics committee address [1]
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https://www.austin.org.au/Office-for-Research/
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
316811
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Approval date [1]
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10/04/2024
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Ethics approval number [1]
316811
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HREC/103210/Austin-2023
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Summary
Brief summary
This study aims to assess whether it is safe and possible to insert a hyaluronic acid gel spacer within the area between the vagina and rectum for patients who are undergoing brachytherapy for gynaecological cancers. Who is it for? You may be eligible for this study if you are female, aged 18 years or older, you have been diagnosed with cervical, uterine, and/or vaginal cancer and you will be undergoing MRI-guided high dose rate brachytherapy to treat your cancer. Study details Participants who choose to enrol in this study will undergo insertion of a gel spacer (Barrigel). Participants will have the spacer inserted under anaesthetic by the radiation oncologist prior to their second brachytherapy session. It is anticipated that the spacer will break down and be excreted by the body over 3-6 months. The researchers will also take additional MRI scans to determine the location and size of the spacer over a period of 12 months after insertion. It is hoped this research will determine that use of a gel spacer is safe and does not cause any unacceptable side effects for cancer patients who are undergoing MRI-guided brachytherapy. If this study finds that the spacer is safe and able to protect other organs that are not receiving therapy, a larger study enrolling a greater number of cancer patients may be undertaken.
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Trial website
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Trial related presentations / publications
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Public notes
Amendment approved 27/11/2024
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Contacts
Principal investigator
Name
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Dr Carminia Lapuz
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Address
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Austin Health, 145 Studley Road, Heidelberg, VIC, 3084
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Country
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Australia
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Phone
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+61 3 9496 9803
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Carminia Lapuz
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Address
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Austin Health, 145 Studley Road, Heidelberg, VIC, 3084
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Country
139079
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Australia
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Phone
139079
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+61 3 9496 2800
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Carminia Lapuz
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Address
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Austin Health, 145 Studley Road, Heidelberg, VIC, 3084
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Country
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Australia
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Phone
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+61 3 9496 2800
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Fax
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing 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.
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