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Spacer in Gynaecological MRI-guided brachytherapy: A feasibility study

Spacer in Gynaecological MRI-guided brachytherapy: A feasibility study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000167460
Acronym
SIGMA
Enrollment
10
Registered
2025-02-13
Start date
2024-05-27
Completion date
2026-01-31
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 comp

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.

Sponsors

Austin Health
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Exclusion criteria

1. Known allergy to hyaluronic acid 2. Rectal invasion 3. Contraindication to radiotherapy, including brachytherapy 4. Contraindication to MRI 5. Pregnancy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026