Gynecologic CancerNCT04705467
3DUS Imaging of Needles in Gynecological Brachytherapy
A study testing Gynecological brachytherapy in people with Gynecologic Cancer, run by Western University, Canada at 1 site in Canada.
Trial summary
Brachytherapy treatment in gynecological cancers is an essential component to delivering adequate doses of radiation to a tumour while sparing normal tissue. Interstitial or intra-cavitary brachytherapy are often needed in advanced or recurrent disease, in cases where intrauterine brachytherapy may not deliver the… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- Gynecological brachytherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- 15 Oct 2022to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females of age eighteen (18) or greater.
- Patients with locally advanced or recurrent gynecological malignancies who are offered interstitial or ring and tandem brachytherapy treatment. These typically would include patients with primary or recurrent vaginal cancers, endometrial cancers or cervical cancers. Histologies of these cancers are typically adenocarcinomas or squamous cell carcinomas
Who cannot join
- Above patients who are not offered interstitial brachytherapy as a treatment modality
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
London Regional Cancer Program, Victoria Hospital
London, Ontario, N6A 5W9
David D'Souza, MD, 519-685-8500 ext. 53601, David.DSouza@lhsc.on.ca
About this study
Official title: A Multi-Modality Comparison of Needle Placement During Gynecological Brachytherapy Procedures
Brachytherapy treatment in gynecological cancers is an essential component to delivering adequate doses of radiation to a tumour while sparing normal tissue. Interstitial or intra-cavitary brachytherapy are often needed in advanced or recurrent disease, in cases where intrauterine brachytherapy may not deliver the optimal outcome. Interstitial or intra-cavitary brachytherapy are based on a defined template-and-needle system, and the procedure relies on clinical examination and pre-treatment imaging to guide needle insertion. There is currently no standard image-guided process to help direct needles in the pelvis. We propose using 3D ultrasound to provide real-time imaging for the brachytherapy procedure, which will aid in avoiding needle insertion into pelvic organs and result in optimal dose coverage to the tumour.
- Conditions
- Gynecologic Cancer
- Being tested
- Gynecological brachytherapy
- Keywords
- 3D Ultrasound, Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gynecological brachytherapyDevice
Management of gynecological malignancies is done through brachytherapy treatment, which involves the delivery of radiation via radioactive sources that are placed into or in close proximity to the tumour.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Other | Device: Gynecological brachytherapy requiring an Interstitial or ring and tandem insert involves insertion of the needle and applicators with no standard real-time image guidance. Occasionally 2-dimensional ultrasound is used, but it greatly limited by its flat nature, preventing a volumetric view of the needle pathways. Interstitial brachytherapy is done under general anesthesia. The trans-abdominal and trans-rectal standard 2D ultrasound that are used in some cases, will be expanded to 3D dimensional imaging through the use of an investigational device. Pre-procedure imaging in the form of MRI is used to help guide needles insertion as well as the clinical exam. Post-procedure CT is done for radiation planning. Receives: Device: Gynecological brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Needle Localization Accuracy
Observed needle locations in 3-D TVUS and CT planning images are measured and compared.
Measured: 16 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start15 Oct 2022
- Primary completionOct 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients who are assigned to gynecological brachytherapy
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705467
- Sponsor's protocol ID
- 10812
- Status last verified
- Nov 2024
- First submitted
- 16 Dec 2020
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Modality Comparison of Needle Placement During Gynecological Brachytherapy Procedures
- ClinicalTrials.gov ID
- NCT04705467
- Acronym / sponsor ID
- 10812
- Conditions
- Gynecologic Cancer
- Keywords
- 3D Ultrasound, Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Brachytherapy treatment in gynecological cancers is an essential component to delivering adequate doses of radiation to a tumour while sparing normal tissue. Interstitial or intra-cavitary brachytherapy are often needed in advanced or recurrent disease, in cases where intrauterine brachytherapy may not deliver the optimal outcome. Interstitial or intra-cavitary brachytherapy are based on a defined template-and-needle system, and the procedure relies on clinical examination and pre-treatment imaging to guide needle insertion. There is currently no standard image-guided process to help direct needles in the pelvis. We propose using 3D ultrasound to provide real-time imaging for the brachytherapy procedure, which will aid in avoiding needle insertion into pelvic organs and result in optimal dose coverage to the tumour.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients who are assigned to gynecological brachytherapy
| Arm | Type | Receives |
|---|---|---|
| Patients | Other | Device: Gynecological brachytherapyDevice: Gynecological brachytherapy requiring an Interstitial or ring and tandem insert involves insertion of the needle and applicators with no standard real-time image guidance. Occasionally 2-dimensional ultrasound is used, but it greatly limited by its flat nature, preventing a volumetric view of the needle pathways. Interstitial brachytherapy is done under general anesthesia. The trans-abdominal and trans-rectal standard 2D ultrasound that are used in some cases, will be expanded to 3D dimensional imaging through the use of an investigational device. Pre-procedure imaging in the form of MRI is used to help guide needles insertion as well as the clinical exam. Post-procedure CT is done for radiation planning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Females of age eighteen (18) or greater.
- Patients with locally advanced or recurrent gynecological malignancies who are offered interstitial or ring and tandem brachytherapy treatment. These typically would include patients with primary or recurrent vaginal cancers, endometrial cancers or cervical cancers. Histologies of these cancers are typically adenocarcinomas or squamous cell carcinomas
Key exclusion criteria (1 listed)
- Above patients who are not offered interstitial brachytherapy as a treatment modality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gynecological brachytherapyManagement of gynecological malignancies is done through brachytherapy treatment, which involves the delivery of radiation via radioactive sources that are placed into or in close proximity to the tumour. | Device | Patients |
Primary outcome
Needle Localization Accuracy
Time frame: 16 Months
Observed needle locations in 3-D TVUS and CT planning images are measured and compared.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gynecological brachytherapy in people with Gynecologic Cancer, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David D'Souza, MD (519-685-8500 ext. 53601, David.DSouza@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Needle Localization Accuracy (time frame: 16 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.