3D Ultrasound-Guided Brachytherapy for Gynecologic Cancers

Overseen By David D'Souza, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Western University, Canada

Disqualifiers: Not offered brachytherapy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

35 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment 3D Ultrasound-Guided Brachytherapy for Gynecologic Cancers?

Research shows that using ultrasound guidance in brachytherapy for gynecologic cancers can improve the accuracy of the treatment, reduce complications like uterine perforations, and enhance the effectiveness of radiation therapy by better targeting the cancerous areas. ^{1 2 3 4 5}

Is 3D Ultrasound-Guided Brachytherapy for Gynecologic Cancers safe?

Brachytherapy, including 3D ultrasound-guided techniques, is generally considered safe for treating gynecologic cancers, with advances reducing complications and side effects. However, some risks like organ puncture and related toxicity exist, but improvements in techniques and patient stabilization have enhanced safety. ^{4 6 7 8 9}

How is 3D Ultrasound-Guided Brachytherapy different from other treatments for gynecologic cancers?

3D Ultrasound-Guided Brachytherapy is unique because it uses advanced imaging techniques to precisely guide the placement of radioactive sources directly into or near the tumor, improving accuracy and reducing the risk of damaging nearby organs. This method enhances the effectiveness of the treatment by allowing for better dose control and minimizing side effects compared to traditional methods. ^{1 3 4 10 11}

Eligibility Criteria

This trial is for women aged 18 or older with advanced or recurrent gynecological cancers, such as vaginal, endometrial, or cervical cancers. It's specifically for those who are recommended to receive interstitial or ring and tandem brachytherapy treatments.

Inclusion Criteria

I am a woman aged 18 or older.

I have advanced or recurrent cancer in my reproductive organs and am offered a specific radiation treatment.

Exclusion Criteria

I am not being considered for internal radiation treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment Imaging

Pre-procedure imaging in the form of MRI is used to help guide needle insertion as well as the clinical exam

1 week

1 visit (in-person)

Brachytherapy Treatment

Participants undergo gynecological brachytherapy with 3D ultrasound guidance to optimize needle placement and dose coverage

1-2 weeks

1-2 visits (in-person)

Post-procedure Imaging

Post-procedure CT is done for radiation planning

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Gynecological Brachytherapy

Trial Overview The study tests the use of real-time 3D ultrasound imaging during brachytherapy procedures in gynecologic cancer treatment. The goal is to improve needle placement accuracy and avoid damage to pelvic organs while ensuring the tumor receives an optimal dose.

Participant Groups

Group I: Patients Experimental Treatment 1 Intervention

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.

Gynecological Brachytherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Brachytherapy for:

• Cervical cancer
• Endometrial cancer
• Vaginal cancer
• Uterine cancer

Approved in United States as Brachytherapy for:

• Cervical cancer
• Endometrial cancer
• Vaginal cancer
• Uterine cancer
• Recurrent gynecological cancers

Approved in Canada as Brachytherapy for:

• Cervical cancer
• Endometrial cancer
• Vaginal cancer
• Uterine cancer

Approved in Japan as Brachytherapy for:

• Cervical cancer
• Endometrial cancer
• Vaginal cancer
• Uterine cancer

Approved in China as Brachytherapy for:

• Cervical cancer
• Endometrial cancer
• Vaginal cancer
• Uterine cancer

Approved in Switzerland as Brachytherapy for:

• Cervical cancer
• Endometrial cancer
• Vaginal cancer
• Uterine cancer

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

Findings from Research

A new transvaginal ultrasound-guided interstitial implant device was developed for precise brachytherapy in 56 patients with recurrent pelvic tumors, significantly improving the accuracy of needle placement and allowing for higher radiation doses of 80-100 Gy.

The technique enhances safety by reducing the risks of anesthesia and organ injury, making it a promising option for gynecological oncology patients with pelvic relapses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new technique for performing interstitial implants for gynecologic malignancies using transvaginal ultrasound guidance. Yan, XJ., Yang, Y., Chen, X., et al.[2022]

Intraoperative ultrasound (US) guidance significantly improved the safety of intracavitary brachytherapy for cervical cancer, reducing uterine perforation rates from 6.9% to just 0.9% among 113 patients.

The use of US guidance also minimized applicator misplacement, with only 0.9% of patients experiencing issues compared to higher rates before its implementation, demonstrating its efficacy in enhancing treatment accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative sonographic guidance for intracavitary brachytherapy of cervical cancer. Akbas, T., Ugurluer, G., Acil, M., et al.[2022]

The combined intracavitary/interstitial (IC/IS) approach for treating bulky and irregularly shaped gynecological tumors showed promising dosimetric results, achieving an average D90 HR-CTV of 118%, which is significantly higher than the 77% achieved with the intracavitary (IC) plan.

This method also maintained safety by ensuring that dose constraints for the bladder and rectum were met, indicating that IC/IS could be a less labor-intensive yet effective alternative to traditional interstitial brachytherapy (ISBT) for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can combined intracavitary/interstitial approach be an alternative to interstitial brachytherapy with the Martinez Universal Perineal Interstitial Template (MUPIT) in computed tomography-guided adaptive brachytherapy for bulky and/or irregularly shaped gynecological tumors? Oike, T., Ohno, T., Noda, SE., et al.[2021]

In a study of 160 patients with invasive cervical cancer, using trans-abdominal ultrasound guidance during intra-cavitary brachytherapy significantly reduced the uterine perforation rate from 12.5% to 1.25%.

The ultrasound-guided procedure also shortened the average treatment time from 26 minutes to 19 minutes and decreased radiation exposure to surrounding organs, indicating improved safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase III randomised trial of trans-abdominal ultrasound in improving application quality and dosimetry of intra-cavitary brachytherapy in locally advanced cervical cancer. Pareek, V., Barthwal, M., Giridhar, P., et al.[2021]

In a study of 172 cervical cancer patients, suboptimal implantation during brachytherapy was common, occurring in 31% of procedures, but did not lead to increased local failure or toxicity rates, indicating that the procedure can still be effective even with some implantation issues.

Failure to perform brachytherapy was linked to poorer local control and survival rates, highlighting the importance of this treatment in managing cervical cancer, and suggesting that real-time ultrasound guidance could help improve implantation accuracy and increase the use of brachytherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of suboptimal tandem implantation on local control and complications in intracavitary brachytherapy for cervix cancer. Kissel, M., Silva, M., Lequesne, J., et al.[2020]

Intracavitary gynecologic brachytherapy is an effective treatment for cervical and uterine cancer, delivering targeted radiation with minimal side effects, thanks to advancements in technique that have reduced toxicity rates.

The use of EQD2 models helps integrate external beam radiotherapy with brachytherapy, allowing for better dose management and protection of surrounding organs, which is crucial for optimizing patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of intracavitary brachytherapy for gynecologic cancers and their management: A comprehensive review. Glaser, SM., Mohindra, P., Mahantshetty, U., et al.[2021]

In a study involving 25 patients with gynecological malignancies, noncolocated interstitial brachytherapy was found to be a safe and effective method for delivering treatment, with minimal transport-associated toxicities observed during 234 patient transports.

Using enhanced patient stabilization methods, such as a positioning board, significantly reduced the incidence of overall toxicities and infections compared to standard transport methods, suggesting that improved patient support can enhance safety during brachytherapy procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote location interstitial brachytherapy with patient stabilization and subsequent transport to an outpatient center for treatment is safe and effective for the treatment of gynecologic malignancies. Tumati, V., Folkert, MR., Lawson, S., et al.[2019]

In a study of 36 patients undergoing interstitial brachytherapy for gynecologic cancers, visceral puncture (such as bowel and bladder) did not lead to increased acute or late toxicity, suggesting it is a safe practice when source dwell times are minimized.

The treatment resulted in a 78% locoregional control rate, with most patients discharged within 3 days, indicating that interstitial brachytherapy can be effective and has manageable side effects even with some visceral punctures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicity associated with bowel or bladder puncture during gynecologic interstitial brachytherapy. Shah, AP., Strauss, JB., Gielda, BT., et al.[2016]

High-dose intracavitary brachytherapy was evaluated in 55 patients over two years, demonstrating safety and reliability in treating gynecological cancers, both before and after surgery.

The method allowed for precise dosimetric calculations to minimize radiation exposure to surrounding organs like the bladder and rectum, ensuring effective treatment while maintaining safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[High-dose gynecologic endocavitary brachytherapy. Technical and dosimetric aspects]. Grillo Ruggieri, F., Parietti, E., Bistolfi, F., et al.[2008]

A new 360-degree three-dimensional transvaginal ultrasound (3-D TVUS) system has been developed to improve the accuracy of needle placement during high-dose-rate interstitial brachytherapy for vaginal tumors, enhancing treatment precision.

In a study involving six patients, the 3-D TVUS successfully visualized anatomical features and all inserted needles, suggesting it could significantly improve intraoperative guidance and reduce the risk of damaging nearby organs during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative 360-deg three-dimensional transvaginal ultrasound during needle insertions for high-dose-rate transperineal interstitial gynecologic brachytherapy of vaginal tumors. Rodgers, JR., Bax, J., Surry, K., et al.[2020]

Doppler ultrasound (US) effectively guided needle placement for interstitial brachytherapy in 11 cervical cancer patients, helping to avoid blood vessels and preventing hemorrhage during the procedure.

The study found that the average number of blood vessels was higher in the superior cervix for larger tumors, indicating that Doppler US can provide critical real-time anatomical information to enhance the safety and efficacy of brachytherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time Doppler ultrasound to identify vessels and guide needle placement for gynecologic interstitial brachytherapy. Sethi, R., Kuo, YC., Edraki, B., et al.[2019]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

A new technique for performing interstitial implants for gynecologic malignancies using transvaginal ultrasound guidance. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Intraoperative sonographic guidance for intracavitary brachytherapy of cervical cancer. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Can combined intracavitary/interstitial approach be an alternative to interstitial brachytherapy with the Martinez Universal Perineal Interstitial Template (MUPIT) in computed tomography-guided adaptive brachytherapy for bulky and/or irregularly shaped gynecological tumors? [2021]

4. United States pubmed.ncbi.nlm.nih.gov

A phase III randomised trial of trans-abdominal ultrasound in improving application quality and dosimetry of intra-cavitary brachytherapy in locally advanced cervical cancer. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Impact of suboptimal tandem implantation on local control and complications in intracavitary brachytherapy for cervix cancer. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Complications of intracavitary brachytherapy for gynecologic cancers and their management: A comprehensive review. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Remote location interstitial brachytherapy with patient stabilization and subsequent transport to an outpatient center for treatment is safe and effective for the treatment of gynecologic malignancies. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Toxicity associated with bowel or bladder puncture during gynecologic interstitial brachytherapy. [2016]

9. Italy pubmed.ncbi.nlm.nih.gov

[High-dose gynecologic endocavitary brachytherapy. Technical and dosimetric aspects]. [2008]

10. United States pubmed.ncbi.nlm.nih.gov

Intraoperative 360-deg three-dimensional transvaginal ultrasound during needle insertions for high-dose-rate transperineal interstitial gynecologic brachytherapy of vaginal tumors. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Real-time Doppler ultrasound to identify vessels and guide needle placement for gynecologic interstitial brachytherapy. [2019]