Feasibility Study for Ultrasound-Guided Interstitial Brachytherapy for Gynecological CancersV2

NCT04336683 | Completed

• 1 other identifier: 106088
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Brachytherapy treatment in gynecological cancers is an essential component to delivering adequate doses of radiation to a tumour while sparing normal tissue. Interstitial and intracavitary brachytherapy is often needed in advanced or recurrent disease, in cases where intrauterine brachytherapy may not deliver the optimal outcome. Interstitial brachytherapy is 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. The investigators propose a 3D ultrasound device that will 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

Keywords

3D Ultrasound; Intervention

Outcome Measures

Primary Outcomes (1)

• Efficacy of the 3DUS device to visualize applicators

  The number of applicators identified within the 3D ultrasound image.

  16 Weeks

Secondary Outcomes (1)

• 3DUS to CT Fusion

  16 Weeks

Study Arms (1)

Patient

OTHER

Patients undergoing gynecological brachytherapy, will be imaged with a 3D ultrasound medical device for the purpose of efficacy testing.

Device: Interstitial and intracavitary brachytherapy

Interventions

Interstitial and intracavitary brachytherapy DEVICE

Standard of care in interstitial or intracavitary brachytherapy is to insert the brachytherapy needle and applicator with no standard real-time image guidance. Interstitial brachytherapy is done under general anesthesia. Trans-abdominal and trans-rectal standard 2D ultrasound is used in some cases, but is typically not consistent and therefore its value is limited. 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

Patient

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Females patients with locally advanced or recurrent gynecological malignancies who are offered interstitial or intracavitary brachytherapy treatment.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with locally advanced or recurrent gynecological malignancies who are offered interstitial or intracavitary 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

You may not qualify if:

• Above patients who are not offered interstitial or intracavitary brachytherapy as a treatment modality

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

London Regional Cancer Program, Victoria Hospital

London, Ontario, N6A 5W9, Canada

Location

Related Publications (3)

• Rodgers JR, Hrinivich WT, Surry K, Velker V, D'Souza D, Fenster A. A semiautomatic segmentation method for interstitial needles in intraoperative 3D transvaginal ultrasound images for high-dose-rate gynecologic brachytherapy of vaginal tumors. Brachytherapy. 2020 Sep-Oct;19(5):659-668. doi: 10.1016/j.brachy.2020.05.006. Epub 2020 Jul 3.

  PMID: 32631651 RESULT

• Rodgers JR, Bax J, Surry K, Velker V, Leung E, D'Souza D, Fenster A. Intraoperative 360-deg three-dimensional transvaginal ultrasound during needle insertions for high-dose-rate transperineal interstitial gynecologic brachytherapy of vaginal tumors. J Med Imaging (Bellingham). 2019 Apr;6(2):025001. doi: 10.1117/1.JMI.6.2.025001. Epub 2019 Apr 8.

  PMID: 30989088 RESULT

• Rodgers JR, Mendez LC, Hoover DA, Bax J, D'Souza D, Fenster A. Feasibility of fusing three-dimensional transabdominal and transrectal ultrasound images for comprehensive intraoperative visualization of gynecologic brachytherapy applicators. Med Phys. 2021 Oct;48(10):5611-5623. doi: 10.1002/mp.15175. Epub 2021 Sep 2.

  PMID: 34415069 RESULT

MeSH Terms

Interventions

Brachytherapy

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• David D'Souza, MD

  Schulich School of Medicine and Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients who are assigned to gynecological brachytherapy.

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: April 7, 2020
• Study Start: February 17, 2015
• Primary Completion: June 15, 2021
• Study Completion: April 7, 2022
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)