3DUS Imaging of Needles in Gynecological Brachytherapy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWestern University, Canada

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Gynecological brachytherapy

    Device

    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.

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: PatientsOther 1 intervention

Trial outcomes

Primary outcomes

1

Needle Localization Accuracy

Observed needle locations in 3-D TVUS and CT planning images are measured and compared.

Time frame
16 Months

Secondary outcomes

Other outcomes

Sponsors and contacts

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