Cancer Clinical Trial
Official title:
Development and Assessment of Individual 3D Printed Applicators in MRI Guided Gynecological Brachytherapy
MRI guided adaptive brachytherapy (BT) represents the gold standard in the treatment of gynecological cancers. Commercially available standard MRI compatible applicators for BT of gynecological cancers don't always allow for optimal target volume coverage. Three-dimensional (3D) printed technology enables versatile possibilities of improvement of standard applicators and development of novel applicators with better coverage of the target volume. The purpose of this study is to implement and assess 3D printing technology as an instrument for designing and manufacturing applicators for individualized BT of gynecological cancers.
Status | Recruiting |
Enrollment | 13 |
Est. completion date | January 2019 |
Est. primary completion date | May 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - patients with locally advanced gynecological cancer (cervical, uterine, vaginal, vulvar cancer) eligible for treatment with brachytherapy - squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma, histologically proven - patients fit for regional or general anesthesia - signed written informed consent Exclusion Criteria: - regional or general anesthesia contraindications - contraindications for MRI |
Country | Name | City | State |
---|---|---|---|
Slovenia | Institute of Oncology Ljubljana | Ljubljana |
Lead Sponsor | Collaborator |
---|---|
Institute of Oncology Ljubljana |
Slovenia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | target volume CTV-HR | V100 (%), D90 (%), D98 (%), D100 (%) | at two hours after the end of brachytherapy procedure | |
Secondary | organs at risk | D2cc (Gy), D0.1cc (Gy), Dmax (Gy) | at two hours after the end of brachytherapy procedure |
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