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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03466957 |
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Date of registration:
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01/03/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Individual Approach in Gynecological Cancer Brachytherapy
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Scientific title:
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Development and Assessment of Individual 3D Printed Applicators in MRI Guided Gynecological Brachytherapy |
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Date of first enrolment:
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May 2016 |
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Target sample size:
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13 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT03466957 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Slovenia
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Contacts
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Name:
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Helena Barbara Zobec Logar, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Brachytherapy Department, Institute of Oncology Ljubljana, Slovenia |
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Name:
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Helena Barbara Zobec Logar, MD |
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Address:
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Telephone:
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0038615879204 |
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Email:
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hlogar@onko-i.si |
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Affiliation:
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Name:
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Violeta Kaluza |
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Address:
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Telephone:
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0038115879122 |
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Email:
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vkaluza@onko-i.si |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Cancer
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Intervention(s)
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Other: 3D printed applicator
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Primary Outcome(s)
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target volume CTV-HR
[Time Frame: at two hours after the end of brachytherapy procedure]
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Secondary Outcome(s)
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organs at risk
[Time Frame: at two hours after the end of brachytherapy procedure]
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Secondary ID(s)
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ERID-KESOPKR/63
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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