Individual Approach in Gynecological Cancer Brachytherapy

March 14, 2018 updated by: Institute of Oncology Ljubljana

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients with locoregionally gynecological cancers will be included in this single-institution, non-randomized, one-arm study. All patients will receive 45-50 Gy external beam radiotherapy (EBRT) with intensity-modulated radiotherapy/volumetric-modulated arc therapy (IMRT/VMAT) technique, 1.8-2 Gy/fraction +/- concurrent cisplatin based chemotherapy. First BT with commercially available standard applicators (tandem with ring +/- parallel needles or vaginal cylinder) will be carried out. MRI with applicator in situ will be performed, high-risk clinical target volume (CTV-HR) and organs at risk (OAR) will be delineated and treatment planning will be conducted. In the case of large gynecological cancer and suboptimal target coverage at BT (V100 ≤ 90%, D98 ≤ 80%, D90 ≤ 100%, D100 ≤ 60%) a preplan will be performed as the basis for the 3D applicator modelling. The next BT application will be performed with an individually designed 3D printed applicator. Dose-volume characteristics of the following treatment plans will be compared: the preplan, the plan with standard and the plan with individual 3D printed applicator.

The primary objective of the study is to determine the improvement of dose-volume parameters with the use of 3D printed individual applicators in advanced gynecological cancer.

Study Type

Interventional

Enrollment (Anticipated)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Recruiting
        • Institute of Oncology Ljubljana
        • Contact:
        • Principal Investigator:
          • Helena Barbara Zobec Logar, MD
        • Sub-Investigator:
          • Barbara Šegedin, MD
        • Sub-Investigator:
          • Robert Hudej, physicist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 3D printed applicator
individually designed applicator for BT
Other: 3D printed applicator
add-on cap for oblique needles, 3D printed Vienna-like applicator, individual vaginal cylinder for intracavitary/interstitial application
Other Names:
  • individual applicator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
target volume CTV-HR
Time Frame: at two hours after the end of brachytherapy procedure
V100 (%), D90 (%), D98 (%), D100 (%)
at two hours after the end of brachytherapy procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
organs at risk
Time Frame: at two hours after the end of brachytherapy procedure
D2cc (Gy), D0.1cc (Gy), Dmax (Gy)
at two hours after the end of brachytherapy procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Oncology Ljubljana

Investigators

  • Principal Investigator: Helena Barbara Zobec Logar, MD, Brachytherapy Department, Institute of Oncology Ljubljana, Slovenia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2016

Primary Completion (ANTICIPATED)

May 1, 2018

Study Completion (ANTICIPATED)

January 1, 2019

Study Registration Dates

First Submitted

March 1, 2018

First Submitted That Met QC Criteria

March 14, 2018

First Posted (ACTUAL)

March 15, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 15, 2018

Last Update Submitted That Met QC Criteria

March 14, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ERID-KESOPKR/63

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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