CancerNCT03466957
Individual Approach in Gynecological Cancer Brachytherapy
A study testing Individualized 3D-Printed Brachytherapy Applicator in people with Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Cancer
- What is being tested?
- Individualized 3D-Printed Brachytherapy Applicator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSlovenia
- Study dates
- May 2016to Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- regional or general anesthesia contraindications
- contraindications for MRI
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Individualized 3D-Printed Brachytherapy Applicator
- Keywords
- image guided brachytherapy, 3D print, gynecological cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized 3D-Printed Brachytherapy ApplicatorDevice
Also called individual applicator
An individualized MRI-compatible brachytherapy applicator is designed based on the participant's anatomy, tumor location, high-risk clinical target volume, and preliminary treatment plan. The applicator is manufactured using 3D-printing technology and may include an add-on cap for oblique needles, an individualized Vienna-type applicator, or an individualized vaginal cylinder for intracavitary and interstitial brachytherapy. The aim is to improve target volume coverage while respecting dose constraints for organs at risk.
| Study group | Role | What they receive |
|---|---|---|
| Individualized 3D-Printed Brachytherapy Applicator | Experimental | Participants with gynecological cancer and suboptimal target volume coverage using standard brachytherapy applicators receive MRI-guided brachytherapy using an individually designed 3D-printed applicator. Treatment plans generated with the standard and individualized applicators are compared within the same participant. Receives: Device: Individualized 3D-Printed Brachytherapy Applicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in High-Risk Clinical Target Volume Coverage
Dose-volume parameters for the high-risk clinical target volume (HR-CTV) will be compared between treatment plans generated with a standard brachytherapy applicator and an individualized 3D-printed applicator within the same participant. Evaluated parameters include D90, D98, D100, and V100. The absolute and relative improvement achieved with the individualized applicator will be reported.
Measured: During brachytherapy treatment planning, before delivery of the planned brachytherapy dose
Number of Participants With Grade 3 or Higher Treatment-Related Toxicity
Treatment-related toxicity involving the bladder, rectum, bowel, and vagina will be assessed using the Common Terminology Criteria for Adverse Events, version 3.0. The number and percentage of participants with new or worsening grade 3 or higher toxicity will be reported. Vaginal stenosis will be evaluated separately in accordance with the study protocol.
Measured: From the first brachytherapy procedure through 60 months after completion of treatment
Secondary outcomes (2)
Dose to Organs at Risk
Dose-volume parameters for organs at risk will be compared between treatment plans generated with the standard and individualized 3D-printed applicators. Evaluated organs include the bladder, rectum, sigmoid colon, and small bowel. Parameters include D2cc, D0.1cc, and maximum dose, expressed in gray.
Measured: During brachytherapy treatment planning, before delivery of the planned brachytherapy dose
Local Tumor Control
Local control is defined as the absence of persistent or recurrent disease at the anatomical site of the tumor identified on baseline magnetic resonance imaging. Local control will be assessed by clinical and gynecological examinations and by magnetic resonance imaging. The number and percentage of participants with local control will be reported.
Measured: From completion of treatment through 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study startMay 2016
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants received individualized MRI-guided gynecological brachytherapy using a 3D-printed applicator when standard applicators did not provide adequate target volume coverage. Dose-volume parameters from standard and individualized applicator treatment plans were compared within the same participant.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helena Barbara Zobec Logar, MD, Principal investigator, Brachytherapy Department, Institute of Oncology Ljubljana, Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466957
- Sponsor's protocol ID
- ERID-KESOPKR/63
- Status last verified
- Jul 2026
- First submitted
- 1 Mar 2018
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Assessment of Individual 3D Printed Applicators in MRI Guided Gynecological Brachytherapy
- ClinicalTrials.gov ID
- NCT03466957
- Acronym / sponsor ID
- ERID-KESOPKR/63
- Conditions
- Cancer
- Keywords
- image guided brachytherapy, 3D print, gynecological cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 15 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants received individualized MRI-guided gynecological brachytherapy using a 3D-printed applicator when standard applicators did not provide adequate target volume coverage. Dose-volume parameters from standard and individualized applicator treatment plans were compared within the same participant.
| Arm | Type | Receives |
|---|---|---|
| Individualized 3D-Printed Brachytherapy Applicator | Experimental | Device: Individualized 3D-Printed Brachytherapy ApplicatorParticipants with gynecological cancer and suboptimal target volume coverage using standard brachytherapy applicators receive MRI-guided brachytherapy using an individually designed 3D-printed applicator. Treatment plans generated with the standard and individualized applicators are compared within the same participant. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- regional or general anesthesia contraindications
- contraindications for MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized 3D-Printed Brachytherapy ApplicatorAlso: individual applicatorAn individualized MRI-compatible brachytherapy applicator is designed based on the participant's anatomy, tumor location, high-risk clinical target volume, and preliminary treatment plan. The applicator is manufactured using 3D-printing technology and may include an add-on cap for oblique needles, an individualized Vienna-type applicator, or an individualized vaginal cylinder for intracavitary and interstitial brachytherapy. The aim is to improve target volume coverage while respecting dose constraints for organs at risk. | Device | Individualized 3D-Printed Brachytherapy Applicator |
Primary outcome
Improvement in High-Risk Clinical Target Volume Coverage
Time frame: During brachytherapy treatment planning, before delivery of the planned brachytherapy dose
Dose-volume parameters for the high-risk clinical target volume (HR-CTV) will be compared between treatment plans generated with a standard brachytherapy applicator and an individualized 3D-printed applicator within the same participant. Evaluated parameters include D90, D98, D100, and V100. The absolute and relative improvement achieved with the individualized applicator will be reported.
Number of Participants With Grade 3 or Higher Treatment-Related Toxicity
Time frame: From the first brachytherapy procedure through 60 months after completion of treatment
Treatment-related toxicity involving the bladder, rectum, bowel, and vagina will be assessed using the Common Terminology Criteria for Adverse Events, version 3.0. The number and percentage of participants with new or worsening grade 3 or higher toxicity will be reported. Vaginal stenosis will be evaluated separately in accordance with the study protocol.
2 secondary outcomes
Dose to Organs at Risk
Time frame: During brachytherapy treatment planning, before delivery of the planned brachytherapy dose
Local Tumor Control
Time frame: From completion of treatment through 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helena Barbara Zobec Logar, MD principal investigator
Brachytherapy Department, Institute of Oncology Ljubljana, Slovenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized 3D-Printed Brachytherapy Applicator in people with Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in High-Risk Clinical Target Volume Coverage (time frame: During brachytherapy treatment planning, before delivery of the planned brachytherapy dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.