NCT06432478

Brief Summary

Intracavitary brachytherapy for gynaecological cancer currently use cylinder-type applicators or custom wax moulds to place a radioactive source in close proximity to the treatment area and provide highly conformal dose distributions. This study is a Phase IIa non-randomised interventional pilot trial that will investigate the feasibility of successfully treating patients with 3D-printed custom applicators.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
28mo left

Started Nov 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Nov 2023Sep 2028

Study Start

First participant enrolled

November 24, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2024

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 29, 2024

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

4.8 years

First QC Date

January 11, 2024

Last Update Submit

February 4, 2026

Conditions

Vaginal CancerVulva CancerGynecologic CancerEndometrial Cancer

Keywords

3D-printed applicatorGynaecological CancerBrachytherapy

Outcome Measures

Primary Outcomes (1)

  • Successful treatment of gynaecological HDR brachytherapy patients with 3D printed intracavitary applicators.

    To demonstrate the feasibility of successfully simulating, planning and treating a HDR BT gynaecological patient with a 3D-printed internal mould, such that there is a dosimetric and/or clinical benefit for the patient relative to the current standard of care (cylindrical vaginal applicator). Successful treatment indicated by achieving no adverse events or difference to standard of care, and dosimentic comparisons of the 3D printed applicator plan to the cylinder plan are equivalent or better. Feasibility also determined by achieving no logistical or design issues in using the 3D printed applicators clinically.

    5 years

Secondary Outcomes (8)

  • To assess the patients radiation therapy acute and late toxicities using the CTCAE criteria

    5 years

  • To compare quality of treatment plans generated for 3D-printed moulds and cylindrical applicators assessed by dosimetric indices, statistical analysis (p-value) and comparison with international guidelines.

    5 years

  • Determine feasibility of a pre-planned MR-only procedure

    5 years

  • To determine the feasibility of an initial CT-only process by comparing initial and final CT plan dosimetry assessed by dosimetric indices, clinical tolerances, and statistical analysis (p-value).

    5 years

  • Determine feasibility of optimising 3D-printed applicator design based on the cylinder fitting procedure

    5 years

  • +3 more secondary outcomes

Study Arms (1)

Gynaecological HDR brachytherapy patients

EXPERIMENTAL

Using 3D-printed custom applicators to treat gynaecological HDR brachytherapy patients

Device: 3D-printed custom applicator

Interventions

3D-printed custom applicatorDEVICE

3D-printed custom applicator

Gynaecological HDR brachytherapy patients

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to give informed consent
  • Patients indicated for intracavitary brachytherapy
  • FIGO stage I-IVA
  • ECOG 0-2
  • Primary endometrial cancer, primary vaginal cancer, primary vulva cancer, recurrent gynaecological cancer

You may not qualify if:

  • Pregnancy
  • Patients contraindicated for brachytherapy
  • Inflammatory bowel disease/history of adhesions/bowel obstruction
  • Renal transplant/horseshoe kidney
  • Patients with significant LVSI or pelvic sidewall invasion
  • Patients requiring interstitial brachytherapy implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal North Shore Hospital

St Leonards, New South Wales, 2067, Australia

RECRUITING

MeSH Terms

Conditions

Endometrial NeoplasmsVaginal NeoplasmsVulvar Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesVaginal DiseasesVulvar Diseases

Study Officials

  • Marita Morgia, MD

    Royal North Shore Hospital

    PRINCIPAL INVESTIGATOR

  • Jeremy Booth, PhD QMP

    Royal North Shore Hospital

    STUDY DIRECTOR

Central Study Contacts

Marita Morgia, MD

CONTACT

9463 1300Marita.Morgia@health.nsw.gov.au

Jeremy Booth, PhD QMP

CONTACT

94631300jeremy.booth@health.nsw.gov.au

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2024

First Posted

May 29, 2024

Study Start

November 24, 2023

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations

AU(1)