## Protocol Section
### Identification Module
**NCT ID:** NCT06432478

**Brief Title:** 3D Printed Custom Applicators for HDR BT (DISCO)

**Official Title:** Study of 3D-printed Custom Applicators for Intracavitary HDR Gynaecological Brachytherapy (DISCO)

#### Organization Study ID Info
**ID:** DISCO
#### Organization
**Class:** OTHER
**Full Name:** Royal North Shore Hospital
### Status Module
#### Completion Date
**Date:** 2028-09

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2028-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-11-24

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-11
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Royal North Shore Hospital

#### Responsible Party

**Investigator Affiliation:** Royal North Shore Hospital

**Investigator Full Name:** Marita Morgia

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

**Detailed Description:** 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. Current workflows for designing and constructing custom applicators with wax moulds are complex, time consuming and can result in a device that fails to meet original design specifications dictated by the planning system. In contrast, 3D-printed custom applicators provide the ability to design and print patient-specific devices that match optimal design specifications. The workflow for 3D-printed applicators is also more efficient with lower turn-around time and labour/equipment costs, and ensures a more robust product for treatment. Despite these advantages there is currently no radiotherapy department offering 3D printed custom applicators at present. This study will investigate the feasibility of successfully treating gynaecological cancers with 3D-printed custom applicators.

### Conditions Module

**Conditions:**

- Gynecologic Cancer

- Endometrial Cancer

- Vaginal Cancer

- Vulva Cancer

**Keywords:**

- 3D-printed applicator

- Gynaecological Cancer

- Brachytherapy

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 10

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Device: 3D-printed custom applicator

**Label:** Gynaecological HDR brachytherapy patients

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Gynaecological HDR brachytherapy patients

**Description:** 3D-printed custom applicator

**Name:** 3D-printed custom applicator

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Successful treatment of gynaecological HDR brachytherapy patients with 3D printed intracavitary applicators.

**Time Frame:** 5 years

#### Secondary Outcomes

**Description:** RT acute and late side effects will be assessed and quantified using CTCAE criteria via clinician assessment and PROs

**Measure:** To assess the patients radiation therapy acute and late toxicities using the CTCAE criteria

**Time Frame:** 5 years

**Description:** The plan quality of treatment plans generated for 3D-printed moulds and cylindrical applicators will be compared using dosimetric indices including target coverage (D90, Dose Homogeneity index) and organs at risk doses (D2cc, D1cc and point max) as well as patient comfort. statistical analysis (p-value) and comparison with international guidelines will be used to assess the quality of the treatment plans.

**Measure:** 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.

**Time Frame:** 5 years

**Description:** Feasibility of a pre-planned MR-only procedure will be determined using any of the patients that are accrued to the study who have both a CT and MRI performed at the time of simulation. The applicator and treatment plan will be generated based on the MRI and both compared to the CT-based plan and applicator. Feasibility will be indicated by generating equivalent plan quality and applicators from both methods.

**Measure:** Determine feasibility of a pre-planned MR-only procedure

**Time Frame:** 5 years

**Description:** The initial and final CT plan dosimetry will be compared to determine the feasibility of an initial CT-only process. Clinically insignificant differences between the plan dosimetry metrics and all within clinical tolerances will be used to quantify the difference. statistical analysis (p-value) will be used to assess the quality of the treatment plans.

**Measure:** 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).

**Time Frame:** 5 years

**Description:** The feasibility of an optimised 3D-printed applicator design based on the cylinder fitting procedure will be assessed by comparison of the 3D-printed clinical applicators with applicators derived from CT/MR of the vault in a relaxed state with an expansion applied based on the size of the cylinder applied in the fitting procedure. Feasibility will be determined by looking for a correlation between the size of the 3D printed clinical applicators and the size of the cylinders tolerated by the patient in the fitting procedure.

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

**Time Frame:** 5 years

**Description:** Procedure times will be recorded as per ARIA carepath tasks and time taken within the 3D-printed custom applicator workflow compared to the standard of care cylinder applicator workflow with equivalent or less time taken deemed acceptable

**Measure:** To measure resources such as procedure times and demonstrate acceptable timescales for the process

**Time Frame:** 5 years

**Description:** Costs associated with the 3D-printed design process will be defined and compared with the standard of care process via economic analysis of the resourcing and unit-price estimates in each arm of the respective workflows

**Measure:** To define the resource costs associated with the 3D-printed design process and perform a cost comparison with the standard of care process

**Time Frame:** 5 years

**Description:** Patient experience and acceptability of the 3D-printed simulation and treatment processes will be assessed with the EORTC QLQ-C30 questionnaires and success measured by comparison with the standard of care vaginal cylinder process. Questionnaires include questions with a scale of 1-4 where a higher number indicates a worse experience and a scale of 1-7 where a lower number indicates a worse experience.

**Measure:** To assess patient experience and acceptability of the process with questionnaires

**Time Frame:** 5 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Marita.Morgia@health.nsw.gov.au

**Name:** Marita Morgia, MD

**Phone:** 9463 1300

**Role:** CONTACT

**Contact 2:**

**Email:** jeremy.booth@health.nsw.gov.au

**Name:** Jeremy Booth, PhD QMP

**Phone:** 94631300

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** St Leonards

**Contacts:**

***Contact 1:***

- **Email:** Carolyn.Kwong@health.nsw.gov.au

- **Name:** Carol Kwong

- **Phone:** 02 9463 1339

- **Role:** CONTACT

***Contact 2:***

- **Email:** Heidi.Tsang@health.nsw.gov.au

- **Name:** Heidi Tsang

- **Phone:** 02 9463 1340

- **Role:** CONTACT

**Country:** Australia

**Facility:** Royal North Shore Hospital

**State:** New South Wales

**Status:** RECRUITING

**Zip:** 2067

#### Overall Officials

**Official 1:**

**Affiliation:** Royal North Shore Hospital

**Name:** Marita Morgia, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Royal North Shore Hospital

**Name:** Jeremy Booth, PhD QMP

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014594

- Term: Uterine Neoplasms

- ID: D000005833

- Term: Genital Neoplasms, Female

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000014591

- Term: Uterine Diseases

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000091662

- Term: Genital Diseases

- ID: D000014623

- Term: Vaginal Diseases

- ID: D000014845

- Term: Vulvar Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M17373

- Name: Vaginal Neoplasms

- Relevance: HIGH

- As Found: Vaginal Cancer

- ID: M17589

- Name: Vulvar Neoplasms

- Relevance: HIGH

- As Found: Vulva Cancer

- ID: M19235

- Name: Endometrial Neoplasms

- Relevance: HIGH

- As Found: Endometrial Cancer

- ID: M17342

- Name: Uterine Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8945

- Name: Genital Neoplasms, Female

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M17339

- Name: Uterine Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M17371

- Name: Vaginal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17588

- Name: Vulvar Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T5829

- Name: Vaginal Cancer

- Relevance: HIGH

- As Found: Vaginal Cancer

- ID: T5877

- Name: Vulvar Cancer

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000016889

- Term: Endometrial Neoplasms

- ID: D000014625

- Term: Vaginal Neoplasms

- ID: D000014846

- Term: Vulvar Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
