Clinical trial · Observational
In Vivo Dosimetry for Brachytherapy Study
A Single-centre Feasibility Study Investigating the Use of in Vivo Dosimetry in Patients Receiving High Dose Rate (HDR) Brachytherapy for Gynaecological and Prostate Cancers
NCT06863090CI-TRIAL-00087015recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main study aim is the investigate the clinical use of in vivo dosimeters (small measurement devices) for brachytherapy (internal radiotherapy).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynaecological Cancer | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Prostate cancer patients
- description
- histologically proven primary or recurrent prostate cancer
- label
- Gynaecological cancer patient
- description
- locally advanced gynaecological malignancy in the primary and recurrent setting
Primary outcomes (1)
- measure
- To assess the feasibility of in vivo dosimetry in HDR brachytherapy and compare the calculated dose against measured dose
- timeFrame
- 12 months
- description
- Measured by comparing the calculated (treatment planning system (TPS)) dose against the measured dose (using micro silica thermo-luminescent dosimeters (TLDs) and micro metal oxide field effect transistors (MOSFETS)). The measured dose will be compared to the calculated dose by the TPS at the bladder neck, anterior rectal wall, recto-vaginal point (gynaecological cases) and within the clinical target volume (CTV) for each fraction as well for the whole treatment.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Patients aged 18 years and above
* Patients receiving HDR brachytherapy using iridium-192 (192Ir) radioactive source either as a monotherapy or in combination with external beam radiotherapy for:
1. histologically/radiologically proven primary or locally recurrent prostate cancer
2. locally advanced gynaecological malignancy in the primary and recurrent setting
* primary cervix carcinoma (squamous, adenocarcinoma, adenosquamous) FIGO IB2-IVA
* primary vulval FIGO I-IVA
* primary vaginal FIGO I-IVA
* primary endometrial cancer FIGO Stage I-IVA (not suitable for surgery)
* endometrial cancer receiving adjuvant vaginal vault brachytherapy
* recurrent cervix, vulval, vaginal or endometrial cancer suitable for brachytherapy as discussed in a regional gynae-oncology multidisciplinary meeting.
* World Health Organisation (WHO) or Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Exclusion Criteria:
* Previous brachytherapy exposure to the treatment site
* Patients unable to give informed consent
* Patients unable to have a regional or general anaesthetic
* Patients with the following medical conditions: coagulopathies, history of another primary malignancy, known allergy or sensitivity to study materials; previous or current fistulae
* Not able to understand the implications of participating in the study in English
* Patients with recent (within the last 6 months) or currently participating in interventional researchReferences
Publications (0)
Data not yet available
No reference posted for this study.