Using small devices to measure radiation dose during brachytherapy for cancer treatment
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
This study is testing small devices that measure radiation during brachytherapy to see if they can help ensure patients with prostate and gynecological cancers receive the right amount of treatment safely.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | East and North Hertfordshire NHS Trust Government |
| Drugs / interventions | radiation |
| Locations | 1 site (Northwood, Middlesex) |
| Trial ID | NCT06863090 on ClinicalTrials.gov |
What this trial studies
This study investigates the clinical application of in vivo dosimeters, which are small devices that measure the radiation dose received by patients undergoing brachytherapy for prostate and gynecological cancers. The dosimeters, including micro metal oxide field effect transistors (microMOSFETs) and thermoluminescent detectors (TLDs), will be placed in specific anatomical locations to record the actual radiation dose during treatment. The recorded measurements will be compared to the planned doses to ensure accuracy and safety in radiation delivery. This observational study aims to enhance the precision of brachytherapy treatments.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with specific types of prostate or gynecological cancers receiving HDR brachytherapy.
Not a fit: Patients who have previously undergone brachytherapy or those with performance status above ECOG 2 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of radiation delivery in brachytherapy, leading to better treatment outcomes for cancer patients.
How similar studies have performed: Other studies using in vivo dosimetry in brachytherapy have shown promising results, indicating that this approach is both relevant and potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 research
Where this trial is running
Northwood, Middlesex
- Mount Vernon Cancer Centre — Northwood, Middlesex, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Peter Hoskin — East and North Hertfordshire NHS Trust
- Study coordinator: Rishma Bhatti
- Email: mvccresearch/enh-tr@nhs.net
- Phone: 0203 826 2020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.