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In Vivo Dosimetry for Brachytherapy Study

RECRUITINGSponsored by East and North Hertfordshire NHS Trust
Actively Recruiting
SponsorEast and North Hertfordshire NHS Trust
Started2025-03-03
Est. completion2026-03-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06863090

Summary

The main study aim is the investigate the clinical use of in vivo dosimeters (small measurement devices) for brachytherapy (internal radiotherapy).

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions3

CancerGynaecological CancerProstate Cancer

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