In Vivo Dosimetry for Brachytherapy Study

Recruiting · NCT06863090 · Observational (researchers observe without assigning treatment) · Lead sponsor: East and North Hertfordshire NHS Trust

What this trial is about

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

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not specified

Study type

Observational (researchers observe without assigning treatment)

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:
histologically/radiologically proven primary or locally recurrent prostate cancer
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

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

1 location listed.