RecruitingNCT06863090
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
Sponsor
East and North Hertfordshire NHS Trust
Enrollment
20 participants
Start Date
Mar 3, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
The main study aim is the investigate the clinical use of in vivo dosimeters (small measurement devices) for brachytherapy (internal radiotherapy).
Eligibility
Min Age: 18 Years
Inclusion Criteria11
- 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
Exclusion Criteria6
- 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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06863090
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