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In Vivo Dosimetry for Brachytherapy Study

Sponsor: East and North Hertfordshire NHS Trust

NCT ID: NCT06863090

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 12 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at prostate cancer and gynaecological (women's reproductive) cancers. It involves patients having a type of internal radiotherapy called high-dose-rate (HDR) brachytherapy, which uses a radioactive source called iridium-192. The study is checking the dose of radiation delivered during this treatment, a process called in vivo dosimetry. It is sponsored by East and North Hertfordshire NHS Trust.

Who can take part

  • Adults aged 18 or over
  • Having high-dose-rate (HDR) brachytherapy with an iridium-192 radioactive source, either on its own or with external beam radiotherapy
  • Have prostate cancer that is proven by tissue or scan tests, either first-time or locally recurrent
  • Have a locally advanced gynaecological cancer, either new or recurrent, of a listed type and stage (for example cervix, vulval, vaginal or endometrial cancer)
  • Be well enough overall (performance status of 0 to 2 on the WHO or ECOG scales)

Who may not be able to

  • Have had brachytherapy to the same part of the body before
  • Unable to give informed consent
  • Unable to have a regional or general anaesthetic
  • Have a blood-clotting condition, another primary cancer, an allergy or sensitivity to study materials, or a fistula (now or in the past)
  • Cannot understand what taking part means in English
  • Have taken part in interventional research in the last 6 months or are taking part now

What taking part involves

  • • High-dose-rate (HDR) brachytherapy using an iridium-192 radioactive source, either alone or combined with external beam radiotherapy
  • • Measurements of the radiation dose delivered during treatment (in vivo dosimetry)

Time commitment: Number of visits and study duration: Not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
20
Started
2025-03-03
Last checked
2025-03

Plain English Summary

What is this study?

  • • Testing a new treatment for prostate cancer
  • • Clinical study - 20 participants
  • • The main study aim is the investigate the clinical use of in vivo dosimeters (small measurement devices) for brachytherapy (internal radiotherapy)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with prostate cancer

Where?

  • • Northwood - Mount Vernon Cancer Centre

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

More detail

A dosimeter is a small device that is able to record the dose of radiation received. It can provide an independent check that the dose of radiation delivered matches the dose calculated for patients receiving radiotherapy as part of their cancer treatment. The purpose of this study is to investigate the clinical use of in vivo dosimeters for brachytherapy. Two types of dosimeters will be used; micro metal oxide field effect transistors (microMOSFETs) and Thermoluminescent detectors (TLDs). These will be placed into the rectum (back passage), urethra (the tube through which urine leave the body from the bladder) and within or near (typically within a few centimetres) to the cancer itself. These devices will record the dose of radiation received at the time of brachytherapy at each of these sites and we will compare that measurement with the expected measurement based on the calculations we made in planning the patient's treatment.

Prostate CancerGynaecological Cancer

How this trial compares with your answers

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What we know so far

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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Patients aged 18 years and above
  • ✓Patients receiving HDR brachytherapy using iridium-192 (192Ir) radioactive source either as a monotherapy or in...
  • ✓histologically/radiologically proven primary or locally recurrent prostate cancer
  • ✓that has grown locally gynaecological cancer in the primary and recurrent setting
  • ✓primary cervix carcinoma (squamous, adenocarcinoma, adenosquamous) FIGO IB2-IVA

Who cannot take part

  • ✗Previous brachytherapy exposure to the treatment site
  • ✗Patients unable to give agreement to take part
  • ✗Patients unable to have a regional or general anaesthetic
  • ✗Patients with the following medical conditions: coagulopathies, history of another primary cancer, known allergy...
  • ✗Not able to understand the implications of participating in the study in English
See the full 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 Is This Study? (1 UK site)

Mount Vernon Cancer Centre

Northwood HA62RN, United Kingdom

Recruiting
Site contact (verified)
Peter HoskinPrincipal Investigator

How to Get in Touch

Rishma Bhatti

Sponsor contact

CONTACT

0203 826 2020 mvccresearch/enh-tr@nhs.net

Amani Chowdhury

Sponsor contact

CONTACT

amani.chowdhury@nhs.net
Data sourced from ClinicalTrials.gov · Last verified: 2025-03