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NCT Number: NCT06863090

In Vivo Dosimetry for Brachytherapy Study

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mount Vernon Cancer Centre

Northwood, Middlesex, HA62RN, United Kingdom

Location status: Recruiting

Location contact

Peter Hoskin

PRINCIPAL_INVESTIGATOR

Rishma Bhatti

CONTACT

[email protected]

02038262075

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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 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

Treatment and study plan

Primary outcomes

  1. To assess the feasibility of in vivo dosimetry in HDR brachytherapy and compare the calculated dose against measured dose

    Time frame: 12 months

    Measured by comparing the calculated (treatment planning system (TPS)) dose against the measured dose (using micro silica thermo-luminescent dosimeters (TLDs) and micro metal oxide field effect transistors (MOSFETS)). The measured dose will be compared to the calculated dose by the TPS at the bladder neck, anterior rectal wall, recto-vaginal point (gynaecological cases) and within the clinical target volume (CTV) for each fraction as well for the whole treatment.

Secondary outcomes

  1. Review of investigative and corrective action

    Time frame: 12 months

    Measured by defined action thresholds during high-dose rate (HDR) brachytherapy

Study contacts

Contact information is provided by the study sponsor or research team.

Amani Chowdhury

CONTACT

[email protected]

Rishma Bhatti

CONTACT

mvccresearch/[email protected]

0203 826 2020

Sponsors and collaborators

Lead sponsor

East and North Hertfordshire NHS Trust

Other Gov

Collaborators

  • TRUEinvivo Limited

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 7, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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