In Vivo Dosimetry for Brachytherapy Study

March 7, 2025 updated by: East and North Hertfordshire NHS Trust

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

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

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Middlesex
      • Northwood, Middlesex, United Kingdom, HA62RN
        • Recruiting
        • Mount Vernon Cancer Centre
        • Contact:
        • Contact:
          • Peter Hoskin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients receiving high dose rate (HDR) brachytherapy for gynaecological and prostate cancers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Prostate cancer patients
histologically proven primary or recurrent prostate cancer
Gynaecological cancer patient
locally advanced gynaecological malignancy in the primary and recurrent setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Review of investigative and corrective action
Time Frame: 12 months
Measured by defined action thresholds during high-dose rate (HDR) brachytherapy
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

East and North Hertfordshire NHS Trust

Collaborators

TRUEinvivo Limited

Investigators

  • Principal Investigator: Peter Hoskin, East and North Hertfordshire NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 3, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 7, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD2024-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The research results will be published in international journals and presented at scientific meetings.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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