Prostate CancerNCT06863090
In Vivo Dosimetry for Brachytherapy Study
An observational study of Prostate Cancer and Gynaecological Cancer, run by East and North Hertfordshire NHS Trust at 1 site in United Kingdom.
Trial summary
The main study aim is the investigate the clinical use of in vivo dosimeters (small measurement devices) for brachytherapy (internal radiotherapy). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Gynaecological Cancer
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Mar 2025to 1 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving high dose rate (HDR) brachytherapy for gynaecological and prostate cancers
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Amani Chowdhury contact
United Kingdom1 site, 1 recruiting
- Recruiting
Mount Vernon Cancer Centre
Northwood, Middlesex, HA62RN
Rishma Bhatti, 02038262075, mvccresearch.enh-tr@nhs.net
Peter Hoskin
About this study
Official 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
The main study aim is the investigate the clinical use of in vivo dosimeters (small measurement devices) for brachytherapy (internal radiotherapy).
Read the 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.
- Conditions
- Prostate Cancer, Gynaecological Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
To assess the feasibility of in vivo dosimetry in HDR brachytherapy and compare the calculated dose against measured dose
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.
Measured: 12 months
Secondary outcomes (1)
Review of investigative and corrective action
Measured by defined action thresholds during high-dose rate (HDR) brachytherapy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start3 Mar 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East and North Hertfordshire NHS Trust
- Sponsor type
- Other government
- Collaborators
- TRUEinvivo Limited
- Responsible party
- Sponsor
- Investigators
- Peter Hoskin, Principal investigator, East and North Hertfordshire NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863090
- Sponsor's protocol ID
- RD2024-15
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The research results will be published in international journals and presented at scientific meetings.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06863090
- Acronym / sponsor ID
- RD2024-15
- Conditions
- Prostate Cancer, Gynaecological Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- East and North Hertfordshire NHS TrustOther government
- Collaborators
- TRUEinvivo Limited
- Study start
- 3 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main study aim is the investigate the clinical use of in vivo dosimeters (small measurement devices) for brachytherapy (internal radiotherapy).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prostate cancer patients | – | –histologically proven primary or recurrent prostate cancer |
| Gynaecological cancer patient | – | –locally advanced gynaecological malignancy in the primary and recurrent setting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving high dose rate (HDR) brachytherapy for gynaecological and prostate cancers
Key inclusion criteria (11 listed)
- 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:
- World Health Organisation (WHO) or Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Review of investigative and corrective action
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: Undecided. The research results will be published in international journals and presented at scientific meetings.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amani Chowdhury contact
Peter Hoskin principal investigator
East and North Hertfordshire NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Gynaecological Cancer, run by East and North Hertfordshire NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rishma Bhatti (0203 826 2020, mvccresearch/enh-tr@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the feasibility of in vivo dosimetry in HDR brachytherapy and compare the calculated dose against measured dose (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.