In Vivo Dosimetry for Brachytherapy Study

NCT06863090 | Recruiting

• 1 other identifier: RD2024-15
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer; Gynaecological Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (1)

• Review of investigative and corrective action

  12 months

Study Arms (2)

Prostate cancer patients

histologically proven primary or recurrent prostate cancer

Gynaecological cancer patient

locally advanced gynaecological malignancy in the primary and recurrent setting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• East and North Hertfordshire NHS Trust: lead
• TRUEinvivo Limited: collaborator

Study Sites (1)

Mount Vernon Cancer Centre

Northwood, Middlesex, HA62RN, United Kingdom

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Peter Hoskin

  East and North Hertfordshire NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rishma Bhatti

CONTACT

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

Amani Chowdhury

CONTACT

amani.chowdhury@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: March 3, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Locations

GB (1)