In Vivo Dosimetry for Brachytherapy Study

ConditionsProstate Cancer Gynaecological Cancer

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorEast and North Hertfordshire NHS Trust

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18 years and above

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

20 Participants

are grouped into 2 trial groups

Group A: Prostate cancer patients

Group B: Gynaecological cancer patient

Trial outcomes

Primary outcomes

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.

Time frame

12 months

Secondary outcomes

Review of investigative and corrective action

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

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

East and North Hertfordshire NHS Trust

Lead sponsor

TRUEinvivo Limited

Collaborator

Source ClinicalTrials.gov

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