A robotic MRI-compatible brachytherapy implantation device was developed to perform needle insertion under real-time MRI guidance. The purpose of this study is to investigate the technical feasibility of inserting a brachytherapy needle into the…
ID
Bron
Verkorte titel
Aandoening
Prostate cancer, brachytherapy, robotic device
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To investigate the technical feasibility of using a robotic needle-implant device, which will be determined by the needle-to-tumour-target distance.
Achtergrond van het onderzoek
For patients with localized radiorecurrent prostate cancer, focal treatment has the potential to maintain cancer control with less treatment-related toxicity than whole-gland salvage treatments. High-dose-rate brachytherapy (HDR-BT) is a suitable modality for focal salvage treatment. For brachytherapy needle insertion, the prostate is directly visualised using trans-rectal ultrasound, whereas the target tumour volume is visualised indirectly through delineations from a pre-radiation MRI scan which are fused with the TRUS images. This is a shortcoming in the current workflow, because it requires registration of pre-operative MR-images to live intra-operative TRUS images. This registration becomes less accurate during needle implantation as the firm prostate tissue is displaced and deformed due to edema. However, since space is limited within the MRI bore itself, manual brachytherapy needle insertion under real-time MRI guidance is physically impossible.
To overcome this, a robotic MRI-compatible implantation device was developed to perform focal salvage HDR-BT under direct MRI-guidance. The robot fits in a 1.5T MRI scanner and can be placed between the patient’s legs. The accuracy of the device was tested in air and in an agar phantom, with promising results regarding needle alignment. We anticipate that the tested image-based workflow is also feasible for in vivo validation of the robotic device.
Prior to the standard manual implantation procedure, a single needle will be introduced into the prostate by the robot and a radiation dose will be delivered.
Doel van het onderzoek
A robotic MRI-compatible brachytherapy implantation device was developed to perform needle insertion under real-time MRI guidance. The purpose of this study is to investigate the technical feasibility of inserting a brachytherapy needle into the prostate to a defined tumour target point using this robotic device. With promising results regarding needle alignment after testing in phantoms, it is expected that this will be feasible in vivo as well.
Onderzoeksopzet
4 weeks (assessment of treatment toxicity)
Onderzoeksproduct en/of interventie
Single-needle insertion into the prostate by an MR-compatible robotic device, prior to the conventional manual focal salvage high-dose-rate brachytherapy procedure.
Publiek
J.R.N. Voort van Zyp, van der
Utrecht 3508 GA
The Netherlands
+31 (0)88 7558800
J.R.N.vanderVoortvanZyp@umcutrecht.nl
Wetenschappelijk
J.R.N. Voort van Zyp, van der
Utrecht 3508 GA
The Netherlands
+31 (0)88 7558800
J.R.N.vanderVoortvanZyp@umcutrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Age at least 18 years;
- Biochemical recurrence according to the RTOG-ASTRO Phoenix definition (PSA >2 ng/ml above nadir) at least 2 years after primary treatment;
- Stage T3b tumour or lower;
- Recurrent lesion visible on 68Ga-PSMA-PET-CT and at least 1 sequence of the mp-MRI (T2 weighted (T2W), DCE or DWI);
- Karnofsky score at least 70;
- Prior prostate cancer treatment with standard external beam radiation therapy (EBRT), for which fiducial gold markers were placed in the prostate;
- Tumour location technically feasible for robotic needle placement as determined on diagnostic MRI scan and PET-CT scan;
- Written informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Metastatic disease;
- Other prostate cancer treatments in the past (HIFU or cryosurgery), except for radiotherapy;
- Trans-urethral resection of the prostate (TURP) within the past 6 months;
- Prior radiotherapy for a malignancy in the pelvic area, other than prostate cancer;
- Continuously required anticoagulant administration, except for platelet aggregation inhibitors (for example Ascal/Persantin);
- Hypofractionated EBRT as primary prostate cancer treatment;
- Less than 3 gold markers visible in the prostate on the pre-treatment MRI-scan;
- Physical inability to spread the legs sufficiently for positioning in the leg supports;
- Contra-indications for MRI.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL7482 |
NTR-old | NTR7724 |
Ander register | METC UMC Utrecht : METC 18-643 |