Clinical feasibility of a MRI guided robotic system for implantation of position verification markers in the prostate prior to radiotherapy.

Clinical feasibility of a MRI guided robotic system for implantation of position verification markers in the prostate prior to radiotherapy. - Clnical feasibility of a MRI guided robotic implant system.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31479

Enrollment

Registered

2008-07-08

Start date

2009-06-03

Completion date

Unknown

Last updated

2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer prostate carcinoma

Interventions

20 patients will receive three gold markers by the robotic MRI-guided implant system.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Presence of biopsy proven prostate carcinoma and indication for external beam radiotherapy and therefore gold marker implantation (tumour stadium T1-2N0M0 and no possibilities for brachytherapy or tumour stadium T3N0M0, plus a sufficient physical condition defined as a Karnofsky score >70 percent).

Exclusion criteria

Exclusion criteria: - Contra-indication for MR imaging (following the UMCU Radiology protocol, see also page 13 of the study protocol) - Claustrophobia - Artificial hip replacement - Contra-indication for gold marker implantation: Use of anti-coagulants which cannot be stopped prior to intervention, prostate intervention in history (transurethral resection of the prostate) or infection, fistula or wounds in the perineal area.

Design outcomes

Primary

Measure	Time frame
We consider this intervention feasible if none of the patients suffer from grade 3 toxicity or more as a consequence of the intervention (as defined by the Common Toxicity Criteria Version 3.0 (CTC) for a selection of categories). In addition, a decrease in quality of life (QoL) score (following Rand-36, QLQ-C30 and QLQ-PR25 questionnaires) not more than mean 10 points from baseline for the total group, is considered to be acceptable. Pain will be evaluated using the visual-analogic scale (VAS).	—

Measure

Time frame

We consider this intervention feasible if none of the patients suffer from grade 3 toxicity or more as a consequence of the intervention (as defined by the Common Toxicity Criteria Version 3.0 (CTC) for a selection of categories). In addition, a decrease in quality of life (QoL) score (following Rand-36, QLQ-C30 and QLQ-PR25 questionnaires) not more than mean 10 points from baseline for the total group, is considered to be acceptable. Pain will be evaluated using the visual-analogic scale (VAS).

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Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)