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SmartTarget THERAPY

13. november 2014 opdateret af: University College, London

SmartTarget - A Magnetic Resonance Image to Ultrasound Fusion System for Targeted Prostate Intervention: Therapy

The purpose of this study is to assess how accurately SmartTarget can direct high intensity focused ultrasound (HIFU) to a pre-defined area (cancer) in the prostate.

The current standard methods for treating prostate cancer are directed to the whole gland - either surgery to remove it or radiotherapy. An alternative method is focal therapy. This is surgery that uses an energy source to ablate the cancer whilst preserving the normal healthy tissue.

Prior to surgery prostate cancer can often be localised using MRI imaging and detailed prostate biopsy techniques. The difficulty is that during surgery it is very difficult to accurately locate the cancer on the live ultrasound images - to compensate surgeons will treat half or a quarter of the prostate to ensure that the cancer is treated. This may cause higher rates of side-effects.

SmartTarget is an MRI to ultrasound fusion device that maps the pre-treatment MRI onto the live ultrasound during surgery. It then provides a target for the surgeons to treat during the operation.

The results will measure if the area intended to treat was covered and if how accurate the treatment was by comparing the pre-treatment MRI with a 1 week post treatment scan

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

69

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

  1. Histological diagnosis of prostate cancer (PSA </=15ng/ml, Gleason score </=4+3, and radiological stage </=T3aNoMo)
  2. Prostate biopsy concordant with mpMRI lesion (template transperineal or MRI-targeted biopsy only)
  3. Discrete lesion on mpMRI scoring 3, 4 or 5 on radiological scale of suspicion
  4. mpMRI carried out according to European Society of Uro-Radiology guidelines at 1.5T or 3T
  5. An understanding of the English language sufficient to understand written and verbal information about the trial and consent process
  6. Signed informed consent

Exclusion Criteria:

  1. No lesion on mpMRI
  2. Bilateral lesions on mpMRI
  3. mpMRI undertaken over 6 months prior to visit 1
  4. Contralateral Gleason >/=3+4 and/or Maximum Cancer Core Length Involvement >/=6mm
  5. Men who have taken any form of hormones (except 5-alpha reductase inhibitors) within the last 6 months
  6. Prior immunosuppression or predefined immunosuppressed state
  7. An irreversible coagulopathy predisposing to bleeding
  8. Unable to undergo transrectal ultrasonography
  9. Previous radiation therapy to the pelvis
  10. Previous HIFU, cryosurgery, thermal, irreversible electroporation, radiofrequency or microwave therapy to the prostate.
  11. Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging
  12. Men not fit for major surgery as assessed by a consultant anaesthetist
  13. Men who are unable to give informed consent

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Target Ablation
Tidsramme: 1 week post treatment
The ability of SmartTarget-directed focal HIFU therapy to ablate an intended target within the prostate, as measured by the proportion of men in whom complete ablation of the target region is achieved. Complete or incomplete ablation is determined by a comparative assessment of the pre-therapy and one week post-therapy contrast-enhanced MRIs by an expert radiologist.
1 week post treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Accuracy
Tidsramme: 1 week post treatment
The accuracy of SmartTarget guided focal HIFU measured by the relative treatment volume and relative ablation volume on the one week post treatment.
1 week post treatment
Length of the procedure
Tidsramme: intraoperative

The efficiency and clinical usability of the SmartTarget device as measured by the:

Length of the procedure

The time taken during the procedure using SmartTarget, including:

The total prostate computer model generation time The total time taken to register (fuse) MRI and ultrasound image data and the number of times an image registration is performed using SmartTarget (the re-registration rate) SmartTarget failure rate
intraoperative
Quality of Life
Tidsramme: 6 weeks and 3 months

To assess how this treqatment strategy impacts on quality of life as measured using validated questionnaires at 6 weeks and 3 months post treatment.

IPSS IIEF EQ5D - 5L
6 weeks and 3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University College, London

Efterforskere

  • Ledende efterforsker: Hashim U Ahmed, FRCS PhD, University College, London

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2014

Primær færdiggørelse (Forventet)

1. oktober 2015

Studieafslutning (Forventet)

1. oktober 2015

Datoer for studieregistrering

Først indsendt

10. november 2014

Først indsendt, der opfyldte QC-kriterier

13. november 2014

Først opslået (Skøn)

14. november 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. november 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. november 2014

Sidst verificeret

1. november 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 14/0389

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Prostatiske neoplasmer

Kliniske forsøg med MR

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Sponsorer og samarbejdspartnere

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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