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CEST for Prostate Biopsy

19. august 2026 opdateret af: Sunnybrook Health Sciences Centre

Advanced Metabolic MRI to Refine Targeted Prostate Biopsy

Samples of prostate tissue acquired by biopsy to determine whether there is cancer will sometimes not find cancer that is present. Conventionally, magnetic resonance imaging (MRI) is used to identify 12 areas to biopsy. We will use an advanced MRI method called magnetization transfer (MT) and chemical exchange saturation transfer (CEST) imaging to suggest two additional biopsy location. Our objectives are to determine 1) whether MT/CEST MRI can aid in the detection prostate cancer and 2) whether MT/CEST MRI can aid conventional MRI in risk stratification and to decide whether targeted prostate biopsy is justified.

Studieoversigt

Status

Ikke rekrutterer endnu

Detaljeret beskrivelse

Prostate Imaging and Data Reporting System assessment categories positively correlate with an increased likelihood of detecting clinically significant prostate cancer (csPCa) at targeted biopsy1. A PI-RADS assessment category 3 (intermediate, clinically significant cancer likelihood equivocal) lesion is often not csPCa. Studies evaluating the likelihood of csPCa cancer at targeted biopsy of PI-RADS category 3 lesions have reported variable rates of PCa diagnosis, ranging from 5-30%, with the majority of studies showing a relatively low likelihood of eventual csPCa diagnosis2-4. Management of PI-RADS category 3 lesion is variable, ranging from immediate biopsy to surveillance5,6. Given the disparity in management patterns for PI-RADS category 3 lesions and a small but not insignificant proportion of these lesions harboring csPCa, better classification of category 3 lesion is an unmet need. Previous studies in these patients have shown a correlation of csPCa with older patient age, smaller prostate volumes, higher prostate-specific antigen density (PSAD), and increased clinical stage7-11.

In this study, we will investigate the ability of magnetization transfer (MT) and chemical exchange saturation transfer (CEST) magnetic resonance imaging (MRI), without the use of any injected contrast agent, in conjunction with multiparametric magnetic resonance imaging (mpMRI) to aid in the detection of cancer, risk stratification and to decide whether a targeted prostate biopsy is justified. In this study, we propose to use the following ST-MRI techniques:

  1. Chemical Exchange Saturation Transfer (CEST) to probe changes in tumour metabolism.
  2. Magnetization Transfer (MT) to evaluate tumour environment microstructure.

Up to five healthy volunteers will be recruited for ST-MRI testing and estimation of test/re-test reproducibility. Testing of MR imaging protocols on healthy volunteers (without contrast agent) is required for optimization of sequence parameters including: higher signal intensity, higher contrast between tissue types, decreased scan time, and reduced image artifacts. There will be up to three MRI scans per healthy volunteer. MRI contrast agent will not be injected.

Patient recruitment will be performed at the Odette Cancer Centre. There will be one MRI scan per patient. All patients will undergo ST-MRI scans at Sunnybrook. ST-MRI parameter images including MTR, AREX, and quantitative MT model parameters, in addition to quantitative magnetization relaxation images will be used to identify areas of prostate with altered image contrast. Other quantitative and semiquantitative features will also be evaluated from the images. We hypothesize that ST-MRI will identify cancer suspicious areas that overlap with those identified by mpMRI and potentially additional areas.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiesteder

    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
        • Ledende efterforsker:
          • Greg J Stanisz, PhD
        • Ledende efterforsker:
          • Christopher Lim, MD
        • Ledende efterforsker:
          • Danny Vesprini, MSc, MD
        • Ledende efterforsker:
          • Stanley K Liu, MD, PhD

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • PI-RADS category 3 prostate cancer with upcoming targeted biopsy

Exclusion Criteria:

  • Contraindications to MRI
  • Prior radiotherapy
  • Prior chemotherapy
  • Prior prostate biopsy

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Diagnostic Test: Saturation Transfer (ST)-MRI
Non-contrast magnetic resonance imaging "Saturation Transfer" scans consisting of magnetization transfer (MT) and chemical exchange saturation transfer (CEST)
Saturation transfer MRI (chemical exchange saturation transfer and magnetization transfer) used to identify two additional biopsy locations in addition to those identified by conventional MRI.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Aiding the detection of prostate cancer
Tidsramme: 1 year
To determine whether MT/CEST MRI can aid in the detection of prostate cancer. The histopathological detection of cancer in biopsy cores will serve as a measure of outcome to which the MT/CEST MRI parameter and relaxation images will be compared.
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Aiding risk stratification and the decision whether targeted prostate biopsy is justified
Tidsramme: 1 year
To determine whether MT/CEST MRI can aid multiparametric MRI (mpMRI) in risk stratification and to decide whether targeted prostate biopsy is justified. The presence of cancer detected histopathologically in biopsy locations suggested by MT/CEST MRI, but not chosen for biopsy by convention mpMRI will serve as a measure of outcome.
1 year

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Greg J Stanisz, PhD, Sunnybrook Research Institute
  • Ledende efterforsker: Christopher Lim, MD, Sunnybrook Health Sciences Centre
  • Ledende efterforsker: Danny Vesprini, MSc, MD, Sunnybrook Health Sciences Centre
  • Ledende efterforsker: Stanley K Liu, MD, PhD, Sunnybrook Health Sciences Centre

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 (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. september 2027

Studieafslutning (Anslået)

1. september 2027

Datoer for studieregistrering

Først indsendt

19. august 2026

Først indsendt, der opfyldte QC-kriterier

19. august 2026

Først opslået (Faktiske)

25. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

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