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CEST for Prostate Biopsy

Advanced Metabolic MRI to Refine Targeted Prostate Biopsy

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07785024
Enrollment
20
Registered
2026-08-25
Start date
2026-09-01
Completion date
2027-09-01
Last updated
2026-08-25

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

Conditions

Prostate Cancer Detection

Keywords

biopsy, MRI, saturation transfer, PI-RADS, chemical exchange saturation transfer, magnetization transfer

Brief summary

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.

Detailed description

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.

Interventions

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.

Sponsors

Sunnybrook Health Sciences Centre
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Aiding the detection of prostate cancer1 yearTo 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.

Secondary

MeasureTime frameDescription
Aiding risk stratification and the decision whether targeted prostate biopsy is justified1 yearTo 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.

Countries

Canada

Contacts

CONTACTGreg J Stanisz, PhD
greg.stanisz@utoronto.ca416-480-5725
PRINCIPAL_INVESTIGATORGreg J Stanisz, PhD

Sunnybrook Research Institute

PRINCIPAL_INVESTIGATORChristopher Lim, MD

Sunnybrook Health Sciences Centre

PRINCIPAL_INVESTIGATORDanny Vesprini, MSc, MD

Sunnybrook Health Sciences Centre

PRINCIPAL_INVESTIGATORStanley K Liu, MD, PhD

Sunnybrook Health Sciences Centre

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 26, 2026