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MRI scan tests a new way to read prostate lesions

Tests a special MRI scan to assess suspected prostate cancer in men.

Key facts

Who runs it
University Hospital, Clermont-Ferrand
Where
Clermont-Ferrand, FranceSee the site
Trial code
Registry title
Oncological Prognosis of Prostate Lesions by Chemical Exchange Saturation Transfer Magnetic Resonance Imaging (CEST-MRI)
Status
Not yet recruiting
People taking part
70 people, planned
Started
Oct 2024
Expected to end
Dec 2027
Type of study
Interventional
Treatments tested
  • CEST MRI sequence at 3T
Record updated
1 November 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men over 18 who may have prostate cancer because their blood PSA level is raised. They have not yet had chemotherapy, radiotherapy or hormone therapy.

Age
Over 18 years; the record lists an upper age limit of 75 years.
Sex
Men only.
Disease stage
Suspected prostate cancer, shown by a raised blood PSA level.
Earlier treatment
Must not have had chemotherapy, radiotherapy or hormone therapy before.
Biomarker or test result
Raised blood PSA concentration.

Main reasons for not taking part

  • Metal parts in the body, such as a pacemaker, neurostimulator, cochlear implant or prostheses
  • Claustrophobia or obesity
  • Past allergy to gadolinium or to gadoteric acid or meglumine contrast agents
  • Impaired understanding, or under guardianship or curatorship, or deprived of liberty
  • Taking part in another study at the same time

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • Patients will be included:
  • aged over 18
  • with suspected prostate cancer identified by an increase in blood PSA concentration
  • naïve to chemotherapy, radiotherapy or hormonal therapy
  • affiliated to a Social Security system
  • able to give informed consent to participate in research
  • understanding and reading French well

Who cannot take part

  • presenting "contraindications" to an MRI examination (with administration of a gadolinium chelate): presence of metal parts in the body (electronic devices such as a cardiac pacemaker, a neurostimulator, a cochlear implant, prostheses, intra foreign bodies ocular…), claustrophobia, obesity
  • at risk:; . history of allergy to gadolinium (contrast product necessary for performing the multiparmatric MRI planned in the routine care pathway; . history of hypersensitivity to gadoteric acid or gadoline contrast agents, meglumine
  • Patients will be excluded:
  • refusing to participate in the study
  • with impaired understanding, under guardianship/curatorship/deprived of liberty
  • during a period of exclusion from another study

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in France

  • CHU de Clermont-FerrandClermont-Ferrand, FranceContact: Pascal CHABROTNo longer taking part

About the trial

What the trial wants to find out

Prostate cancer is the second most common type of cancer in men only after lung cancer, and accounts for ~3.8% of all deaths caused in men in 2018. Multiparametric MRI, which combines anatomical MRI sequences (T2-weighted acquisitions) and functional sequences (DWI Diffusion-Weighted Imaging or dynamic contrast-enhanced (DCE) acquisitions), constitutes a key tool in the detection and monitoring of the therapeutic response in the context of the management of this prostate cancer. In this context, a recognized radiological consensus has been established in order to standardize MRI acquisition protocols and the data processing scheme (Prostate Imaging Reporting and Data System, PI-RADS protocol).

Read full original descriptionShow less

Although the improvement provided by multiparametric MRI is significant for the detection of prostate cancer in the clinic, approximately one third of cases remain equivocal. There is therefore a clear clinical advantage in having additional information to support the diagnosis by discriminating between low-grade, intermediate-grade and high-grade tumors and thus reduce the need for biopsies. CEST (chemical exchange saturation transfer) MRI is a promising molecular imaging tool for specifically detecting metabolites containing exchangeable protons present on amide, amine or even hydroxyl functions. MRI-CEST allows non-invasively to highlight molecules of interest such as lactate, glutamate, citrate and other mobile proteins and peptides involved in the carcinogenesis process and usually impossible to visualize by MRI or MRS (Magnetic Resonance Spectroscopy). Exchangeable protons also have the property of seeing their exchange rates modified depending on the surrounding pH, making this CEST contrast sensitive to pH variations. Then, it is APT-CEST (Amide Proton Transfer CEST). The first efforts to translate this method from the preclinical to the clinic were made for brain imaging of gliomas with a significant contribution of APT-CEST in the stratification of tumors. Now, work is expanding to the imaging of other types of tumors such as pelvic tumors, digestive tumors or even breast or lung cancer. Currently, only a few studies have explored CEST MRI in prostate cancer with several limitations both in terms of data acquisition strategy and signal processing. The expertise of the preclinical component of the IVIA platform (In vivo Imaging Auvergne) will make it possible to remove these obstacles and highlight the interest of CEST MRI for the diagnosis and identification of the tumor stage. Thus, the addition of CEST-MRI to the multiparametric MRI strategy will complete the morphological and functional analysis with metabolic criteria that can be decisive in guiding the diagnosis.

The main objective of this study is to study the relationship between the APT-CEST parameter measured in CEST MRI and the gold standard given by the Gleason score (from the anatomopathological analysis of prostate biopsies), these two data being established for each patient.

Secondary objectives are:

* To study the association between all the CEST MRI parameters (APT-CEST, and magnetization transfer ratio with asymmetric analysis (MTRasym) measurements, Guanidyl/APT ratio, Nuclear Overhauser Enhancement (NOE) signal) and:

* The Gleason score * The PI-RADS score, calculated from the readings taken for each of the suspicious lesions identified on multiparametric MRI (T2-weighted anatomical acquisitions and diffusion-weighted DWI or dynamic DCE acquisitions); * The measurement of the blood prostate-specific antigen (PSA) level; * The volume of the prostate, determined on the anatomical MRI images. * To situate the predictive potential of CEST measurements in relation to other variables a priori associated with the Gleason score.

The group in the trial

  • Group 1 : - Label : suspicion of prostate cancerTreatment being tested

    Patients will be included: * aged over 18 * with suspected prostate cancer identified by an increase in blood PSA concentration * naïve to chemotherapy, radiotherapy or hormonal therapy * affiliated to a Social Security system * able to give informed consent to participate in research * understanding and reading French well

    Treatment: CEST MRI sequence at 3T

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Oncological Prognosis of Prostate Lesions by CEST MRI: Correlation of CEST MRI and Anatomopathological Analysis
Plain-language title
MRI scan tests a new way to read prostate lesionsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06669273, who can take part
Record updated
1 November 2024