NCT06669273Not yet recruiting
Oncological Prognosis of Prostate Lesions by Chemical Exchange Saturation Transfer Magnetic Resonance Imaging (CEST-MRI)
Oncological Prognosis of Prostate Lesions by CEST MRI: Correlation of CEST MRI and Anatomopathological Analysis
Source: ClinicalTrials.gov · Last updated 1 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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). 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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 21 Oct 2024
- Start date
- Oct 2024
- Primary completion date
- Jun 2027
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Diseases
- Prostate cancer
- NCT number
- NCT06669273
What you commit to
- Study type: Interventional
- Planned participants: 70
- From Oct 2024 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.