Suspected Prostate Cancer (increased PSA Level)ProstaCESTNCT06669273
Oncological Prognosis of Prostate Lesions by Chemical Exchange Saturation Transfer Magnetic Resonance Imaging (CEST-MRI)
A study testing CEST MRI sequence at 3T in people with Suspected Prostate Cancer (increased PSA Level), run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Suspected Prostate Cancer (increased PSA Level)
- What is being tested?
- CEST MRI sequence at 3T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- Patients will be excluded:
- refusing to participate in the study
- with impaired understanding, under guardianship/curatorship/deprived of liberty
- 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
- during a period of exclusion from another study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de Clermont-Ferrand
Clermont-Ferrand, AURA, 63000
Pascal CHABROT
About this study
Official title: Oncological Prognosis of Prostate Lesions by CEST MRI: Correlation of CEST MRI and Anatomopathological Analysis
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.
Read more
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.
Read the detailed description
This prospective, single-center study will make it possible to evaluate the capabilities of CEST MRI to predict oncological prognosis by comparing it to the reference multiparametric MRI examination and to the anatomopathological analysis of samples taken from biopsies.
When the patient presents a suspicion of prostate cancer identified by an increase in the blood concentration of Prostate Specific Antigen (PSA), he is usually seen in consultation by the urologist within the urology department of the University Hospital. It is during this consultation, after having informed the patient of the need to carry out an MRI to rule out or confirm the presence of a lesion, that the doctor will propose the study to the patient, inform him, and grant him a period of reflection, will answer all his questions and will jointly sign the consent with him if he wishes to participate.
The imaging examination will be carried out a maximum of 6 weeks after the inclusion visit in the research slots of the 3T MRI at CHU Gabriel Montpied (Wednesdays and Fridays). Patients will follow the usual imaging protocol with first multiparametric MRI acquisitions including sequences with injection of contrast product (GADOLINIUM) then a CEST MRI sequence whose duration will not exceed 15 min.
As part of the patient's classic course, if the presence of one or more lesions is proven, a sample of the lesion(s) is taken for an anatomopathological analysis which will give the degree of tumor involvement. The patient returns to the University Hospital approximately 4 weeks later for a consultation for the anatomopathological results and the proposal for subsequent management (monitoring or treatment).
The following data will be noted: age, medical history, PSA level in the blood (nanogram / millilitre), PI-RADS score for each suspicious lesion identified on multiparametric MRI acquisitions, Extension assessment, Parameters measured from the CEST MRI sequence for each of the suspicious lesions: ATP-CEST rate (in arbitrary units), MTRasym, Guanidyl/APT ratio making it possible to assess tumor acidosis, Pathology of samples from the lesion(s): presence or absence of lesions or cancer cells, their number, extent and nature using the Gleason score.
The main objective of this study aims to study the predictive properties of a CEST MRI in the tumor classification of prostate tumors, considering the presence or absence of lesions or cancer cells, their extent and their nature through the score of Gleason on pathological examination of biopsy specimens as dependent variable of interest and measurements on APT-CEST images as main explanatory variable.
False negative rates, diagnostic sensitivity and specificity values and negative and positive predictive values will be presented with a 95% confidence interval.
The concordance between anatomopathological examination and CEST MRI will be studied by estimating the rate of concordant cases and Kappa concordance coefficient.
The usual inferential statistical tests will be considered: for comparisons concerning variables of a quantitative nature: Student's t test or Mann-Whitney test if the conditions for applying the t-test are not respected; for categorical parameters: Chi2 test or Fisher exact test. Particular attention will be paid in particular to the time between the MRI and the pathological examination (3 weeks on average).
- Being tested
- CEST MRI sequence at 3T
- Keywords
- suspected prostate cancer, increased PSA level, CEST-MRI, Guanidyl/APT ratio to assess tumor acidosis,, tumor classification, Gleason score, PI-RADS score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEST MRI sequence at 3TOther
The MRI will be performed at the Clermont Ferrand University Hospital on the 3T research MRI on a Siemens MRI system (MAGNETOM VIDA, Siemens Healthcare, Erlangen, Germany), the emission of the radiofrequency pulses and the reception of the signal will be done using a coil dedicated to the abdo-pelvic region. The images will be analyzed by the radiologist.
MRI is non-irradiating medical imaging. It is practiced according to good practices and the recommendations of the French Society of Radiology.
- Acquisition of morphological T1, T2 sequences for the identification of areas of interest on the pelvic area.
- Acquisition of the CEST MRI sequence (acquisition time 5 min)
- Acquisition of functional sequences, DWI diffusion-weighted images and dynamic DCE sequence after injection of a single dose of non-linear gadolinum.
The imaging report will reveal the presence or absence of tumor lesions in the prostate and their location. Data will then be compared to the histopathological analysis.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : - Label : suspicion of prostate cancer | Experimental | 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 Receives: Other: CEST MRI sequence at 3T |
What is being measured
The primary outcome is the main question the study is designed to answer.
APT-CEST levels to assess tumoral stage
APT-CEST level is measured on the CEST images and is the maximum, among all the lesions, of the quantitative ratio between the APT-CEST measurement on the area with lesion and the same measurement on the healthy area. The results of the CEST MRI will be collected following the analysis of the metabolic images produced using the tools (Matlab scripts), as well as those developed by the medical image analysis platform (OLEA medical).
Measured: Measurement at the experimental visit within 3 months after the inclusion visit.
Guanidyl/APT ratio to assess tumoral acidosis.
Guanidyl/APT ratio is measured on the CEST images and is the maximum, among all the lesions, of the quantitative ratio between the guanidyl/APT ratio measured on the area with lesion and the same measurement on the healthy area. The results of the CEST MRI will be collected following the analysis of the metabolic images produced using the tools (Matlab scripts), as well as those developed by the medical image analysis platform (OLEA medical).
Measured: Measurement at the experimental visit within 3 months after the inclusion visit.
Secondary outcomes (5)
Gleason score
The Gleason score determines the prognosis of prostate cancer based on the architectural structure of the gland. It represent an ordinal score between 2 and 10 depending on the degree of aggressiveness of the cancer.
- Gleason score 6 (3+3): poorly differentiated and not very aggressive tumors;
- Gleason score 7 (3+4 or 4+3): moderately differentiated tumors;
- Gleason score 8, 9 or 10: very undifferentiated and very aggressive tumors.
Measured: Measurement at the experimental visit within 3 months after the inclusion visit
characterization of highly suspicious lesions on MRI
The PI-RADS (Prostate Imaging Reporting and Data System) score is a prognostic score designed to determine the probability of a cancerous origin of an abnormality visible on MRI. For each abnormality visible on MRI, the radiologist classifies the image according to the Pirads score from the least suspicious (Pirads 1) to the most suspicious (Pirads 5).
Measured: Measurement at the experimental visit within 3 months after the inclusion visit.
Magnetization transfer ratio with asymmetric analysis (MTRasym) complementing the APT-CEST ratio
Quantitative ratios between measurement of the magnetization transfer ratio with asymmetric analysis (MTRasym) on the area with lesion and the healthy area: this measurement will be calculated per lesion and per patient (like the maximum measurements per lesion, on the scale of each patient).
Measured: Measurement at the experimental visit within 3 months after the inclusion visit.
Nuclear Overhauser Enhancement (NOE) measured on CEST-MRI
Quantitative ratios between measurement of the Nuclear Overhauser Enhancement (NOE effect) on the area with lesion and the healthy area: this measurement will be calculated per lesion and per patient (like the maximum measurements per lesion, on the scale of each patient).
Measured: Measurement at the experimental visit within 3 months after the inclusion visit.
Prostate-Specific Antigen PSA level in blood
The prostate-specific antigen (PSA) test is a blood test that can help diagnose prostate problems. The amount of PSA in blood is expressed in nanogram/milliliter. A PSA value of greater than or equal to 4.0 ng/mL is the consensus standard for further prostate cancer evaluation.
Measured: Measurement at the experimental visit within 3 months after the inclusion visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study startOct 2024 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suspected Prostate Cancer (increased PSA Level)Studies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal CHABROT, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669273
- Sponsor's protocol ID
- RBHP 2024 CHABROT
- Other IDs
- 2024-A01950-47
- Acronym
- ProstaCEST
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncological Prognosis of Prostate Lesions by CEST MRI: Correlation of CEST MRI and Anatomopathological Analysis
- ClinicalTrials.gov ID
- NCT06669273
- Acronym / sponsor ID
- ProstaCEST / RBHP 2024 CHABROT
- Keywords
- suspected prostate cancer, increased PSA level, CEST-MRI, Guanidyl/APT ratio to assess tumor acidosis,, tumor classification, Gleason score, PI-RADS score
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This prospective, single-center study will make it possible to evaluate the capabilities of CEST MRI to predict oncological prognosis by comparing it to the reference multiparametric MRI examination and to the anatomopathological analysis of samples taken from biopsies.
When the patient presents a suspicion of prostate cancer identified by an increase in the blood concentration of Prostate Specific Antigen (PSA), he is usually seen in consultation by the urologist within the urology department of the University Hospital. It is during this consultation, after having informed the patient of the need to carry out an MRI to rule out or confirm the presence of a lesion, that the doctor will propose the study to the patient, inform him, and grant him a period of reflection, will answer all his questions and will jointly sign the consent with him if he wishes to participate.
The imaging examination will be carried out a maximum of 6 weeks after the inclusion visit in the research slots of the 3T MRI at CHU Gabriel Montpied (Wednesdays and Fridays). Patients will follow the usual imaging protocol with first multiparametric MRI acquisitions including sequences with injection of contrast product (GADOLINIUM) then a CEST MRI sequence whose duration will not exceed 15 min.
As part of the patient's classic course, if the presence of one or more lesions is proven, a sample of the lesion(s) is taken for an anatomopathological analysis which will give the degree of tumor involvement. The patient returns to the University Hospital approximately 4 weeks later for a consultation for the anatomopathological results and the proposal for subsequent management (monitoring or treatment).
The following data will be noted: age, medical history, PSA level in the blood (nanogram / millilitre), PI-RADS score for each suspicious lesion identified on multiparametric MRI acquisitions, Extension assessment, Parameters measured from the CEST MRI sequence for each of the suspicious lesions: ATP-CEST rate (in arbitrary units), MTRasym, Guanidyl/APT ratio making it possible to assess tumor acidosis, Pathology of samples from the lesion(s): presence or absence of lesions or cancer cells, their number, extent and nature using the Gleason score.
The main objective of this study aims to study the predictive properties of a CEST MRI in the tumor classification of prostate tumors, considering the presence or absence of lesions or cancer cells, their extent and their nature through the score of Gleason on pathological examination of biopsy specimens as dependent variable of interest and measurements on APT-CEST images as main explanatory variable.
False negative rates, diagnostic sensitivity and specificity values and negative and positive predictive values will be presented with a 95% confidence interval.
The concordance between anatomopathological examination and CEST MRI will be studied by estimating the rate of concordant cases and Kappa concordance coefficient.
The usual inferential statistical tests will be considered: for comparisons concerning variables of a quantitative nature: Student's t test or Mann-Whitney test if the conditions for applying the t-test are not respected; for categorical parameters: Chi2 test or Fisher exact test. Particular attention will be paid in particular to the time between the MRI and the pathological examination (3 weeks on average).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 : - Label : suspicion of prostate cancer | Experimental | Other: CEST MRI sequence at 3TPatients 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 may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- refusing to participate in the study
- with impaired understanding, under guardianship/curatorship/deprived of liberty
- 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:
- during a period of exclusion from another study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CEST MRI sequence at 3TThe MRI will be performed at the Clermont Ferrand University Hospital on the 3T research MRI on a Siemens MRI system (MAGNETOM VIDA, Siemens Healthcare, Erlangen, Germany), the emission of the radiofrequency pulses and the reception of the signal will be done using a coil dedicated to the abdo-pelvic region. The images will be analyzed by the radiologist. MRI is non-irradiating medical imaging. It is practiced according to good practices and the recommendations of the French Society of Radiology. * Acquisition of morphological T1, T2 sequences for the identification of areas of interest on the pelvic area. * Acquisition of the CEST MRI sequence (acquisition time 5 min) * Acquisition of functional sequences, DWI diffusion-weighted images and dynamic DCE sequence after injection of a single dose of non-linear gadolinum. The imaging report will reveal the presence or absence of tumor lesions in the prostate and their location. Data will then be compared to the histopathological analysis. | Other | Group 1 : - Label : suspicion of prostate cancer |
Primary outcome
APT-CEST levels to assess tumoral stage
Time frame: Measurement at the experimental visit within 3 months after the inclusion visit.
APT-CEST level is measured on the CEST images and is the maximum, among all the lesions, of the quantitative ratio between the APT-CEST measurement on the area with lesion and the same measurement on the healthy area. The results of the CEST MRI will be collected following the analysis of the metabolic images produced using the tools (Matlab scripts), as well as those developed by the medical image analysis platform (OLEA medical).
Guanidyl/APT ratio to assess tumoral acidosis.
Time frame: Measurement at the experimental visit within 3 months after the inclusion visit.
Guanidyl/APT ratio is measured on the CEST images and is the maximum, among all the lesions, of the quantitative ratio between the guanidyl/APT ratio measured on the area with lesion and the same measurement on the healthy area. The results of the CEST MRI will be collected following the analysis of the metabolic images produced using the tools (Matlab scripts), as well as those developed by the medical image analysis platform (OLEA medical).
5 secondary outcomes
Gleason score
Time frame: Measurement at the experimental visit within 3 months after the inclusion visit
characterization of highly suspicious lesions on MRI
Time frame: Measurement at the experimental visit within 3 months after the inclusion visit.
Magnetization transfer ratio with asymmetric analysis (MTRasym) complementing the APT-CEST ratio
Time frame: Measurement at the experimental visit within 3 months after the inclusion visit.
Nuclear Overhauser Enhancement (NOE) measured on CEST-MRI
Time frame: Measurement at the experimental visit within 3 months after the inclusion visit.
Prostate-Specific Antigen PSA level in blood
Time frame: Measurement at the experimental visit within 3 months after the inclusion visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pascal CHABROT principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CEST MRI sequence at 3T in people with Suspected Prostate Cancer (increased PSA Level), run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334-73-754-963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
APT-CEST levels to assess tumoral stage (time frame: Measurement at the experimental visit within 3 months after the inclusion visit.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.