Pancreatic Ductal AdenocarcinomaPROCLAIMNCT07252076
PRetreatment MRI for OCcult Liver Metastasis Assessment In Pancreatic Ductal adenocarcinoMa
An observational study of Pancreatic Ductal Adenocarcinoma, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
Trial summary
Pancreatic cancer has a low survival rate largely due to late diagnosis and undetected liver metastases. Computed tomography (CT), the standard diagnostic tool, often misses occult metastases that are later discovered during surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Contrast-enhanced MRI and DWI sequences
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 17 Jul 2025to 17 Jan 2027
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have received a histopathological diagnosis of pancreatic ductal adenocarcinoma and have undergone contrast-enhanced CT without evidence of metastatic disease, defined as the presence of suspicious lesions in the liver, lungs, distant lymph nodes, peritoneum, or other organs.
Who may be able to join
- Male or female patients over 18 years of age.
- Patients with a new cytological or histological diagnosis of PDAC.
- A CT scan demonstrating pancreatic disease and meeting the minimum criteria for the imaging assessment of pancreatic gland tumors (see section 4.6, study procedures).
- An MRI performed no later than 3 weeks after the CT scan, also meeting the minimum radiological criteria (see section 4.6, study procedures).
- No prior treatment for pancreatic disease.
- Patients able to receive and understand the study information and to provide written informed consent duly signed by both the patient and the investigator.
Who cannot join
- Signs of metastatic disease on the initial CT scan (hepatic, pulmonary, distant lymph node, peritoneal carcinomatosis, or other organ involvement).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
SC Chirurgia Generale
Alessandria, Piedmont, 15121
SC Chirurgia Generale, 0131206893, fabio.giannone@ospedale.al.it
About this study
Official title: PRetreatment MRI for OCcult Liver Metastasis Assessment In Pancreatic Ductal adenocarcinoMa. An International Multicentric, Prospective, Diagnostic Accuracy Trial
Pancreatic cancer has a low survival rate largely due to late diagnosis and undetected liver metastases. Computed tomography (CT), the standard diagnostic tool, often misses occult metastases that are later discovered during surgery. Recent studies suggest that magnetic resonance imaging (MRI), especially with diffusion-weighted imaging (DWI), can better detect very small liver metastases and help avoid unnecessary surgery. However, MRI is not yet widely used in routine practice due to limited evidence and its selective application. This study proposes incorporating contrast-enhanced MRI and DWI into the diagnostic workflow to improve diagnostic accuracy and guide more effective treatment decisions for patients with pancreatic cancer.
Read the detailed description
Pancreatic cancer (PC) is a deadly disease with a low five-year survival rate, mainly due to late diagnosis and distant metastases, particularly to the liver. Computed tomography (CT) is the conventional diagnostic method, but it does not always detect hidden liver metastases, which are often only identified during surgery. Recent studies suggest that the use of magnetic resonance imaging (MRI), especially with diffusion-weighted imaging (DWI) sequences, could improve the detection of occult liver metastases, even those smaller than one centimeter, and thus influence treatment decisions, reducing unnecessary surgery.
However, the adoption of MRI as standard practice is not yet widespread, due to the lack of evidence and its limited use in specific situations. This study proposes integrating contrast-enhanced MRI and DWI into the diagnostic protocol to refine diagnostic accuracy and therapeutic choices, with the aim of optimizing treatment and survival in patients with pancreatic cancer.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- Contrast-enhanced MRI and DWI sequences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-enhanced MRI and DWI sequencesRadiation
Assessment of the accuracy of contrast-enhanced MRI and DWI sequences in detecting liver metastases in PDAC that are not identified on CT and evaluation of the clinical impact of adding this imaging modality to the diagnostic algorithm in this specific patient population.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients
Percentage of patients in whom MEOs will be detected on MRI in the intention-to-image population after negative CT for secondary lesions.
Measured: Through study completion, an average of 18 months
Secondary outcomes (1)
Identification of the target sequences
Identification of the most accurate sequences for detecting MEOs on MRI
Measured: Through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start17 Jul 2025
- Primary completion17 Dec 2026 (estimated)
- Study completion17 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252076
- Sponsor's protocol ID
- ASO.ChirGen.25.03
- Acronym
- PROCLAIM
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRetreatment MRI for OCcult Liver Metastasis Assessment In Pancreatic Ductal adenocarcinoMa. An International Multicentric, Prospective, Diagnostic Accuracy Trial
- ClinicalTrials.gov ID
- NCT07252076
- Acronym / sponsor ID
- PROCLAIM / ASO.ChirGen.25.03
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di AlessandriaUniversity, hospital or other
- Study start
- 17 Jul 2025 (actual)
- Primary completion
- 17 Dec 2026 (estimated)
- Study completion
- 17 Jan 2027 (estimated)
- First posted
- 26 Nov 2025 (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.
Pancreatic cancer has a low survival rate largely due to late diagnosis and undetected liver metastases. Computed tomography (CT), the standard diagnostic tool, often misses occult metastases that are later discovered during surgery. Recent studies suggest that magnetic resonance imaging (MRI), especially with diffusion-weighted imaging (DWI), can better detect very small liver metastases and help avoid unnecessary surgery. However, MRI is not yet widely used in routine practice due to limited evidence and its selective application. This study proposes incorporating contrast-enhanced MRI and DWI into the diagnostic workflow to improve diagnostic accuracy and guide more effective treatment decisions for patients with pancreatic cancer.
Detailed description
Pancreatic cancer (PC) is a deadly disease with a low five-year survival rate, mainly due to late diagnosis and distant metastases, particularly to the liver. Computed tomography (CT) is the conventional diagnostic method, but it does not always detect hidden liver metastases, which are often only identified during surgery. Recent studies suggest that the use of magnetic resonance imaging (MRI), especially with diffusion-weighted imaging (DWI) sequences, could improve the detection of occult liver metastases, even those smaller than one centimeter, and thus influence treatment decisions, reducing unnecessary surgery.
However, the adoption of MRI as standard practice is not yet widespread, due to the lack of evidence and its limited use in specific situations. This study proposes integrating contrast-enhanced MRI and DWI into the diagnostic protocol to refine diagnostic accuracy and therapeutic choices, with the aim of optimizing treatment and survival in patients with pancreatic cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have received a histopathological diagnosis of pancreatic ductal adenocarcinoma and have undergone contrast-enhanced CT without evidence of metastatic disease, defined as the presence of suspicious lesions in the liver, lungs, distant lymph nodes, peritoneum, or other organs.
Key inclusion criteria (6 listed)
- Male or female patients over 18 years of age.
- Patients with a new cytological or histological diagnosis of PDAC.
- A CT scan demonstrating pancreatic disease and meeting the minimum criteria for the imaging assessment of pancreatic gland tumors (see section 4.6, study procedures).
- An MRI performed no later than 3 weeks after the CT scan, also meeting the minimum radiological criteria (see section 4.6, study procedures).
- No prior treatment for pancreatic disease.
Key exclusion criteria (1 listed)
- Signs of metastatic disease on the initial CT scan (hepatic, pulmonary, distant lymph node, peritoneal carcinomatosis, or other organ involvement).
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 |
|---|---|---|
| Contrast-enhanced MRI and DWI sequencesAssessment of the accuracy of contrast-enhanced MRI and DWI sequences in detecting liver metastases in PDAC that are not identified on CT and evaluation of the clinical impact of adding this imaging modality to the diagnostic algorithm in this specific patient population. | Radiation | – |
Primary outcome
Percentage of patients
Time frame: Through study completion, an average of 18 months
Percentage of patients in whom MEOs will be detected on MRI in the intention-to-image population after negative CT for secondary lesions.
1 secondary outcome
Identification of the target sequences
Time frame: Through study completion, an average of 18 months
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 26 Nov 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Ductal Adenocarcinoma, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
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 6 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 26 Nov 2025. 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 Italy. 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 Clinical Trial Center Clinical Trial Center (0131206893, clinicaltrialcenter@ospedale.al.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients (time frame: Through study completion, an average of 18 months). 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 26 Nov 2025.