Pancreatic NeoplasmsDFINCT07763561
EUS-DFI in Solid Pancreatic Lesions
An observational study of Pancreatic Neoplasms and Pancreatic Solid Lesions, run by Julio Iglesias García.
Trial summary
This prospective, international, multicenter observational study aims to evaluate the role of Endoscopic Ultrasound-guided Detective Flow Imaging (EUS-DFI) in the characterization of solid pancreatic lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms, Pancreatic Solid Lesions
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 31 Dec 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: Adult patients undergoing routine endoscopic ultrasound (EUS) in participating centers in whom a solid pancreatic lesion is identified and who provide written informed consent.
Who may be able to join
- Adults aged 18 years or older.
- Presence of a solid pancreatic lesion identified during endoscopic ultrasound (EUS), regardless of the indication for the examination.
- Ability and willingness to provide written informed consent.
Who cannot join
- Predominantly cystic pancreatic lesions.
- Anatomical abnormalities preventing adequate EUS examination.
- Limited ability to understand the study procedures or provide informed consent.
- Refusal to sign the informed consent form.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Role of Endoscopic Ultrasound-guided Detective Flow Imaging (EUS-DFI) for the Evaluation of Solid Pancreatic Tumours: A Prospective, International Multicenter Study
This prospective, international, multicenter observational study aims to evaluate the role of Endoscopic Ultrasound-guided Detective Flow Imaging (EUS-DFI) in the characterization of solid pancreatic lesions. The study will assess microvascularization patterns identified by EUS-DFI and their association with the final diagnosis, using histopathology or clinical follow-up as the reference standard. Secondary objectives include evaluating interobserver agreement and the diagnostic accuracy of DFI vascular patterns for differentiating benign and malignant pancreatic lesions.
Read the detailed description
Endoscopic ultrasound (EUS) is an essential technique for the evaluation of pancreatic lesions. However, conventional B-mode imaging alone is often insufficient to accurately differentiate the various types of solid pancreatic tumors, making tissue acquisition necessary in many cases. Despite the high diagnostic accuracy of EUS-guided sampling, false-negative results may occur and repeated sampling can be required.
Detective Flow Imaging (DFI) is a novel ultrasound technology that enables visualization of microvascularization without the use of contrast agents by detecting low-velocity blood flow while minimizing motion artifacts. Preliminary evidence suggests that DFI may improve lesion characterization, but data regarding its application in solid pancreatic lesions remain limited.
This is a prospective, international, multicenter observational study including adult patients undergoing routine EUS in whom a solid pancreatic lesion is identified. All participants will undergo standard EUS evaluation, EUS-guided DFI assessment, and tissue acquisition according to routine clinical practice. DFI findings will be correlated with the final diagnosis established by surgical pathology, EUS-guided tissue sampling, or comprehensive clinical, imaging, and laboratory follow-up of at least six months.
The primary objective is to characterize DFI microvascularization patterns according to the histological diagnosis of solid pancreatic lesions. Secondary objectives include assessing interobserver agreement among investigators and determining the diagnostic performance of DFI vascular patterns for differentiating malignant from benign pancreatic lesions.
- Conditions
- Pancreatic Neoplasms, Pancreatic Solid Lesions
- Medical subject headings
- Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
DFI vascularization pattern
Classification of vascularization pattern as hypovascular, isovascular, hypervascular or indeterminate on DFI.
Measured: At the time of the EUS procedure
Presence of vessels
Presence or absence of vessels identified on DFI.
Measured: At the time of the EUS procedure
Vessel distribution
Classification of vessel distribution as intratumoral or peritumoral on DFI.
Measured: At the time of the EUS procedure
Secondary outcomes (2)
Interobserver agreement for DFI vascular pattern classification
To assess the interobserver agreement among investigators for the classification of DFI vascular patterns.
Measured: Up to 6 months
Diagnostic accuracy of DFI vascular patterns for malignancy
To evaluate the diagnostic accuracy of DFI vascular patterns for differentiating benign and malignant solid pancreatic lesions using the final diagnosis as the reference standard.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pancreatic NeoplasmsStudies 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Julio Iglesias García
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale San Raffaele, Università Vita Salute San Raffaele, Policlinico Universitario Campus Bio-Medico, Leids Universitair Medisch Centrum (LUMC), Leiden
- Responsible party
- Sponsor-investigator, Julio Iglesias García, Hospital Clinico Universitario de Santiago
- Investigators
- Julio Iglesias García, PhD, Principal investigator, Hospital Clínico Universitario de Santiago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763561
- Sponsor's protocol ID
- EUS-DFI 2025/01
- Acronym
- DFI
- Status last verified
- Aug 2026
- First submitted
- 16 Jul 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Individual data sharing
- No
Publications
Miwa H, Sugimori K, Yonei S, Yoshimura H, Endo K, Oishi R, Funaoka A, Tsuchiya H, Kaneko T, Numata K, Maeda S. Differential Diagnosis of Solid Pancreatic Lesions Using Detective Flow Imaging Endoscopic Ultrasonography. Diagnostics (Basel). 2024 Apr 24;14(9):882. doi: 10.3390/diagnostics14090882.
PubMed 38732296Mulqui MV, Caillol F, Ratone JP, Hoibian S, Dahel Y, Meunier E, Archimbaud C, Giovannini M. Detective flow imaging versus contrast-enhanced EUS in solid pancreatic lesions. Endosc Ultrasound. 2024 Jul-Aug;13(4):248-252. doi: 10.1097/eus.0000000000000076. Epub 2024 Aug 23.
PubMed 39318752Yamashita Y, Kitano M. Role of contrast-enhanced harmonic endoscopic ultrasonography (EUS) and EUS elastography in pancreatic lesions. Clin Endosc. 2024 Mar;57(2):164-174. doi: 10.5946/ce.2023.074. Epub 2024 Jan 17.
PubMed 38229442
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Endoscopic Ultrasound-guided Detective Flow Imaging (EUS-DFI) for the Evaluation of Solid Pancreatic Tumours: A Prospective, International Multicenter Study
- ClinicalTrials.gov ID
- NCT07763561
- Acronym / sponsor ID
- DFI / EUS-DFI 2025/01
- Conditions
- Pancreatic Neoplasms, Pancreatic Solid Lesions
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Julio Iglesias GarcíaUniversity, hospital or other
- Collaborators
- Ospedale San Raffaele, Università Vita Salute San Raffaele, Policlinico Universitario Campus Bio-Medico, Leids Universitair Medisch Centrum (LUMC), Leiden
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Aug 2026 (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.
This prospective, international, multicenter observational study aims to evaluate the role of Endoscopic Ultrasound-guided Detective Flow Imaging (EUS-DFI) in the characterization of solid pancreatic lesions. The study will assess microvascularization patterns identified by EUS-DFI and their association with the final diagnosis, using histopathology or clinical follow-up as the reference standard. Secondary objectives include evaluating interobserver agreement and the diagnostic accuracy of DFI vascular patterns for differentiating benign and malignant pancreatic lesions.
Detailed description
Endoscopic ultrasound (EUS) is an essential technique for the evaluation of pancreatic lesions. However, conventional B-mode imaging alone is often insufficient to accurately differentiate the various types of solid pancreatic tumors, making tissue acquisition necessary in many cases. Despite the high diagnostic accuracy of EUS-guided sampling, false-negative results may occur and repeated sampling can be required.
Detective Flow Imaging (DFI) is a novel ultrasound technology that enables visualization of microvascularization without the use of contrast agents by detecting low-velocity blood flow while minimizing motion artifacts. Preliminary evidence suggests that DFI may improve lesion characterization, but data regarding its application in solid pancreatic lesions remain limited.
This is a prospective, international, multicenter observational study including adult patients undergoing routine EUS in whom a solid pancreatic lesion is identified. All participants will undergo standard EUS evaluation, EUS-guided DFI assessment, and tissue acquisition according to routine clinical practice. DFI findings will be correlated with the final diagnosis established by surgical pathology, EUS-guided tissue sampling, or comprehensive clinical, imaging, and laboratory follow-up of at least six months.
The primary objective is to characterize DFI microvascularization patterns according to the histological diagnosis of solid pancreatic lesions. Secondary objectives include assessing interobserver agreement among investigators and determining the diagnostic performance of DFI vascular patterns for differentiating malignant from benign pancreatic lesions.
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
- Adult patients undergoing routine endoscopic ultrasound (EUS) in participating centers in whom a solid pancreatic lesion is identified and who provide written informed consent.
Key inclusion criteria (3 listed)
- Adults aged 18 years or older.
- Presence of a solid pancreatic lesion identified during endoscopic ultrasound (EUS), regardless of the indication for the examination.
- Ability and willingness to provide written informed consent.
Key exclusion criteria (4 listed)
- Predominantly cystic pancreatic lesions.
- Anatomical abnormalities preventing adequate EUS examination.
- Limited ability to understand the study procedures or provide informed consent.
- Refusal to sign the informed consent form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
DFI vascularization pattern
Time frame: At the time of the EUS procedure
Classification of vascularization pattern as hypovascular, isovascular, hypervascular or indeterminate on DFI.
Presence of vessels
Time frame: At the time of the EUS procedure
Presence or absence of vessels identified on DFI.
Vessel distribution
Time frame: At the time of the EUS procedure
Classification of vessel distribution as intratumoral or peritumoral on DFI.
2 secondary outcomes
Interobserver agreement for DFI vascular pattern classification
Time frame: Up to 6 months
Diagnostic accuracy of DFI vascular patterns for malignancy
Time frame: Up to 6 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 13 Aug 2026.
- Background: PubMed 38732296Miwa H, Sugimori K, Yonei S, Yoshimura H, Endo K, Oishi R, Funaoka A, Tsuchiya H, Kaneko T, Numata K, Maeda S. Differential Diagnosis of Solid Pancreatic Lesions Using Detective Flow Imaging Endoscopic Ultrasonography. Diagnostics (Basel). 2024 Apr 24;14(9):882. doi: 10.3390/diagnostics14090882.
- Background: PubMed 39318752Mulqui MV, Caillol F, Ratone JP, Hoibian S, Dahel Y, Meunier E, Archimbaud C, Giovannini M. Detective flow imaging versus contrast-enhanced EUS in solid pancreatic lesions. Endosc Ultrasound. 2024 Jul-Aug;13(4):248-252. doi: 10.1097/eus.0000000000000076. Epub 2024 Aug 23.
- Background: PubMed 38229442Yamashita Y, Kitano M. Role of contrast-enhanced harmonic endoscopic ultrasonography (EUS) and EUS elastography in pancreatic lesions. Clin Endosc. 2024 Mar;57(2):164-174. doi: 10.5946/ce.2023.074. Epub 2024 Jan 17.
- 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.
Julio Iglesias García, PhD principal investigator
Hospital Clínico Universitario de Santiago
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Neoplasms and Pancreatic Solid Lesions, run by Julio Iglesias García.
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 3 inclusion and 4 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 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Julio Iglesias García, PhD (981951364 ext. +34, dig.chus.santiago@sergas.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFI vascularization pattern (time frame: At the time of the EUS procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07763561, which also lists 3 linked publications.
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 13 Aug 2026.