Lymph NodesLymph/EUS/01NCT04671784
Endoscopic Ultrasound Elastography (Strain Ratio) and Fractal-based Quantitative Analysis for the Mediastinal and Abdominal Lymphadenopathies
An observational study of Lymph Nodes, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Endoscopic ultrasound (EUS) and EUS-guided tissue acquisition (EUS-TA) are minimally invasive techniques to establish the benign or malignant nature of lymph nodes (LNs) with a very high accuracy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymph Nodes
- What is being tested?
- EUS-E
- How many people
- 101 participants
- Where
- 1 siteItaly
- Study dates
- 27 Sep 2019to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Consecutive patients with enlarged mediastinal or abdominal lymph nodes detected by cross-sectional imaging and confirmed at EUS will be enrolled.
Who may be able to join
- patients with identified enlarged lymph nodes;
- patients >18 years old.
Who cannot join
- patients who decline to participate in the study
- patients with contraindication to the procedure
Trial locations and contacts
1 site in 1 country.
About this study
Endoscopic ultrasound (EUS) and EUS-guided tissue acquisition (EUS-TA) are minimally invasive techniques to establish the benign or malignant nature of lymph nodes (LNs) with a very high accuracy. In particular, for mediastinal LNs, a meta-analysis underlined that EUS features alone are not enough to reach a good sensitivity and specificity, while EUS-TA showed a slightly high sensitivity (88% vs. 85%) and a significantly high specificity (96% vs. 85%) for diagnosing the cause of LN enlargement. Considering all sites, according to the meta-analysis of Xu and colleagues, the assessment of LNs by EUS-elastography is a useful tool in differentiating benign and malignant LNs, with a sensitivity of 88% and a specificity of 85%.
For lymphadenopathy of unknown origin, ESGE recommends performing EUS-TA (or alternatively endobronchial ultrasound [EBUS]-guided) if the patient management requires a pathological result and no superficial lymphadenopathy is easily accessible. Unfortunately, EUS-TA may sometimes be challenging or inconclusive, due to blood contamination or insufficient material.
Read more
EUS elastography (EUS-E) is a non-invasive ultrasound technique that measures the hardness of tissues. The level of hardness of region of interest (ROI) can be evaluated using qualitative scores and/or quantitative methods (strain ratio; SR).
To date, most of the studies on EUS-E have been carried out using the Hitachi ultrasound machine. In particular, Paterson performed a quantitative analysis considering as a pathological value cut-off, the SR ≥7.5 for EUS-E in the nodal staging of esophageal cancer. The study involved 53 LNs using cytology as gold standard: their data showed that EUS-E had a sensitivity of 83%, specificity of 96%, PPV of 95% and NPV of 86%.
Recently, a new compact ultrasound processor, EU-ME2 (Olympus SE \& CO. KG, Hamburg, Germany) that includes an elastography software was developed although data regarding its application in LNs evaluation are still not available. The concept of fractal geometry as a tool for describing natural objects was originally introduced by Benoit Mandelbrot. A fractal can be considered as an irregularly shaped object and that can be divided into fragments, each of them representing a self-similar reduced copy of the whole. The hun body is an example of natural fractal, as many of its parts are characterized by features resembling the typical fractal nature. It has been demonstrated that fractal geometry can be used to efficiently evaluate the geometrical complexity of imaging patterns observed in oncology.
The investigators recently published a study on the role of EUS elastography and fractal based analysis in the differentiation of solid pancreatic lesions. However, data regarding the application of fractal analysis to evaluate lymphadenopathies are still not available.
- Conditions
- Lymph Nodes
- Being tested
- EUS-E
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-EOther
EUS-E
| Study group | Role | What they receive |
|---|---|---|
| Enlarged mediastinal or abdominal | Consecutive patients with enlarged mediastinal or abdominal detected by cross-sectional imaging and confirmed at EUS will be enrolled. Receives: Other: EUS-E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of quantitative EUS-E (strain ratio)
The primary aim of this study is to evaluate the accuracy of quantitative EUS-E (strain ratio) for the diagnosis of malignancy in enlarged lymph nodes.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start27 Sep 2019
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymph NodesStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671784
- Sponsor's protocol ID
- 2364
- Acronym
- Lymph/EUS/01
- Status last verified
- Jul 2025
- First submitted
- 7 Dec 2020
- Last updated
- 30 Jul 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 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound Elastography (Strain Ratio) and Fractal-based Quantitative Analysis for the Mediastinal and Abdominal Lymphadenopathies
- ClinicalTrials.gov ID
- NCT04671784
- Acronym / sponsor ID
- Lymph/EUS/01 / 2364
- Conditions
- Lymph Nodes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 17 Dec 2020 (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.
Endoscopic ultrasound (EUS) and EUS-guided tissue acquisition (EUS-TA) are minimally invasive techniques to establish the benign or malignant nature of lymph nodes (LNs) with a very high accuracy. In particular, for mediastinal LNs, a meta-analysis underlined that EUS features alone are not enough to reach a good sensitivity and specificity, while EUS-TA showed a slightly high sensitivity (88% vs. 85%) and a significantly high specificity (96% vs. 85%) for diagnosing the cause of LN enlargement. Considering all sites, according to the meta-analysis of Xu and colleagues, the assessment of LNs by EUS-elastography is a useful tool in differentiating benign and malignant LNs, with a sensitivity of 88% and a specificity of 85%.
For lymphadenopathy of unknown origin, ESGE recommends performing EUS-TA (or alternatively endobronchial ultrasound [EBUS]-guided) if the patient management requires a pathological result and no superficial lymphadenopathy is easily accessible. Unfortunately, EUS-TA may sometimes be challenging or inconclusive, due to blood contamination or insufficient material.
EUS elastography (EUS-E) is a non-invasive ultrasound technique that measures the hardness of tissues. The level of hardness of region of interest (ROI) can be evaluated using qualitative scores and/or quantitative methods (strain ratio; SR).
To date, most of the studies on EUS-E have been carried out using the Hitachi ultrasound machine. In particular, Paterson performed a quantitative analysis considering as a pathological value cut-off, the SR ≥7.5 for EUS-E in the nodal staging of esophageal cancer. The study involved 53 LNs using cytology as gold standard: their data showed that EUS-E had a sensitivity of 83%, specificity of 96%, PPV of 95% and NPV of 86%.
Recently, a new compact ultrasound processor, EU-ME2 (Olympus SE \& CO. KG, Hamburg, Germany) that includes an elastography software was developed although data regarding its application in LNs evaluation are still not available. The concept of fractal geometry as a tool for describing natural objects was originally introduced by Benoit Mandelbrot. A fractal can be considered as an irregularly shaped object and that can be divided into fragments, each of them representing a self-similar reduced copy of the whole. The hun body is an example of natural fractal, as many of its parts are characterized by features resembling the typical fractal nature. It has been demonstrated that fractal geometry can be used to efficiently evaluate the geometrical complexity of imaging patterns observed in oncology.
The investigators recently published a study on the role of EUS elastography and fractal based analysis in the differentiation of solid pancreatic lesions. However, data regarding the application of fractal analysis to evaluate lymphadenopathies are still not available.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enlarged mediastinal or abdominal | – | Other: EUS-EConsecutive patients with enlarged mediastinal or abdominal detected by cross-sectional imaging and confirmed at EUS will be enrolled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with enlarged mediastinal or abdominal lymph nodes detected by cross-sectional imaging and confirmed at EUS will be enrolled.
Key inclusion criteria (2 listed)
- patients with identified enlarged lymph nodes;
- patients >18 years old.
Key exclusion criteria (2 listed)
- patients who decline to participate in the study
- patients with contraindication to the procedure
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 |
|---|---|---|
| EUS-EEUS-E | Other | Enlarged mediastinal or abdominal |
Primary outcome
Accuracy of quantitative EUS-E (strain ratio)
Time frame: 24 Months
The primary aim of this study is to evaluate the accuracy of quantitative EUS-E (strain ratio) for the diagnosis of malignancy in enlarged lymph nodes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Lymph Nodes, run by Istituto Clinico Humanitas 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 30 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of quantitative EUS-E (strain ratio) (time frame: 24 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 30 Jul 2025.