LymphadenopathyNCT04743583
Prevalence and Malignant Involvement of Calcified Intrathoracic Lymph Nodes in Patients Undergoing Endosonography
An observational study of Lymphadenopathy and Lung Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The presence of calcifications, which is a relatively common feature in intrathoracic lymph nodes, typically contributes to confer them a heterogeneous aspect during endosonographic B-mode examination, but their prevalence and a possible association between calcifications and metastatic involvement has never been… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lymphadenopathy, Lung Cancer, Sarcoidosis
- What is being tested?
- Endosonography B-mode examination
- Type of treatment
- Medical device
- How many people
- 362 participants
- Where
- 1 siteItaly
- Study dates
- 20 Mar 2021to 31 Dec 2022
- 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 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients with known or suspected lung cancer or other intrathoracic malignancy with indication to endosonography for diagnosis or staging of intrathoracic lymph nodes according to currently accepted international guidelines
Who may be able to join
- Age >18 years at the time of the procedure
- Known or suspected lung cancer or other intrathoracic malignancy based on imaging (CT and/or PET/CT)
- Endosonography (EBUS and/or EUS) indicated for intrathoracic lymph node assessment/sampling according to national and international guidelines: 1) enlarged (> 1 cm on its short axis at CT) and/or PET positive lymph node; and/or 2) conditions at risk for occult mediastinal metastases, such as: i) central primary tumor; ii) primary tumor > 3 cm; iii) PET negative primary tumor; iv) ipsilateral hilar metastasis (cN1 status).
Who cannot join
- Inability or unwillingness to consent
- Compromised upper airway (i.e., concomitant head and neck cancer with upper airway obstruction; critical central airway obstruction from any cause)
- Contraindication for temporary interruption of the use of antiplatelet (excluded aspirin) or anticoagulant drugs
- American Society of Anesthesiologists grade 4
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Intrathoracic Lymph Node Calcifications and Metastatic Involvement in Patients Undergoing Endosonography for Diagnosis and/or Mediastinal Staging of Intrathoracic Malignancy: a Cross-sectional Pilot Study
The presence of calcifications, which is a relatively common feature in intrathoracic lymph nodes, typically contributes to confer them a heterogeneous aspect during endosonographic B-mode examination, but their prevalence and a possible association between calcifications and metastatic involvement has never been systematically evaluated. We hypothesize that, in patients undergoing mediastinal diagnosis or staging of suspected/known lung cancer/intrathoracic malignancies, the prevalence of lymph node metastases is similar in calcified and non-calcified lymph nodes.
Read the detailed description
The presence of calcifications, which is a relatively common feature in intrathoracic lymph nodes, typically contributes to confer them a heterogeneous aspect during endosonographic B-mode examination, but a possible association between calcifications and metastatic involvement has never been systematically evaluated. The most likely reason why this possible association has been overlooked up to now is that the presence of calcifications in intrathoracic lymph nodes has long been thought to be the consequence of the prior involvement from granulomatous diseases (i.e., tuberculosis or sarcoidosis), and as such has been considered a sign of benignity. However, the presence of lymph node calcifications at ultrasound examination is a known predictor of lymph node metastasis in patients with some specific tumours, such as the papillary thyroid carcinoma or the squamous cell carcinoma of head or neck. Furthermore, recent radiological-pathological studies have shown that metastatic foci from lung cancer are observed in up to 19% calcified mediastinal lymph nodes identified at CT in surgical candidates. Finally, a recently published EBUS study has reported, for the first time, a very strong association between a very specific pattern of mediastinal lymph node calcification, known as "starry sky sign", and metastasis from pulmonary, colonic and breast adenocarcinoma. Interestingly, the starry sky sign is characterized by the presence of few to countless dot-like calcifications which are too small to be seen at CT and can be identified only during EBUS B-mode examination.
To the best of our knowledge, no studies have been carried out to assess the correlation between the presence and the ultrasound pattern of lymph node calcifications and lymph node metastasis from lung cancer or other intrathoracic malignancies.
- Conditions
- Lymphadenopathy, Lung Cancer, Sarcoidosis, Tuberculosis
- Being tested
- Endosonography B-mode examination
- Medical subject headings
- Lymphadenopathy, Lung Neoplasms, Sarcoidosis, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endosonography B-mode examinationDevice
Endobronchial ultrasound (EBUS) or Endoscopic with bronchoscope (EUS-B) B-mode examination and sampling, when indicated, of lymphadenopathy
| Study group | Role | What they receive |
|---|---|---|
| Endosonography group | Patients with known or suspected lung cancer or intrathoracic malignancy with indication to endosonography for diagnosis or staging of intrathoracic lymph nodes according to currently accepted international guidelines Receives: Device: Endosonography B-mode examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of metastatic involvement in intrathoracic lymph nodes featuring calcifications of any type
The prevalence of malignancy in patients with calcified intrathoracic lymph nodes will be calculated on a per lymph node basis and will be compared with the prevalence of malignancy observed in non-calcified lymph nodes
Measured: 6 months
Secondary outcomes (3)
The prevalence of metastatic involvement from lung cancer linked to 5 predefined patterns of lymph node calcification at B-mode ultrasound examination carried out during endosonography
These are the 5 patterns of calcification: a) single macrocalcification; b) multiple macrocalcifications; c) single microcalcification or local cluster of microcalcifications involving a limited area (< 20%) of the lymph node; d) few (< 10) scattered microcalcifications not distributed in a local cluster; e) countless, punctate (< 1 mm) non shadowing foci distributed across the whole lymph node (starry sky sign).
Measured: 6 months
The interobserver agreement for the identification of 5 predefined patterns of lymph node calcification at endosonographic B-mode ultrasound examination
At the end of the study, two experienced endosonographers from different units/centers, blinded to the clinical, radiological (CT, PET) and pathological details, will be provided a video-clip of each calcified lymph node and will be asked to classify the pattern of calcification.
Measured: 1 month
The prevalence of actionable mutations in the overall cohort of calcified lymph nodes identified with endosonography
This prevalence will be calculated on a per patient basis and will be compared with the prevalence of actionable mutations in a group of consecutive patients with non-calcified lymph nodes submitted to endosonography in the same study period and with the same indications and inclusion/exclusion criteria
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start20 Mar 2021
- Primary completion30 Apr 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphadenopathyStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rocco Trisolini, MD, Principal investigator, Catholic University of the Sacred Hearth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743583
- Sponsor's protocol ID
- 3872
- Status last verified
- Apr 2022
- First submitted
- 3 Feb 2021
- Last updated
- 10 Jan 2023
- Results posted
- 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 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Intrathoracic Lymph Node Calcifications and Metastatic Involvement in Patients Undergoing Endosonography for Diagnosis and/or Mediastinal Staging of Intrathoracic Malignancy: a Cross-sectional Pilot Study
- ClinicalTrials.gov ID
- NCT04743583
- Acronym / sponsor ID
- 3872
- Conditions
- Lymphadenopathy, Lung Cancer, Sarcoidosis, Tuberculosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 20 Mar 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 8 Feb 2021 (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.
The presence of calcifications, which is a relatively common feature in intrathoracic lymph nodes, typically contributes to confer them a heterogeneous aspect during endosonographic B-mode examination, but their prevalence and a possible association between calcifications and metastatic involvement has never been systematically evaluated. We hypothesize that, in patients undergoing mediastinal diagnosis or staging of suspected/known lung cancer/intrathoracic malignancies, the prevalence of lymph node metastases is similar in calcified and non-calcified lymph nodes.
Detailed description
The presence of calcifications, which is a relatively common feature in intrathoracic lymph nodes, typically contributes to confer them a heterogeneous aspect during endosonographic B-mode examination, but a possible association between calcifications and metastatic involvement has never been systematically evaluated. The most likely reason why this possible association has been overlooked up to now is that the presence of calcifications in intrathoracic lymph nodes has long been thought to be the consequence of the prior involvement from granulomatous diseases (i.e., tuberculosis or sarcoidosis), and as such has been considered a sign of benignity. However, the presence of lymph node calcifications at ultrasound examination is a known predictor of lymph node metastasis in patients with some specific tumours, such as the papillary thyroid carcinoma or the squamous cell carcinoma of head or neck. Furthermore, recent radiological-pathological studies have shown that metastatic foci from lung cancer are observed in up to 19% calcified mediastinal lymph nodes identified at CT in surgical candidates. Finally, a recently published EBUS study has reported, for the first time, a very strong association between a very specific pattern of mediastinal lymph node calcification, known as "starry sky sign", and metastasis from pulmonary, colonic and breast adenocarcinoma. Interestingly, the starry sky sign is characterized by the presence of few to countless dot-like calcifications which are too small to be seen at CT and can be identified only during EBUS B-mode examination.
To the best of our knowledge, no studies have been carried out to assess the correlation between the presence and the ultrasound pattern of lymph node calcifications and lymph node metastasis from lung cancer or other intrathoracic malignancies.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endosonography group | – | Device: Endosonography B-mode examinationPatients with known or suspected lung cancer or intrathoracic malignancy with indication to endosonography for diagnosis or staging of intrathoracic lymph nodes according to currently accepted international guidelines |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with known or suspected lung cancer or other intrathoracic malignancy with indication to endosonography for diagnosis or staging of intrathoracic lymph nodes according to currently accepted international guidelines
Key inclusion criteria (3 listed)
- Age >18 years at the time of the procedure
- Known or suspected lung cancer or other intrathoracic malignancy based on imaging (CT and/or PET/CT)
- Endosonography (EBUS and/or EUS) indicated for intrathoracic lymph node assessment/sampling according to national and international guidelines: 1) enlarged (> 1 cm on its short axis at CT) and/or PET positive lymph node; and/or 2) conditions at risk for occult mediastinal metastases, such as: i) central primary tumor; ii) primary tumor > 3 cm; iii) PET negative primary tumor; iv) ipsilateral hilar metastasis (cN1 status).
Key exclusion criteria (4 listed)
- Inability or unwillingness to consent
- Compromised upper airway (i.e., concomitant head and neck cancer with upper airway obstruction; critical central airway obstruction from any cause)
- Contraindication for temporary interruption of the use of antiplatelet (excluded aspirin) or anticoagulant drugs
- American Society of Anesthesiologists grade 4
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 |
|---|---|---|
| Endosonography B-mode examinationEndobronchial ultrasound (EBUS) or Endoscopic with bronchoscope (EUS-B) B-mode examination and sampling, when indicated, of lymphadenopathy | Device | Endosonography group |
Primary outcome
prevalence of metastatic involvement in intrathoracic lymph nodes featuring calcifications of any type
Time frame: 6 months
The prevalence of malignancy in patients with calcified intrathoracic lymph nodes will be calculated on a per lymph node basis and will be compared with the prevalence of malignancy observed in non-calcified lymph nodes
3 secondary outcomes
The prevalence of metastatic involvement from lung cancer linked to 5 predefined patterns of lymph node calcification at B-mode ultrasound examination carried out during endosonography
Time frame: 6 months
The interobserver agreement for the identification of 5 predefined patterns of lymph node calcification at endosonographic B-mode ultrasound examination
Time frame: 1 month
The prevalence of actionable mutations in the overall cohort of calcified lymph nodes identified with endosonography
Time frame: 1 month
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 10 Jan 2023.
- 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.
Rocco Trisolini, MD principal investigator
Catholic University of the Sacred Hearth
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 Lymphadenopathy and Lung Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 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: finished, as of the sponsor's last update on 10 Jan 2023. 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?
prevalence of metastatic involvement in intrathoracic lymph nodes featuring calcifications of any type (time frame: 6 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 10 Jan 2023.