Clinical trial · Observational
Prevalence and Malignant Involvement of Calcified Intrathoracic Lymph Nodes in Patients Undergoing Endosonography
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lymphadenopathy | — | UNRESOLVED | — |
| Sarcoidosis | — | UNRESOLVED | — |
| Tuberculosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endosonography B-mode examination | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Endosonography group
- description
- 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
- interventionNames
- Device: Endosonography B-mode examination
Primary outcomes (1)
- measure
- prevalence of metastatic involvement in intrathoracic lymph nodes featuring calcifications of any type
- timeFrame
- 6 months
- description
- 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
Secondary outcomes (3)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * 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). Exclusion Criteria: * 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
References
Publications (0)
Data not yet available