Prevalence and Malignant Involvement of Calcified Intrathoracic Lymph Nodes in Patients Undergoing Endosonography

NCT04743583 | Completed

• 1 other identifier: 3872
• Study Type: observational
• Target: 362
• Locations: 1 country
• Sites: 1

Brief 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 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

Lymphadenopathy; Lung Cancer; Sarcoidosis; Tuberculosis

Outcome Measures

Primary Outcomes (1)

• 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

  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

  6 months

• The interobserver agreement for the identification of 5 predefined patterns of lymph node calcification at endosonographic B-mode ultrasound examination

  1 month

• The prevalence of actionable mutations in the overall cohort of calcified lymph nodes identified with endosonography

  1 month

Study Arms (1)

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

Device: Endosonography B-mode examination

Interventions

Endosonography B-mode examination DEVICE

Endobronchial ultrasound (EBUS) or Endoscopic with bronchoscope (EUS-B) B-mode examination and sampling, when indicated, of lymphadenopathy

Endosonography group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Italy

Location

MeSH Terms

Conditions

Lymphadenopathy; Lung Neoplasms; Sarcoidosis; Tuberculosis

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Lymphoproliferative Disorders; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Rocco Trisolini, MD

  Catholic University of the Sacred Hearth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 8, 2021
• Study Start: March 20, 2021
• Primary Completion: April 30, 2022
• Study Completion: December 31, 2022
• Last Updated: January 10, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)