LymphadenopathyNCT02948907
"Elastography" and "Tissue Harmonic Imaging" for Characterisation of Hilar and Mediastinal Lymph Nodes
A study testing Procedure/Bronchoscopy in people with Lymphadenopathy, run by Heidelberg University at 1 site in Germany.
Trial summary
Several benign and malignant diseases are associated with hilar and mediastinal lymphadenopathy. Endobronchial elastography that is an imaging procedure used for the visualization of tissue elasticity and "Tissue Harmonic Imaging (THI)" might be useful for the differentiation of benign and malignant lymph nodes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphadenopathy
- What is being tested?
- Procedure/Bronchoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2015to Mar 2020
- Phase
- Interventional
- 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
Who may be able to join
- Indication for EBUS-TBNA
- Patient has provided written informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endobronchial Ultrasound "Elastography" and "Tissue Harmonic Imaging" for Characterisation of Hilar and Mediastinal Lymph Nodes
Several benign and malignant diseases are associated with hilar and mediastinal lymphadenopathy. Endobronchial elastography that is an imaging procedure used for the visualization of tissue elasticity and "Tissue Harmonic Imaging (THI)" might be useful for the differentiation of benign and malignant lymph nodes.
Read the detailed description
Patient enrolment and data acquisition is to be carried out on a prospective basis. Patients with hilar and/or mediastinal lymphadenopathy and indication for EBUS-TBNA are enroled. It is planned to evaluate 100 lymph nodes by elastography and THI. All patients will undergo diagnostic bronchoscopy at one study centre in Heidelberg.
- Conditions
- Lymphadenopathy
- Being tested
- Procedure/Bronchoscopy
- Medical subject headings
- Lymphadenopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure/BronchoscopyOther
Patients with enlarged hilar and/or mediastinal lymph nodes and indication for EBUS-TBNA undergo diagnostic bronchoscopy. For characterisation of the enlarged lymph nodes endobronchial ultrasound with elastography and "Tissue Harmonic Imaging (THI)" are used. Afterwards, EBUS-TBNA is performed. The results of elastography and THI are correlated with the cytological result obtained by EBUS-TBNA.
| Study group | Role | What they receive |
|---|---|---|
| Procedure/Bronchoscopy | Other | Patients with enlarged hilar and/or mediastinal lymph nodes and indication for EBUS-TBNA undergo diagnostic bronchoscopy. For characterisation of the enlarged lymph nodes, endobronchial ultrasound with elastography and "Tissue Harmonic Imaging (THI)" are used. Afterwards, EBUS-TBNA is performed. The results of elastography and THI are correlated with the cytological results obtained by EBUS-TBNA. Receives: Other: Procedure/Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of elastography and "Tissue Harmonic Imaging"
Correlation of imaging results and cytological results after bronchoscopic procedure
Measured: Once after bronchoscopic procedure
Secondary outcomes (1)
Safety of endobronchial use of elastography and "Tissue Harmonic Imaging" assessed by Incidence of adverse events
Incidence of adverse events (e.g. bleeding, pneumothorax)
Measured: during diagnostic bronchoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study startSep 2015
- Primary completion1 Dec 2019
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphadenopathyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felix JF Herth, Heidelberg University
- Investigators
- Felix Herth, MD, Principal investigator, Thoraxklinik at University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948907
- Sponsor's protocol ID
- Protocol F1.0 - 22/05/2013
- Status last verified
- Aug 2022
- First submitted
- 19 Sep 2016
- Last updated
- 2 Sep 2022
- Results posted
- No
Publications
Gompelmann D, Kontogianni K, Sarmand N, Kaukel P, Krisam J, Eberhardt R, Herth FJF. Endobronchial Ultrasound Elastography for Differentiating Benign and Malignant Lymph Nodes. Respiration. 2020;99(9):779-783. doi: 10.1159/000509297. Epub 2020 Oct 7.
PubMed 33027791
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endobronchial Ultrasound "Elastography" and "Tissue Harmonic Imaging" for Characterisation of Hilar and Mediastinal Lymph Nodes
- ClinicalTrials.gov ID
- NCT02948907
- Acronym / sponsor ID
- Protocol F1.0 - 22/05/2013
- Conditions
- Lymphadenopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 31 Oct 2016 (estimated)
- 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.
Several benign and malignant diseases are associated with hilar and mediastinal lymphadenopathy. Endobronchial elastography that is an imaging procedure used for the visualization of tissue elasticity and "Tissue Harmonic Imaging (THI)" might be useful for the differentiation of benign and malignant lymph nodes.
Detailed description
Patient enrolment and data acquisition is to be carried out on a prospective basis. Patients with hilar and/or mediastinal lymphadenopathy and indication for EBUS-TBNA are enroled. It is planned to evaluate 100 lymph nodes by elastography and THI. All patients will undergo diagnostic bronchoscopy at one study centre in Heidelberg.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Procedure/Bronchoscopy | Other | Other: Procedure/BronchoscopyPatients with enlarged hilar and/or mediastinal lymph nodes and indication for EBUS-TBNA undergo diagnostic bronchoscopy. For characterisation of the enlarged lymph nodes, endobronchial ultrasound with elastography and "Tissue Harmonic Imaging (THI)" are used. Afterwards, EBUS-TBNA is performed. The results of elastography and THI are correlated with the cytological results obtained by EBUS-TBNA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Indication for EBUS-TBNA
- Patient has provided written informed consent
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Procedure/BronchoscopyPatients with enlarged hilar and/or mediastinal lymph nodes and indication for EBUS-TBNA undergo diagnostic bronchoscopy. For characterisation of the enlarged lymph nodes endobronchial ultrasound with elastography and "Tissue Harmonic Imaging (THI)" are used. Afterwards, EBUS-TBNA is performed. The results of elastography and THI are correlated with the cytological result obtained by EBUS-TBNA. | Other | Procedure/Bronchoscopy |
Primary outcome
Diagnostic accuracy of elastography and "Tissue Harmonic Imaging"
Time frame: Once after bronchoscopic procedure
Correlation of imaging results and cytological results after bronchoscopic procedure
1 secondary outcome
Safety of endobronchial use of elastography and "Tissue Harmonic Imaging" assessed by Incidence of adverse events
Time frame: during diagnostic bronchoscopy procedure
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 2 Sep 2022.
- Results publication: PubMed 33027791Gompelmann D, Kontogianni K, Sarmand N, Kaukel P, Krisam J, Eberhardt R, Herth FJF. Endobronchial Ultrasound Elastography for Differentiating Benign and Malignant Lymph Nodes. Respiration. 2020;99(9):779-783. doi: 10.1159/000509297. Epub 2020 Oct 7.
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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.
Felix Herth, MD principal investigator
Thoraxklinik at University of Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure/Bronchoscopy in people with Lymphadenopathy, run by Heidelberg University at 1 site in Germany.
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 0 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 2 Sep 2022. 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 Germany. 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?
Diagnostic accuracy of elastography and "Tissue Harmonic Imaging" (time frame: Once after bronchoscopic procedure). 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 NCT02948907, which also lists 1 linked publication.
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 2 Sep 2022.