Lung CancerNCT06252129
Maximizing Lymph Node Dissection on Fresh and Fixed Lung Cancer Resection Specimens
A study testing Subjects undergoing a lung specimen lymph node dissection in people with Lung Cancer and Lymph Node Metastasis, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Lung cancer patients undergoing upfront surgery, highly benefit from a systematic lymph node dissection in the mediastinum and in the surgical specimens. The latter is performed by the pathologist. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Lymph Node Metastasis, Pathologic Processes
- What is being tested?
- Subjects undergoing a lung specimen lymph node dissection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with a lung nodule or mass who are eligible to undergo a lobectomy.
- Subject without any metastasis present.
- Subjects who have peripheral lung nodule location
- Subjects must be 18 years of age or older.
Who cannot join
- Subjects who received preoperative chemotherapy or radiotherapy.
- Subjects who have a lung nodule located in a central location. Central tumors are defined by those infiltrating the lobar airway.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Womens Hospital
Boston, Massachusetts, 02115
Paula Ugalde Figueroa THORACIC SURGEON, MD, 617-794-6491, pugaldefigueroa@bwh.harvard.edu
About this study
Lung cancer patients undergoing upfront surgery, highly benefit from a systematic lymph node dissection in the mediastinum and in the surgical specimens. The latter is performed by the pathologist. Developing a standardized technique to dissect the lobectomy specimen has the potential of maximizing the retrieval of all N1 stations lymph nodes. The investigators believe that the adoption of such technique will improve lung cancer staging and identify a higher number of patients that qualify for adjuvant therapies.
Read the detailed description
Anatomic lung resection with systematic mediastinal lymph node dissection is the standard of care for patients with clinical stage I or II non-small cell lung cancer (NSCLC). While the best type of resection may sometimes be debated, it is clear that mediastinal, hilar, and lobar lymph nodes (LNs) should be routinely retrieved to achieve a complete lung cancer resection. According to major international guidelines, at least 3 hilar/intrapulmonary stations and 3 mediastinal stations should be assessed during resection. Although there is still a debate over whether the ideal number of LN stations sampled or the total number of LNs removed per station provides a better analysis, radical systematic LN dissection seems to offer the best oncological outcomes. In fact, in patients with tumors ≤4 cm in diameter completely resected, the quality of the mediastinal lymph node dissection and the thoroughness of the examination of the surgical specimen will select candidates for adjuvant treatment and define oncologic prognosis. The consequences of an incorrect lymph node classification can be substantial: while patients with N0 NSCLC have approximately 75% 5-year overall survival (OS), patients with NSCLC classified as N1 have a 5-year OS of 49%, and patients with NSCLC classified as N2 a 5-year OS of 36%. Therefore, the burden of determining the correct prognosis lies on the surgeon to perform a rigorous and thorough oncological resection, and on the pathologist to fully assess enough intrapulmonary LNs. Inaccuracy by either specialist leads to pathologic understage and suboptimal clinical management, which will lead to poor patient outcomes.
Developing a standardized technique to dissect the lobectomy specimen has the potential of maximizing the retrieval of all N1 stations lymph nodes. The investigators believe that the adoption of such technique will improve lung cancer staging and identify a higher number of patients that qualify for adjuvant therapies.
- Conditions
- Lung Cancer, Lymph Node Metastasis, Pathologic Processes
- Being tested
- Subjects undergoing a lung specimen lymph node dissection, Control group
- Keywords
- NSCLC, Lymph node dissection, Lung cancer staging
- Medical subject headings
- Lung Neoplasms, Lymphatic Metastasis, Pathologic Processes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subjects undergoing a lung specimen lymph node dissectionOther
A lobectomy specimen's resection will undergo systematic lymph node dissection either by the patient's treating thoracic surgeon and/or by a member of the pathology team.
The protocol for a standardized lymph node dissection consists of a series of blunt peribronchial dissections starting from the hilum to the periphery, with particular attention to points of airway bifurcation where intrapulmonary lymph nodes aggregate. By emphasizing the intrapulmonary lymph node map and a standardized dissection, the team will remove more lymph nodes from the lobectomy specimen, resulting in an accurate N staging.
Control groupOther
Control group
| Study group | Role | What they receive |
|---|---|---|
| 1. Interventional group | Experimental | subjects who are being consented to this study and undergoing lymph node dissection as outlined in this protocol Receives: Other: Subjects undergoing a lung specimen lymph node dissection |
| Concurrent non-interventional group | No intervention | Not described |
| Retrospective cohort from 2021-2020 | Other | Not described Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of lymph nodes sampled
To compare the number of stations and lymph nodes sampled when adopting a standardized technique compared to the conventional (prior) technique.
Measured: 2 weeks
Nodal upstage rate
Determine the number of cases upstaged to N1 with the intrapulmonary lymph node dissection compared to the conventional technique.
Measured: 2 weeks
Secondary outcomes (1)
3y RFS
Three years recurrence-free survival rate of patients undergoing standardize dissection versus conventional technique.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start26 Jul 2024
- Primary completionJan 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paula Antonia Ugalde Figueroa, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252129
- Sponsor's protocol ID
- DFCI IRB protocol #23-576
- Status last verified
- Mar 2026
- First submitted
- 21 Dec 2023
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximizing Lymph Node Dissection on Fresh and Fixed Lung Cancer Resection Specimens
- ClinicalTrials.gov ID
- NCT06252129
- Acronym / sponsor ID
- DFCI IRB protocol #23-576
- Conditions
- Lung Cancer, Lymph Node Metastasis, Pathologic Processes
- Keywords
- NSCLC, Lymph node dissection, Lung cancer staging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Feb 2024 (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.
Lung cancer patients undergoing upfront surgery, highly benefit from a systematic lymph node dissection in the mediastinum and in the surgical specimens. The latter is performed by the pathologist. Developing a standardized technique to dissect the lobectomy specimen has the potential of maximizing the retrieval of all N1 stations lymph nodes. The investigators believe that the adoption of such technique will improve lung cancer staging and identify a higher number of patients that qualify for adjuvant therapies.
Detailed description
Anatomic lung resection with systematic mediastinal lymph node dissection is the standard of care for patients with clinical stage I or II non-small cell lung cancer (NSCLC). While the best type of resection may sometimes be debated, it is clear that mediastinal, hilar, and lobar lymph nodes (LNs) should be routinely retrieved to achieve a complete lung cancer resection. According to major international guidelines, at least 3 hilar/intrapulmonary stations and 3 mediastinal stations should be assessed during resection. Although there is still a debate over whether the ideal number of LN stations sampled or the total number of LNs removed per station provides a better analysis, radical systematic LN dissection seems to offer the best oncological outcomes. In fact, in patients with tumors ≤4 cm in diameter completely resected, the quality of the mediastinal lymph node dissection and the thoroughness of the examination of the surgical specimen will select candidates for adjuvant treatment and define oncologic prognosis. The consequences of an incorrect lymph node classification can be substantial: while patients with N0 NSCLC have approximately 75% 5-year overall survival (OS), patients with NSCLC classified as N1 have a 5-year OS of 49%, and patients with NSCLC classified as N2 a 5-year OS of 36%. Therefore, the burden of determining the correct prognosis lies on the surgeon to perform a rigorous and thorough oncological resection, and on the pathologist to fully assess enough intrapulmonary LNs. Inaccuracy by either specialist leads to pathologic understage and suboptimal clinical management, which will lead to poor patient outcomes.
Developing a standardized technique to dissect the lobectomy specimen has the potential of maximizing the retrieval of all N1 stations lymph nodes. The investigators believe that the adoption of such technique will improve lung cancer staging and identify a higher number of patients that qualify for adjuvant therapies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. Interventional group | Experimental | Other: Subjects undergoing a lung specimen lymph node dissectionsubjects who are being consented to this study and undergoing lymph node dissection as outlined in this protocol |
| Concurrent non-interventional group | No intervention | – |
| Retrospective cohort from 2021-2020 | Other | Other: Control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with a lung nodule or mass who are eligible to undergo a lobectomy.
- Subject without any metastasis present.
- Subjects who have peripheral lung nodule location
- Subjects must be 18 years of age or older.
Key exclusion criteria (2 listed)
- Subjects who received preoperative chemotherapy or radiotherapy.
- Subjects who have a lung nodule located in a central location. Central tumors are defined by those infiltrating the lobar airway.
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 |
|---|---|---|
| Subjects undergoing a lung specimen lymph node dissectionA lobectomy specimen's resection will undergo systematic lymph node dissection either by the patient's treating thoracic surgeon and/or by a member of the pathology team. The protocol for a standardized lymph node dissection consists of a series of blunt peribronchial dissections starting from the hilum to the periphery, with particular attention to points of airway bifurcation where intrapulmonary lymph nodes aggregate. By emphasizing the intrapulmonary lymph node map and a standardized dissection, the team will remove more lymph nodes from the lobectomy specimen, resulting in an accurate N staging. | Other | 1. Interventional group |
| Control groupControl group | Other | Retrospective cohort from 2021-2020 |
Primary outcome
Number of lymph nodes sampled
Time frame: 2 weeks
To compare the number of stations and lymph nodes sampled when adopting a standardized technique compared to the conventional (prior) technique.
Nodal upstage rate
Time frame: 2 weeks
Determine the number of cases upstaged to N1 with the intrapulmonary lymph node dissection compared to the conventional technique.
1 secondary outcome
3y RFS
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subjects undergoing a lung specimen lymph node dissection in people with Lung Cancer and Lymph Node Metastasis, run by Brigham and Women's Hospital at 1 site in United States.
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 4 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: looking for participants now, as of the sponsor's last update on 5 Mar 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paula Ugalde Figueroa, M.D. ((617) 732-7696, pugaldefigueroa@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of lymph nodes sampled (time frame: 2 weeks). The study lists 2 primary outcomes in all. 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 5 Mar 2026.