Health TrialsbyHealthPanel

Bronchial NIR Image-guided Resection

ConditionSentinel Lymph Node
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

This is a clinical trial to evaluate the use of peritumoral injection of near-infrared dye indocyanine green to identify lung lesions and sentinel lymph nodes. The primary purpose is to determine if the use of ICG injected via navigational bronchoscopy, CT-guided or transthoracic allows us to identify the first lymph node that drains from the tumor, and thus would be the most likely site for metastatic disease, and remove it for analysis to improve the ability to detect tumor in this node and to remove this additional site that potentially contains tumor cells. Using this intraoperative imaging technique, we aim to improve the identification of lung nodules for resection and the intraoperative identification of sentinel lymph nodes in the event that a lymphadenectomy is performed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients that have agreed to undergo video assisted thoracoscopic surgery or thoracotomy for surgical resection as recommended by their thoracic surgeon.

18 years of age or older

Documented, signed, dated informed consent obtained prior to any study specific procedures being performed

Disqualifiers

Pregnant women are excluded and women of childbearing potential without a negative pregnancy test prior to study procedures. All patients with Iodine allergies will be excluded.

Trial design

Design model

Single group

Treatments tested in this trial

  • ICG Intervention

    Drug

    Patients enrolled in the study will undergo injection of near infrared dye indocyanine green around the lung lesion or within the adjacent segmental bronchus at the time of surgery via navigational bronchoscopy, or if not amenable to navigational bronchoscopy injection, then injection will be carried out via a transthoracic approach through the incision or under CT-guidance.

  • Near Infrared Imaging

    Device

    A near-infrared camera device will be used to detect indocyanine green following injection.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: ICG InterventionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of treatment-emergent adverse events (safety and feasibility) of intraoperative NIR-image-guided localization of lung lesions using peritumoral ICG injection.

In this initial proof-of-concept pilot trial for patients undergoing surgical resection of a suspicious lung lesion, we will translate the new technology of NIR-imaging to the OR and assess safety and feasibility of ICG delivery, optimize the ability to "NIR tattoo" and visualize lung lesions for targeted resection vs NIR-highlighted segmental resections, assess histology of the surgical margin and determine lesional characteristics which predict successful NIR imaging. Safety and feasibility will be measured quantitatively by the number of participants with treatment-related adverse events, as assessed by CTCAE v4.0.

Time frame
5 years

Secondary outcomes

1

Investigate whether SLNs can be identified using NIR-guidance following peritumoral ICG injection.

Technical difficulty and clinical complications have resulted in \< 50% of surgeons performing complete removal of tumor draining lymph nodes at the time of surgery. Therefore, we will assess the feasibility of SLN identification following ICG injection for "targeted" lymph node sampling and focused analysis staging. This Outcome will be addressed only in cases where a lymphadenectomy is performed.

Time frame
5 years
2

Assess if NIR image-guided SLN excision enhances detection of metastatic disease and whether the presence of untreated occult metastatic disease/mutational analysis of primary tumors/secondary sites of disease including SLNs are predictors of outcome

Studies in stage I and II lung cancer have demonstrated "occult" nodal metastatic disease affects clinical outcomes, however, currently there is no accurate means to identify micrometastatic nodal disease in these patients prospectively. Therefore, we will analyze the SLN results to determine whether prospectively identified "occult" micrometastatic disease in the SLN is a "predictor" of disease recurrence. This Outcome is pertinent only to cases in which a lymphadenectomy was performed.

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Society of University Surgeons

Collaborator

Brigham and Women's Hospital

Collaborator

Source ClinicalTrials.gov
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