Real-Time Image Guided Lymphatic Mapping and Nodal Targeting in Lung Cancer

NCT00264602 | Active Not Recruiting Phase 1

• 1 other identifier: 05-219
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 4

Brief Summary

The primary purpose of this study is to determine if we can 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.

Conditions

Lung Cancer

Keywords

Lymphatic mapping; nodal targeting; indocyanine green; near infrared imaging

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and efficacy of near-infrared technology to guide therapeutic sentinel lymph node dissection in patients with lung cancer.

  3 years

Study Arms (1)

Near Infrared Imaging

EXPERIMENTAL

The intervention to be administered is indocyanine green dye.

Drug: Near Infrared Imaging

Interventions

Near Infrared Imaging DRUG

Dye injected into or around tumor at the time of surgery

Also known as: Indocyanine Green, Sentinel Lymph Node

Near Infrared Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suspected or histologically documented new non-small cell carcinoma that have agreed to undergo a thoracotomy for segmentectomy, lobectomy, bilobectomy or pneumonectomy as recommended by their thoracic surgeon for treatment
• Surgically resectable lung cancer
• N2 lymph nodes negative on PET scan or mediastinoscopy
• Age \> or equal to 18 years of age
• Men, women of non-child bearing age or women with a negative pregnancy test

You may not qualify if:

• Patient does not want to undergo subsequent surgical resection
• Medical condition such as uncontrolled infection or cardiac disease that, i the opinion of the treating surgeon, makes resection unreasonably hazardous for the patient.
• T4 or N2 disease
• Pre-operative spirometry that suggests they cannot undergo resection of their primary tumor by segmentectomy, lobectomy, bilobectomy, or pneumonectomy
• Iodide or seafood allergy
• Pregnant or lactating women

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (4)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Indocyanine Green; Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Study Officials

• Yolonda L. Colson, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: There is no masking in this study. All study subjects will receive the same intervention.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 12, 2005
• First Posted: December 13, 2005
• Study Start: February 18, 2009
• Primary Completion: September 1, 2017
• Study Completion (Estimated): December 1, 2029
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)