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INITIATE: Injection of 99mTc-nanocolloid and ICG to Identify, Retrieve and Qualify TDLN in Early-stage NSCLC

Sponsor
Radboud University Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05555199
Collaborator
Philips Healthcare (Industry), Johnson & Johnson (Industry)
60
Enrollment
1
Location
1
Arm
24.2
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The patient wil receive intra- or peritumoral injections of 99mTc-nanocolloid if malignancy is found during a navigation bronchoscopy. A SPECT/CT-scan will be made to image injections sites and sentinel lymph nodes (SLN). If surgery takes place to treat the lung cancer, ICG will be injected and fluorescent lymph nodes will be extensively assessed by a pathologist.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

When malignancy is found during navigation bronchoscopy, study participants will receive intra- or peritumoral injections of 99mTc-nanocolloid. Following, up to 2 SPECT/CT-scans will be made to assess drainage of the injected tracer to the lymph nodes.

If patients undergo resection of the lung lesion, ICG will be injected. The involved lung tissue will be removed, followed by routine complete lymph node dissection. The fluorescent lymph nodes will be more extensively evaluated by the pathologist.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
This is a prospective, single-center, non-randomized, interventional study.This is a prospective, single-center, non-randomized, interventional study.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Injection of 99mTc-nanocolloid and ICG to Identify, Retrieve and Qualify Tumor Draining Lymph Nodes in Early-stage Lung Cancer
Actual Study Start Date :
Oct 3, 2022
Anticipated Primary Completion Date :
Aug 3, 2024
Anticipated Study Completion Date :
Oct 10, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

One interventional arm that will undergo all interventional procedures (when applicable).

Radiation: 99mTc-nanocolloid
Injection of 99mTc-nanocolloid when lung cancer is diagnosed during a navigation bronchoscopy, followed by one or two SPECT/CT-scans.
Other Names:
  • Elective navigation bronchoscopy
  • SLN procedure

    • Drug: ICG
    If patient undergoes surgery to treat the lung cancer, ICG will be injected and retrieved fluorescent lymph nodes will undergo additional pathological assessment.
    Other Names:
  • Elective lung surgery
  • SLN procedure

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Feasibility of SLN procedure [During the study intervention]

      This is a qualitative outcome measurement that will be assessed by the involved physicians based on the ability to inject 99mTc-nanocolloid and ICG, and the ability to detect the tumor draining lymph nodes based on their drainage patterns.

    Secondary Outcome Measures

    1. Successfulness of injection method (intra- or peritumoral) [During the first intervention]

    2. Number of SLN found by SPECT/CT-imaging [On the day of the first intervention]

    3. Number of SLN found by ICG [On the day of the second intervention]

    4. Number of metastasis found by additional pathology [Up to two weeks after the second intervention]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • ASA physical status 1-3;

    • Lung lesion between 1 and 5 cm;

    • Imaging-based disease free lymph nodes (N0);

    • Patient is deemed a candidate for definitive lung tissue resection by a thoracic surgeon.

    Exclusion Criteria:

    • Pregnancy;

    • Inability to consent;

    • Known or suspected allergy to 99mTc-nanocolloid or ICG.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Radboudumc Nijmegen Gelderland Netherlands 6525 GA

    Sponsors and Collaborators

    • Radboud University Medical Center
    • Philips Healthcare
    • Johnson & Johnson

    Investigators

    • Principal Investigator: Erik HF van der Heijden, Dr., Radboud University Medical Center
    • Study Director: Desi KM ter Woerds, MSc., Radboud University Medical Center
    • Study Director: Roel LJ Verhoeven, Dr., Radboud University Medical Center
    • Study Director: Erik HJ Aartnzen, Dr., Radboud University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Radboud University Medical Center
    ClinicalTrials.gov Identifier:
    NCT05555199
    Other Study ID Numbers:
    • 113036
    • NL81008.000.22
    First Posted:
    Sep 26, 2022
    Last Update Posted:
    Dec 12, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Radboud University Medical Center
    Sentinel Lymph Node procedure
    99mTc-nanocolloid
    ICG
    SPECT/CT-imaging
    Additional relevant MeSH terms:
    Lung Neoplasms

    Study Results

    No Results Posted as of Dec 12, 2022