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

April 16, 2024 updated by: Radboud University Medical Center

Injection of 99mTc-nanocolloid and ICG to Identify, Retrieve and Qualify Tumor Draining Lymph Nodes in Early-stage Lung Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • SLN procedure
  • Elective lung surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of SLN procedure
Time Frame: 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.
During the study intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Successfulness of injection method (intra- or peritumoral)
Time Frame: During the first intervention
During the first intervention
Number of SLN found by SPECT/CT-imaging
Time Frame: On the day of the first intervention
On the day of the first intervention
Number of SLN found by ICG
Time Frame: On the day of the second intervention
On the day of the second intervention
Number of metastasis found by additional pathology
Time Frame: Up to two weeks after the second intervention
Up to two weeks after the second intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Johnson & Johnson
Philips Healthcare

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2022

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

May 31, 2022

First Submitted That Met QC Criteria

September 22, 2022

First Posted (Actual)

September 26, 2022

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 113036
  • NL81008.000.22 (Other Identifier: CCMO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

(Pseudonymized) metadata will be stored for reuse and/or verification.

IPD Sharing Time Frame

Data will be accessible for an unknown time after publication of the results.

IPD Sharing Access Criteria

Under reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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