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

NCT05555199 | Completed FDA Device

• 2 other identifiers: 113036NL81008.000.22
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Early-stage Lung Cancer

Keywords

Sentinel Lymph Node procedure; 99mTc-nanocolloid; ICG; SPECT/CT-imaging

Outcome Measures

Primary Outcomes (1)

• Feasibility of SLN procedure

  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 Outcomes (4)

• Successfulness of injection method (intra- or peritumoral)

  During the first intervention

• Number of SLN found by SPECT/CT-imaging

  On the day of the first intervention

• Number of SLN found by ICG

  On the day of the second intervention

• Number of metastasis found by additional pathology

  Up to two weeks after the second intervention

Study Arms (1)

Intervention

EXPERIMENTAL

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

Radiation: 99mTc-nanocolloid; Drug: ICG

Interventions

99mTc-nanocolloid RADIATION

Injection of 99mTc-nanocolloid when lung cancer is diagnosed during a navigation bronchoscopy, followed by one or two SPECT/CT-scans.

Also known as: Elective navigation bronchoscopy, SLN procedure

Intervention

ICG DRUG

If patient undergoes surgery to treat the lung cancer, ICG will be injected and retrieved fluorescent lymph nodes will undergo additional pathological assessment.

Also known as: Elective lung surgery, SLN procedure

Intervention

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy;
• Inability to consent;
• Known or suspected allergy to 99mTc-nanocolloid or ICG.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Philips Healthcare: collaborator
• Johnson & Johnson: collaborator

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Related Publications (4)

• Sun WYL, Dang JT, Modasi A, Nasralla A, Switzer NJ, Birch D, Turner SR, Karmali S. Diagnostic accuracy of sentinel lymph node biopsy using indocyanine green in lung cancer: a systematic review and meta-analysis. Gen Thorac Cardiovasc Surg. 2020 Sep;68(9):905-913. doi: 10.1007/s11748-020-01400-8. Epub 2020 Jun 16.

  PMID: 32557077 BACKGROUND

• Taghizadeh Kermani A, Bagheri R, Tehranian S, Shojaee P, Sadeghi R, N Krag D. Accuracy of sentinel node biopsy in the staging of non-small cell lung carcinomas: systematic review and meta-analysis of the literature. Lung Cancer. 2013 Apr;80(1):5-14. doi: 10.1016/j.lungcan.2013.01.001. Epub 2013 Jan 23.

  PMID: 23352034 BACKGROUND

• Gilmore DM, Khullar OV, Colson YL. Developing intrathoracic sentinel lymph node mapping with near-infrared fluorescent imaging in non-small cell lung cancer. J Thorac Cardiovasc Surg. 2012 Sep;144(3):S80-4. doi: 10.1016/j.jtcvs.2012.05.072. Epub 2012 Jun 20.

  PMID: 22726707 BACKGROUND

• Rena O, Boldorini R, Papalia E, Turello D, Massera F, Davoli F, Roncon A, Baietto G, Casadio C. Metastasis to subsegmental and segmental lymph nodes in patients resected for non-small cell lung cancer: prognostic impact. Ann Thorac Surg. 2014 Mar;97(3):987-92. doi: 10.1016/j.athoracsur.2013.11.051. Epub 2014 Jan 28.

  PMID: 24480258 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Erik HF van der Heijden, Dr.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, single-center, non-randomized, interventional study.

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: September 26, 2022
• Study Start: October 3, 2022
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: February 20, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be accessible for an unknown time after publication of the results.
• Access Criteria: Under reasonable request.

Locations

NL (1)