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

Early-stage Lung Cancer Clinical Trial

— INITIATE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05555199
• Other study ID #: 113036
• Secondary ID: NL81008.000.22
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: Radboud University Medical Center
• Contact: Erik H van der Heijden, Dr.
• Phone: +31243697347
• Email: erik.vanderheijden[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Early-stage Lung Cancer
• Lung Neoplasms

Intervention

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

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.

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (3)

Lead Sponsor	Collaborator
Radboud University Medical Center	Johnson & Johnson, Philips Healthcare

Country where clinical trial is conducted

Netherlands, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Successfulness of injection method (intra- or peritumoral)		During the first intervention
Secondary	Number of SLN found by SPECT/CT-imaging		On the day of the first intervention
Secondary	Number of SLN found by ICG		On the day of the second intervention
Secondary	Number of metastasis found by additional pathology		Up to two weeks after the second intervention