Clinical trial NCT05555199: Injection of 99mTc-nanocolloid and ICG to Identify, Retrieve and Qualify TDLN in Early-stage NSCLC
Official title: Injection of 99mTc-nanocolloid and ICG to Identify, Retrieve and Qualify Tumor Draining Lymph Nodes in Early-stage Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early-stage Lung Cancer
Keywords: Sentinel Lymph Node procedure
99mTc-nanocolloid
ICG
SPECT/CT-imaging
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
name: Johnson & Johnson
First posted: 2022-09-26
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, single-center, non-randomized, interventional study.
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of SLN procedure
timeFrame: During the study intervention
Secondary outcomes:
measure: Successfulness of injection method (intra- or peritumoral)
timeFrame: During the first intervention
measure: Number of SLN found by SPECT/CT-imaging
timeFrame: On the day of the first intervention
measure: Number of SLN found by ICG
timeFrame: On the day of the second intervention
measure: Number of metastasis found by additional pathology
timeFrame: Up to two weeks after the second intervention
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Erik HF van der Heijden, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Desi KM ter Woerds, MSc.
role: STUDY_DIRECTOR
affiliation: Radboud University Medical Center
name: Roel LJ Verhoeven, Dr.
role: STUDY_DIRECTOR
affiliation: Radboud University Medical Center
name: Erik HJ Aartnzen, Dr.
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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.
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.