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Trial Title:
Injection of 99mTc-nanocolloid and ICG to Identify, Retrieve and Qualify TDLN in Early-stage NSCLC
NCT ID:
NCT05555199
Condition:
Early-stage Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Sentinel Lymph Node procedure
99mTc-nanocolloid
ICG
SPECT/CT-imaging
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
This is a prospective, single-center, non-randomized, interventional study.
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
99mTc-nanocolloid
Description:
Injection of 99mTc-nanocolloid when lung cancer is diagnosed during a navigation
bronchoscopy, followed by one or two SPECT/CT-scans.
Arm group label:
Intervention
Other name:
Elective navigation bronchoscopy
Other name:
SLN procedure
Intervention type:
Drug
Intervention name:
ICG
Description:
If patient undergoes surgery to treat the lung cancer, ICG will be injected and retrieved
fluorescent lymph nodes will undergo additional pathological assessment.
Arm group label:
Intervention
Other name:
Elective lung surgery
Other name:
SLN procedure
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Radboudumc
Address:
City:
Nijmegen
Zip:
6525 GA
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Desi KM ter Woerds, MSc.
Email:
desi.terwoerds@radboudumc.nl
Start date:
October 3, 2022
Completion date:
September 30, 2024
Lead sponsor:
Agency:
Radboud University Medical Center
Agency class:
Other
Collaborator:
Agency:
Philips Healthcare
Agency class:
Industry
Collaborator:
Agency:
Johnson & Johnson
Agency class:
Industry
Source:
Radboud University Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05555199
