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

Primary Purpose

Early-stage Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
99mTc-nanocolloid
ICG
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Early-stage Lung Cancer focused on measuring Sentinel Lymph Node procedure, 99mTc-nanocolloid, ICG, SPECT/CT-imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • RadboudumcRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Successfulness of injection method (intra- or peritumoral)
Number of SLN found by SPECT/CT-imaging
Number of SLN found by ICG
Number of metastasis found by additional pathology

Full Information

First Posted
May 31, 2022
Last Updated
December 9, 2022
Sponsor
Radboud University Medical Center
Collaborators
Philips Healthcare, Johnson & Johnson
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1. Study Identification

Unique Protocol Identification Number
NCT05555199
Brief Title
Injection of 99mTc-nanocolloid and ICG to Identify, Retrieve and Qualify TDLN in Early-stage NSCLC
Acronym
INITIATE
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2022 (Actual)
Primary Completion Date
August 3, 2024 (Anticipated)
Study Completion Date
October 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Philips Healthcare, Johnson & Johnson

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early-stage Lung Cancer
Keywords
Sentinel Lymph Node procedure, 99mTc-nanocolloid, ICG, SPECT/CT-imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a prospective, single-center, non-randomized, interventional study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
One interventional arm that will undergo all interventional procedures (when applicable).
Intervention Type
Radiation
Intervention Name(s)
99mTc-nanocolloid
Other Intervention Name(s)
Elective navigation bronchoscopy, SLN procedure
Intervention Description
Injection of 99mTc-nanocolloid when lung cancer is diagnosed during a navigation bronchoscopy, followed by one or two SPECT/CT-scans.
Intervention Type
Drug
Intervention Name(s)
ICG
Other Intervention Name(s)
Elective lung surgery, SLN procedure
Intervention Description
If patient undergoes surgery to treat the lung cancer, ICG will be injected and retrieved fluorescent lymph nodes will undergo additional pathological assessment.
Primary Outcome Measure Information:
Title
Feasibility of SLN procedure
Description
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.
Time Frame
During the study intervention
Secondary Outcome Measure Information:
Title
Successfulness of injection method (intra- or peritumoral)
Time Frame
During the first intervention
Title
Number of SLN found by SPECT/CT-imaging
Time Frame
On the day of the first intervention
Title
Number of SLN found by ICG
Time Frame
On the day of the second intervention
Title
Number of metastasis found by additional pathology
Time Frame
Up to two weeks after the second intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erik H van der Heijden, Dr.
Phone
+31243697347
Email
erik.vanderheijden@radboudumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Desi KM ter Woerds, MSc.
Email
desi.terwoerds@radboudumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik HF van der Heijden, Dr.
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Desi KM ter Woerds, MSc.
Organizational Affiliation
Radboud University Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Roel LJ Verhoeven, Dr.
Organizational Affiliation
Radboud University Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Erik HJ Aartnzen, Dr.
Organizational Affiliation
Radboud University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Radboudumc
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Desi KM ter Woerds, MSc.
Email
desi.terwoerds@radboudumc.nl

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
32557077
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.
Results Reference
background
PubMed Identifier
23352034
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.
Results Reference
background
PubMed Identifier
22726707
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.
Results Reference
background
PubMed Identifier
24480258
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.
Results Reference
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Injection of 99mTc-nanocolloid and ICG to Identify, Retrieve and Qualify TDLN in Early-stage NSCLC

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