MedTrace Logo

Feasibility of Radioisotope-guided Excision of Mediastinal Lymph Nodes in Patients With Non-small Cells Lung Carcinoma

NCT05072561 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-12-08

No results posted yet for this study

Summary

Non-small cells lung carcinoma (NSCLC) represents one of the most common and lethal neoplasms. NSCLC is characterized by an early asymptomatic phase, which hinders the disease identification in its earliest stages. As a consequence, NSCLC is often diagnosed at a clinical stage when the potentially curative surgical approach is challenging. In general, NSCLC up to the TNM stage cT3N2M0 are considered operable; in particular, nodal localizations in the homolateral hilus (N1) and underneath the carina (N2) are considered surgically manageable. Identification of nodal disease on the pre-operative PET/CT does not guarantee that all disease-bearing lymph node will be retrieved in the course of the open operative procedure. Smaller nodes might be challenging to identify; moreover, the co-existence of macroscopic and microscopic disease might hinder the radicality of the surgical intervention. This process can be tracked using specific radioactive radiopharmaceuticals, such as radioisotope-labelled colloids, which can be injected in the immediate proximity of the primary and then travel toward the closest cluster of mediastinal lymph nodes. There, they are incorporated in the nodal structure and progress no farther. By employing a radioisotope probe during surgery, all of the first-line nodes (so-called sentinel lymph node, SLN), which receive the lymphatic flow from the tumor region directly, can be identified.

The hypothesis of the investigators is that, by performing a radioisotope SLN mapping intraoperatively, the surgeons will be able to detect the metastatization process more accurately than relying on pre-operative imaging alone.

The present study will be a prospective and monocentric trial. Clinical, histological, and imaging data collected from examinations performed according to the good clinical practice will be analyzed. The estimated duration of the study is 12 months. It will include the prospective inclusion of patients with a diagnosis of operable NSCLC, who will receive a surgical treatment with curative intent at the investigators' institution (ICH).

Conditions

Interventions

DIAGNOSTIC_TEST

Sentinel lymph node scintigraphy

During the surgery, right after the identification of the primary, 18-37 MBq of 99mTc-Nanocolloids in two ml will be injected at four peritumoral locations. After a brief waiting time (5-10'), the thoracic surgeon will perform the clinical intervention, including the lobectomy (the injection sites will be resected alongside the tumour) and lymphadenectomy, according to the best clinical practice. All the excised lymph nodes will be ex vivo counted using a gamma probe: those with a detectable activity (at least 10% of the "hottest" lymph node) will be considered as SLN. Thereafter, the mediastinum will be scanned using the gamma probe and a handheld gamma-camera (the latter will not be employed in case of robotic-assisted surgery); any further source of radioactivity will be investigated and, should further lymph nodes be identified, these will be also resected and classified in SLN or non-SLN, based on ex vivo activity.

Sponsors & Collaborators

  • Istituto Clinico Humanitas

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-17
Primary Completion
2022-05-01
Completion
2022-07-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05072561 on ClinicalTrials.gov