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

NCT ID: NCT05072561

Last Updated: 2021-12-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-17
• Study Completion Date: 2022-07-01

Brief 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

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

Group Type: EXPERIMENTAL

Sentinel lymph node scintigraphy

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Newly diagnosis of stage I-IIIa NSCLC (higher stage could be considered, pending a multidisciplinary evaluation and approval).
• Baseline 18FFDG-PET-CT and ceCT
• Treatment according to good clinical practice

Exclusion Criteria

• Unavailability of baseline images
• Diagnosis other than NSCLC at definitive pathology
• Surgery carried without complete resection or with no curative intent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istituto Clinico Humanitas

Rozzano, Milano, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Arturo Chiti, Professor

Role: CONTACT

Phone: +390282246621

Email: arturo.chiti@hunimed.eu

Lidija Antunovic, MD

Role: CONTACT

Phone: +390282247545

Email: lidija.antunovic@humanitas.it

Facility Contacts

Arturo Chiti, Professor

Role: primary

Lidija Antunovic, MD

Role: backup

Other Identifiers

1957

Identifier Type: -

Identifier Source: org_study_id