The Safety and Feasibility of Costal Bone Marrow Aspiration During Thoracic Surgery

Non Small Cell Lung Cancer Clinical Trial

Official title:

Phase I Clinical Trial Evaluating the Safety and Feasibility of Bone Marrow Aspiration From Ribs During Thoracic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05251805
• Other study ID #: UZB-DVH-2022-01
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2023
• Source: Universitair Ziekenhuis Brussel
• Contact: Domien Vanhonacker, MD
• Phone: 024749293
• Email: domien.vanhonacker[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot trial is designed to evaluate the feasibility and safety of obtaining bone marrow from costal aspiration during surgery. The investigators hypothese that sufficient bone marrow-derived HSPC's (which represent only 0,1% of the total bone marrow fraction) can be derived by rib bone marrow aspiration for ex vivo single-cell evaluation, optimization of a 3D BMN platform and preclinical ex/in vivo assessment in patient-derived organoids and murine xenograft models.

Description:

This pilot trial is designed to evaluate the feasibility and safety of obtaining bone marrow from costal aspiration during surgery. Previous trials demonstrated the feasibility of micro-metastasis detection in rib marrow aspirate. This procedure appears safe since no adverse events were documented during previous trials. The investigators hypothesize this technique can be used to obtain sufficient bone marrow-derived HSPC's (which represent only 0,1% of the total bone marrow fraction) for ex vivo single-cell evaluation, optimization of a 3D BMN platform and preclinical ex/in vivo assessment in patient-derived organoids and murine xenograft models. The use of rib marrow eliminates the need for extra incisions because the cuts made for trocar placement or the thoracotomy can be re-used. Therefore, the investigators hypothesize that the patients undergoing costal bone marrow aspiration during surgery will not experience extra discomfort. Every patient undergoing thoracic surgery is treated according to ERAS protocols with a major emphasis on pain control. If the feasibility and safety of bone marrow aspiration are confirmed by this pilot trial, the investigators plan to conduct a large-scale study in which they will collect and bank blood, bone marrow and tumor per NSCLC patient. With this unique autologous biological material collection, the investigators aspire to conduct innovative research into the current resistance mechanisms of NSCLC to immunotherapy;

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient undergoing thoracic surgery for a confirmed or suspected lung cancer

Exclusion Criteria:

• Uncertainty of pre-operative diagnosis, exception is per-op frozen section analysis confirming malignity
• ASA = 3
• Bleeding disorders

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Intervention

Procedure:
• Blood, bone marrow and lung tumor tissue collection
Blood sampling: 12ml of blood will be collected during the routine pre-operative blood collection Bone marrow aspiration during thoracic surgery: following the surgical intervention, bone marrow aspiration will be performed through the incisions made for the thoracic procedure. The ribs lying directly above and below the trocar incision will be exposed. A bone marrow needle will be advanced into the periost until the needle tip reaches the bone marrow. After removing the stylet a 2ml syringe will be attached to the aspiration needle and 0.5ml to 2ml of bone marrow will be aspirated before removing the needle. This procedure will be repeated twice for every trocar site, for a maximum of 3 trocar sites, or until 5ml of bone marrow aspirate is obtained. Lung tumor collection: all surgical samples will be analyzed by our anatomopathological department. Viable and fresh material, not used for the diagnostic purposes, will be sent to the LMCT.

Locations

Country	Name	City	State
Belgium	UZ Brussel	Jette	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurrence of adverse events following costal bone marrow aspiration classified by Calvien Dindo	All adverse events will be classified by the Clavien Dindo classification. The study will be closed prematurely if 2 patients experience a grade 3 adverse event directly related to the bone marrow aspiration	7 days following surgery
Secondary	Measurement of the amount of HPSC's that can be obtained from costal bone marrow	a minimum of 2x106 Lin- CD34+ HPSC are required to allow single cell sequencing, 3D bone marrow cultivation and transplantation in immunodeficient mice.	7 days following aspiration from the bone marrow