Preoperative Marking of the Oral Resection Margin in Esophageal Cancer With a Surgical Fiducial Marker - First Experiences

This study aims to evaluate if BioXmark™, a surgical marker, may efficiently and safely be used to preoperatively mark the proximal and distal resection line 5 cm proximal and distal to the tumor margin of gastroesophageal-junction adenocarcinoma (GEJ AC).

Furthermore, to determine if placing the resection margin according to the resection margin defined by BioXmark™ is superior to the current standard of a proximal resection line estimation by the individual surgeon based on the intraoperative findings.

Study Overview

• Status: Completed
• Conditions: Esophagus Cancer, Adenocarcinoma
• Intervention / Treatment: Other: BioXmark™

Detailed Description

In Denmark, the national guidelines for GEJ AC surgery are an R0 resection with a minimum 5 cm proximal and distal resection margin, measured in vivo. During the operation, the primary surgeon sets the resection margin according to the guidelines, with 5 cm on either side.

The Danish national guidelines are clear, but the literature behind them is not, and the recommendations for resection margins vary worldwide. With the lack of a strong literature-backed guideline and a surgical approach that is heavily dependent on the individual surgeon's estimate, the risk of a microscopic positive resection margin (R1 resection) increases. Both problems, namely resectability at the definitive surgery and the incidence of microscopic positive resection margins after resection, may be improved by preoperatively marking the tumor margins in vivo. This could be achieved with an endoscopically placed surgical marker.

One such surgical marker is BioXmark™, a liquid injectable and adherent fiducial marker that has shown promising results for image-guided adaptive radiotherapy in lung, bladder, and esophageal cancer. BioXmark™ is implanted during endoscopy and has appropriate visibility with good positional stability on CT, CBCT, and MRI. Furthermore, no adverse reactions or events have been reported yet.

The study will be performed as a feasibility study of BioXmark™ at the Department of Surgery & Transplantation, Centre of Cancer and Organ Diseases. The investigators plan to include 10 patients who are scheduled to undergo curatively intended surgery for GEJ AC. The patients will be drawn from the existing operating program.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshopitalet, Department of Surgery and Transplantation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients referred with gastroesophageal adenocarcinoma to the Department of Surgery & Transplantation, Centre of Cancer and Organ Diseases, Rigshospitalet, and who are candidates for curatively intended surgery.

Exclusion Criteria:

• Patients under the age of 18.
• Patients diagnosed with disseminated disease during surgery.
• Patients with impaired cognitive ability, making obtainment of informed consent impossible

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BioXmark™	Other: BioXmark™; During a scheduled outpatient gastroscopy, the tumor margins will be endoscopically marked by BioXmark™. BioXmark™ will be implanted at the most proximal margin of the tumor and 5 cm proximally of the tumor border.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Registration of visibility of BioXmark™	BioXmark™ feasibility in terms of visibility with ultrasound during surgery CT-scans after neoadjuvant and visibility and positional stability during CT-scanning following neoadjuvant chemotherapy preoperatively.	From day 0 to the day of operation
Registration of treatment related side effects assessed by CTCAE V 5.0	This is part of a safety evaluation and will be registered by CTCAE into Adverse Events (AE) and Serious Adverse Events (SAE)	Day 0 to 2 weeks after implantation

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Nanovi
• Investigators: Study Director: Michael P Achiam, MD, DMSCi, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: September 15, 2021
• First Submitted That Met QC Criteria: September 24, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: H-21041919

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No