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

NCT05069766 | Completed

• 1 other identifier: H-21041919
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophagus Cancer, Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

BioXmark™

EXPERIMENTAL

Other: BioXmark™

Interventions

BioXmark™ OTHER

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.

BioXmark™

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Nanovi: collaborator

Study Sites (1)

Rigshopitalet, Department of Surgery and Transplantation

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus

Study Officials

• Michael P Achiam, MD, DMSCi

  Rigshospitalet, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scholar

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 6, 2021
• Study Start: September 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)