Calcium Electroporation in Patients With Cell Changes in the Esophagus

Calcium Electroporation in Patients With Barrett's Esophagus High-grade Dysplasia

The aim of this first-in-man study is to evaluate the safety of calcium electroporation used in patients with Barrett's esophagus high-grade dysplasia through an endoscopic system.

Study Overview

• Status: Unknown
• Conditions: Barretts Esophagus With High Grade Dysplasia
• Intervention / Treatment: Procedure: Calcium electroporation

Detailed Description

After being informed about the study and potential risks, all patients give written informed consent. Thereafter, patient will get calcium electroporation with biopsies and digital photographs on day 0. We expect to discharge all patients same evening. Between day 3-7 an examination is followed by gastroscopy with biopsies and digital photographs. On day 14 the patients are followed in our outpatient clinic. 6 weeks after treatment the patients will undergo endoscopic mucosa resection (EMR) or endoscopic submucosa dissection (ESD) surgery and thereby the standard care of treatment for Barrett's esophagus high-grade dysplasia.

• Study Type: Interventional
• Enrollment (Anticipated): 6
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Michael Achiam, Md., Ph.D.; Phone Number: +45 35 45 04 41; Email: Michael.Patrick.Achiam.01@regionh.dk
• Study Contact Backup: Name: Laser Bazancir, Med. student; Phone Number: +45 60 63 20 48; Email: laser.arif.bazancir@regionh.dk

Study Locations

• Denmark
  • Region Hovedstaden
    • Copenhagen, Region Hovedstaden, Denmark, 2100
      • Recruiting
      • Rigshospitalet
      • Contact: Michael Achiam, Md., Ph.D.; Phone Number: +45 35 45 04 41; Email: Michael.Patrick.Achiam.01@regionh.dk

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Male or female ≥18 years old.
2. Histological verified Barrett's esophagus high-grade dysplasia (BE HGD)
3. Expected survival > 3 months.
4. Performance status Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) ≤ 2.
5. Platelets ≥ 50 billion/l, International Normalized Ratio (INR) < 1.5. Medical correction is allowed, e.g. correction of a high International Normalized Ratio (INR) using vitamin K.
6. Subjects must be willing and able to comply with the procedure, such as agreed follow-up visits.
7. Sexually active men and fertile women must use adequate contraception during this trial
8. Subjects must give written informed consent.

Exclusion Criteria:

1. Coagulation disorder that cannot be corrected.
2. Subjects with a clinically significant cardiac arrhythmia.
3. Concurrent treatment with an investigational medicinal product
4. Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements.
5. Pregnancy or lactation

A medical doctor will always be responsible for final inclusion of the subject.

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: Calcium electroporation; Calcium chloride	Procedure: Calcium electroporation; Areas with Barrett's esophagus high-grade dysplasia will get an injection of calcium chloride in submucosa through an endoscopic system before getting electroporation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 6 weeks after treatment
Registration of treatment related pain through a Visual Analogue Score (VAS)	Second part of safety evaluation which will be registered by VAS score. The VAS score is a scale with values from 0-10, where 0 is no pain and 10 is the worst possible pain.	Day 0 to 6 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
The rate of patient's that have gained from the treatment	Day 0 to 6 weeks after treatment

Collaborators and Investigators

• Sponsor: Michael Patrick Achiam
• Collaborators: Danish Cancer Society
• Investigators: Principal Investigator: Michael Achiam, MD., Ph.D., Rigshospitalet, Department of Surgical Gastroenterology

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2020
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): October 28, 2020

Study Record Updates

• Last Update Posted (Actual): October 28, 2020
• Last Update Submitted That Met QC Criteria: October 27, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Barrett Esophagus; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: BEHGD-10-2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No