Calcium Electroporation in Patients With Cell Changes in the Esophagus

Barretts Esophagus With High Grade Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04605419
• Other study ID #: BEHGD-10-2020
• Status: Recruiting
• Phase: Phase 1
• Start date: October 7, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: October 2020
• Source: Rigshospitalet, Denmark
• Contact: Michael Achiam, MD., Ph.D.
• Phone: +45 35 45 04 41
• Email: Michael.Patrick.Achiam.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Barrett Esophagus
• Barretts Esophagus With High Grade Dysplasia

Intervention

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

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen	Region Hovedstaden

Sponsors (2)

Lead Sponsor	Collaborator
Michael Patrick Achiam	Danish Cancer Society

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	The rate of patient's that have gained from the treatment		Day 0 to 6 weeks after treatment