Clinical trial NCT04605419: Calcium Electroporation in Patients With Cell Changes in the Esophagus
Official title: Calcium Electroporation in Patients With Barrett's Esophagus High-grade Dysplasia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Barretts Esophagus With High Grade Dysplasia
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
First posted: 2020-10-28
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with Barrett's esophagus high-grade dysplasia will get calcium electroporation
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Registration of treatment related side effects assessed by CTCAE V 5.0
timeFrame: Day 0 to 6 weeks after treatment
measure: Registration of treatment related pain through a Visual Analogue Score (VAS)
timeFrame: Day 0 to 6 weeks after treatment
Secondary outcomes:
measure: The rate of patient's that have gained from the treatment
timeFrame: Day 0 to 6 weeks after treatment
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Region Hovedstaden
Study officials:
affiliation: Rigshospitalet, Department of Surgical Gastroenterology
name: Michael Achiam, MD., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: