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Calcium Electroporation for Head and Neck Cancer

NCT03051269 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2017-02-13

No results posted yet for this study

Summary

In a phase I protocol to primarily investigate the safety of using calcium combined with electroporation on recurrent head and neck cancers. Secondly, to evaluate tumour response on PET/MRI (positron emission tomography/magnetic resonance imaging), clinical evaluation, biopsies. Thirdly, to evaluate the effect of calcium electroporation compared to electrochemotherapy as well as the patients life-of-quality through questionnaires, EORTC QLQ C-30 and H\&N35 (european organisation for research and treatment of cancer).

Conditions

  • Head Neck Cancer

Interventions

DRUG

Calcium chloride

Tumour site is injected with a solution of 9 mg/ml calcium chloride and afterwards the tumour site is given electroporation to facilitate calcium to enter the cell cytosol.

DEVICE

Electroporation

Performed by single use electrodes attaches to a device called "Cliniporator" provided from IGEA, ITALY.

Sponsors & Collaborators

  • Herlev Hospital

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Irene Wessel · Rigshospitalet, Dept. of Head and Neck Surgery, Copenhagen, Denmark

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2018-12-31
Completion
2019-02-28

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03051269 on ClinicalTrials.gov