Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
7 participants
INTERVENTIONAL
2013-08-31
2018-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Calcium electroporation
The keloid will be treated with intratumoral injection of calcium chloride followed by electrotransfer. It is a once only treatment.
Calcium chlorid concentration is 9 mg/ml Total dose is 0,5ml/cm3 tumor volume.
Calcium chloride
Interventions
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Calcium chloride
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient should have been offered standard treatment.
* At least 8 weeks since other keloid treatment.
* Performance status \<2 (ECOG).
* Platelet count \>50 mia/l
* International Normalized Ratio (INR) \<1,2.
* Age \>18.
* Patient should be able to understand participants information.
* Signed, informed consent.
Exclusion Criteria
* Pregnancy or lactation.
* Participation in other clinical trial involving experimental drugs or participation in a clinical trial within 4 weeks before study treatment.
18 Years
ALL
No
Sponsors
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Herlev Hospital
OTHER
Responsible Party
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Julie Gehl
Medical doctor
Principal Investigators
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Julie Gehl, MD
Role: PRINCIPAL_INVESTIGATOR
University of Copenhagen
Locations
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Department of Oncology, Copenhagen University hospital, Herlev
Herlev, , Denmark
Countries
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Other Identifiers
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AA1310
Identifier Type: -
Identifier Source: org_study_id
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