E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Basal cell carcinoma in adults |
Basalcellekræft hos voksne |
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E.1.1.1 | Medical condition in easily understood language |
Regular skin cancer also called basal cell carcinoma |
Almindelig hudkræft, også kaldet basalcellekræft |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to investigate the microvascular changes in BCC during non-surgical treatment using D-OCT. The principally different mechanisms of action with either MAL-PDT or electrochemotharpy will be compared to each other by means of D-OCT. |
Forsøget har til formal at undersøge behandlingseffekten på de mikroskopiske blodkar i basalcellekræft med ikke-kirurgisk behandling. Ændringerne i blodkarrenes struktur og tæthed anvendes til at vurdere, om man tidligere kan forudsige behandlingseffekten. To forskellige behandlinger evalueres. En konventionel, fotodynamisk terapi og én eksperimentel behandling, elektrokemoterapi med bleomycin. |
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E.2.2 | Secondary objectives of the trial |
To assess any predictors in clinical outcome of BCC undergoing non-surgical therapy by means of using D-OCT, futhermore to evaluate the Quality of Life in patients undergoing these treatments. |
At vurdere eventuelle forudsigeligheder i klinisk effect af non-kirurgisk behandling af BCC ved hjælp af D-OCT samt livskvalitet før og efter behandling. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
General inclusion criteria: 1. Patients must be mentally capable of understanding the information given. 2. Patients must give written informed consent. 3. Clinically diagnosed low-risk BCC on the trunk and ekstremities, diameter < 2 cm. 4. Men or women aged at least 18 years. 5. Cases reviewed by a dermatological specialist. 6. ASA class I-III (Classification of the American Society of Anesthesiology) 7. No prior history of sensitivity or allergies to the chosen treatment drug. 8. Patients must initially agree to have a punhbiopsy performed at 1-year follow-up 9. A female of non-childbearing potential: (i.e.i.e., physiologically incapable of becoming pregnant) is eligible in the study if she: • Has had a hysterectomy. • Has had a bilateral oophorectomy (ovariotomy). • Has had a bilateral tuba ligation. • Is post menopausalpost-menopausal: Post menopausalPost-menopausal definition: Patients not using hormone replacement must have experienced total cassation of menses for one year and be greater than 45 years in age, or, in questionable cases have a follicle stimulation hormone (FSH) value 40 mIU/mL and an estradiol value 40 pg/mL (<140 pmol/L).
Patients using Hormone Replacement Therapy must have experienced total cessation of menses > 1 year and be greater than 45 years of age or have had documented evidence of menopause based on FSH and estradiol concentrations prior to Hormone replacement therapy. 10 A female of childbearing potential: is eligible in the study only if she has had a negative serum or urine pregnancy test within 2 weeks prior to the electroporation treatment. 11 A woman of childbearing potential and men: Are eligible upon agreement to use adequate contraception since signing the informed consent form until at least 6 months after the last electroporation therapy cycle. The investigator or designated associate is requested to advise the patient how to achieve adequate birth control. |
Generelle inklusionskriterier: 1. Patienterne skal være habile, dvs. i stand til at forstå den givne information. 2. Patienterne skal give informeret skriftligt samtykke 3. Det skal være klinisk diagnosticeret lav-risiko basalcellekræft på over- og underkrop, arme eller ben. 4. Mænd og kvinder over 18 år. 5. Patienterne skal være undersøgt af en speciallæge i dermatologi. 6. ASA klasse I-III (Se vedhæftede beskrivelse af ASA-klasser)* 7. Ingen tidligere overfølsomhed eller allergier over for den valgte behandling. 8. Patienterne må initialt give samtykke til at få foretaget en hudbiopsi ved 1 års opfølgningen (samtykke til denne biopsi kan altid tilbagetrækkes senere af patienten). 9. Kvinder, som ikke kan få børn (ikke er i stand til at blive gravide) er egnede til at indgå i studiet hvis mindst ét af følgende kriterier er opfyldt: - De har fået fjernet livmoderen - Har fået fjernet begge æggestokke - Er blevet steriliseret med overskæring eller klipsning af begge æggeledere. - Er gået i overgangsalderen 10. Kvinder som kan få børn: er egnede til at indgå i studiet, hvis hun har fået en negativ graviditetstest målt i blodprøve eller urin inden for 2 uger før behandlingen. 11. Kvinder som kan få børn og mænd: er egnede til at indgå i studiet, hvis mande går med til at beskytte sig mod graviditet i mindst 6 måneder efter behandlingen. Det er den forsøgsansvarliges ansvar at rådgive patienten omkring beskyttelse mod graviditet
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E.4 | Principal exclusion criteria |
Exclusion criteria for ECT-treatment 1. Coagulation disorder or anticoagulant treatment with INR >1.5. 2. Platelets <70000/mm3 3. Cardiac history with manifest cardiac arrhythmia or previous cardiac events in patients with BCC on the anterior chest wall. 4. Patients with ICD or pacemaker units with BCC on the anterior chest wall. 5. Patients with epilepsy. 6. Pregnancy or lactation/breastfeeding. 7. Patients with known Hepatitis B/C or HIV infection. 8. Concurrent treatment with an investigational medicinal product. 9. 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 recruitments. 10. Patients with Contraindications for bleomycin: • Acute pulmonary infection. • Medical history of severe pulmonary disease. • Previous allergic reactions to bleomycin. • Previous cumulative dose of bleomycin exceeding 400 000 IU/m2. 11. Patients registered in the Danish “Vævsanvendelsesregister”
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Specifikke eksklusionskriterier for elektrokemoterapi 1. Sygdom eller tilstand, der forringer blodet evne til at størkne 2. Sygehistorie med hjerterytmeforstyrrelse eller tidligere anfald af hjertesygdom hos patienter med basalcellekræft på forsiden af brystvæggen. 3. Patienter med pacemaker* eller ICD (en anden type pacemaker) på forsiden af brystvæggen. 4. Patienter med epilepsi. 5. Gravide og ammende kvinder. 6. Patienter med Hepatitis B/C eller HIV infektion. 7. Patienter i behandling med anden medicin til klinisk afprøvning. 8. Patienter som har andre nuværende eller tidligere sygdomme eller tilstande som efter forsøgsansvarliges vurdering gør, at patienten ikke kan deltage i studiet eller opfylde de krav, der stilles i studiet. 9. Patienter med kontraindikationer til bleomycin, herunder: - Akut lungeinfektion - Sygehistorie med svær lungesygdom - Tidligere allergisk reaktion mod bleomycin - Tidligere total dosis af bleomycin over 400.000 enheder/m2 10. Patienter, der er registreret i vævsanvendelsesregisteret
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective is to investigate the microvascular changes in BCC during non-surgical treatment using D-OCT. The occlusion (diameter of the widest vessel at a given depth), reduction of the proportion of patent vessels at 0, 150, 300 and 500 micrometer depth will be assessed relative to pre-treatment and posttreatment levels according to visits.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
30 minuttes after treatment, 1 day, 1 week, 3 months and one year |
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E.5.2 | Secondary end point(s) |
To assess any predictors (thickness, density, attenuation and vascular pattern) in clinical outcome of of BCC undergoing non-surgical therapy by means of using D-OCT. To evaluate the quality of life in patients undergoing these treatments by SCQoL. To evaluate hyperpigmentation as a side effect of bleomycin |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
30 minuttes after treatment, 1 day, 1 week, 3 months and one year |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The last visit of the last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |