Non-melanoma Skin CancerEPIC-SkinNCT05135052
Rhenium-Skin Cancer Therapy (SCT) for the Treatment of Non-Melanoma Skin Cancer.
A study testing Rhenium-SCT in people with Non-melanoma Skin Cancer, run by OncoBeta Therapeutics at 7 sites in 5 countries.
Trial summary
Efficacy of Personalised Irradiation with Rhenium-Skin Cancer Therapy (SCT) for the treatment of non-melanoma skin cancer; a phase IV multi-centre, international, open label, single arm study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-melanoma Skin Cancer
- What is being tested?
- Rhenium-SCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 7 sitesin 5 countries
- Study dates
- 17 Jan 2022to 15 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage I or II BCC or SCC (SCC Well to Moderately Differentiated), and clinically node negative disease
- Confirmed Histology, and with depth of lesion noted
- Subjects with up to 3 lesions suitable to enter the study (subjects with more than 3 lesions are not excluded from the study, however 3 target lesions are determined for study evaluation only.)
- Subjects able and willing to comply with the requirements of the study
- Age >=18 years
- Informed Consent signed by the subject consenting to undergo the study
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- Lesions up to 8cm2
- Lesions with a depth up to 3mm confirmed on biopsy report AND deemed appropriate clinically by treating clinician
- Subjects who are not deemed suitable for surgery, for example due to tumour location, performance status or other comorbidities as deemed relevant by the treating clinician
- Patients who may have declined Surgery and/or fractionated Radiation Therapy
Who cannot join
- Inability to personally provide written informed consent or to understand and collaborate throughout the study
- Inability or unwillingness to comply with study requirements
- Prior treatment with surgery or radiation therapy for their target lesion(s)
- Depth of lesion greater than 3mm as defined by Biopsy and/or clinical assessment
- Lupus and Scleroderma
- Basal cell naevus syndrome, xeroderma, vitiligo and albinism
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- Prior laser at the tumour site
- Malignant melanoma systemic therapy ongoing
- Any ongoing treatment for malignancy, or in the last 4 weeks prior to study entry
- A tumour affecting nerves or bony structures
- Clinical concern of metastatic disease
- Pregnancy and/or Lactation
- Pathological exclusions: Perineural Invasion, Lymphovascular invasion
- Anatomical exclusions: NMSC's of the Medial canthus, eyelid margin (upper and lower), Vermillion lip
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
Australia3 sites
Hollywood Private
Perth, Western Australia, 6009
Genesis Care Health Hub at RNS
Sydney, New South Wales, 2065
John Flynn Hospital
Tugun, Queensland, 4224
About this study
Official title: Efficacy of Personalised Irradiation With Rhenium-Skin Cancer Therapy (SCT) for the Treatment of Non-Melanoma Skin Cancer: A Phase IV, Multi-Centre, International, Open-Label, Single Arm Study.
Efficacy of Personalised Irradiation with Rhenium-Skin Cancer Therapy (SCT) for the treatment of non-melanoma skin cancer; a phase IV multi-centre, international, open label, single arm study.
- Conditions
- Non-melanoma Skin Cancer
- Being tested
- Rhenium-SCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhenium-SCTDevice
Rhenium-SCT irradiation device
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Treatment with Rhenium-SCT, Single treatment. Receives: Device: Rhenium-SCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (CR) with Modified Visual RECIST tool
To assess the proportion of lesions achieving complete response (CR) as per MODIFIED VISUAL RECIST criteria
Measured: 12 months
Secondary outcomes (3)
SKINDEX-16 QoL Questionnaire
The QoL questionnaire will be scored according to the author's instructions. Change from baseline in score will be calculated. Descriptive statistics will be presented for actual score and change from baseline by timepoint, overall and by tumour type (BCC/SCC).
Measured: 6 months and 12 months
Comfort of Treatment short questionnaire
Comfort of treatment assessed using a short questionnaire completed by subjects post treatment with Rhenium-SCT. The frequency (and percentage) of subjects reporting each option for each question will be presented.
Measured: 14 days
cosmetic outcomes by Visual Analogue Scale
Cosmetic outcome assessed by subject and Clinician, using Visual Analogue Scale. Descriptive statistics will be presented overall and by tumour type (BCC or SCC). A mixed model will be fitted with Visual Analogue Scale as the outcome variable. Tumour type and tumour stage will be included as factors. Other relevant prognostic factors assessed at Baseline will be included. From the model the adjusted mean score will be obtained and presented with 95% confidence limits. Adjusted mean score will be estimated overall and by tumour type.
Measured: 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start17 Jan 2022
- Primary completion15 Jul 2026 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-melanoma Skin CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OncoBeta Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerhard Dr Dahlhoff, MD, Study director, Oncobeta GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135052
- Sponsor's protocol ID
- OB-RHSCT-101
- Acronym
- EPIC-Skin
- Status last verified
- May 2025
- First submitted
- 8 Oct 2021
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Personalised Irradiation With Rhenium-Skin Cancer Therapy (SCT) for the Treatment of Non-Melanoma Skin Cancer: A Phase IV, Multi-Centre, International, Open-Label, Single Arm Study.
- ClinicalTrials.gov ID
- NCT05135052
- Acronym / sponsor ID
- EPIC-Skin / OB-RHSCT-101
- Conditions
- Non-melanoma Skin Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- OncoBeta TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 26 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacy of Personalised Irradiation with Rhenium-Skin Cancer Therapy (SCT) for the treatment of non-melanoma skin cancer; a phase IV multi-centre, international, open label, single arm study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: Rhenium-SCTTreatment with Rhenium-SCT, Single treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Stage I or II BCC or SCC (SCC Well to Moderately Differentiated), and clinically node negative disease
- Confirmed Histology, and with depth of lesion noted
- Subjects with up to 3 lesions suitable to enter the study (subjects with more than 3 lesions are not excluded from the study, however 3 target lesions are determined for study evaluation only.)
- Subjects able and willing to comply with the requirements of the study
- Age >=18 years
Key exclusion criteria (14 listed)
- Inability to personally provide written informed consent or to understand and collaborate throughout the study
- Inability or unwillingness to comply with study requirements
- Prior treatment with surgery or radiation therapy for their target lesion(s)
- Depth of lesion greater than 3mm as defined by Biopsy and/or clinical assessment
- Lupus and Scleroderma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhenium-SCTRhenium-SCT irradiation device | Device | Treatment arm |
Primary outcome
Complete Response (CR) with Modified Visual RECIST tool
Time frame: 12 months
To assess the proportion of lesions achieving complete response (CR) as per MODIFIED VISUAL RECIST criteria
3 secondary outcomes
SKINDEX-16 QoL Questionnaire
Time frame: 6 months and 12 months
Comfort of Treatment short questionnaire
Time frame: 14 days
cosmetic outcomes by Visual Analogue Scale
Time frame: 12 months and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Dr Dahlhoff, MD study director
Oncobeta GmbH
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhenium-SCT in people with Non-melanoma Skin Cancer, run by OncoBeta Therapeutics at 7 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, Austria, Germany, South Africa, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (CR) with Modified Visual RECIST tool (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.