NCT05135052

Brief 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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
4 countries

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Jan 2022May 2027

First Submitted

Initial submission to the registry

October 8, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 26, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

January 17, 2022

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2026

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2027

Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

4.5 years

First QC Date

October 8, 2021

Last Update Submit

May 9, 2025

Conditions

Non-melanoma Skin Cancer

Outcome Measures

Primary Outcomes (1)

  • Complete Response (CR) with Modified Visual RECIST tool

    To assess the proportion of lesions achieving complete response (CR) as per MODIFIED VISUAL RECIST criteria

    12 months

Secondary Outcomes (3)

  • SKINDEX-16 QoL Questionnaire

    6 months and 12 months

  • Comfort of Treatment short questionnaire

    14 days

  • cosmetic outcomes by Visual Analogue Scale

    12 months and 24 months

Other Outcomes (1)

  • Safety as assessed by CTCAE v4.0

    24 months

Study Arms (1)

Treatment arm

EXPERIMENTAL

Treatment with Rhenium-SCT, Single treatment.

Device: Rhenium-SCT

Interventions

Rhenium-SCTDEVICE

Rhenium-SCT irradiation device

Treatment arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Genesis Care Health Hub at RNS

Sydney, New South Wales, 2065, Australia

Location

John Flynn Hospital

Tugun, Queensland, 4224, Australia

Location

Hollywood Private

Perth, Western Australia, 6009, Australia

Location

Klinik Ottakring

Ottakring, 1160, Austria

Location

Rostock University Hospital

Rostock, 18057, Germany

Location

Steve Beko Hospital

Pretoria, 0001, South Africa

Location

Kings College Hospital London

London, United Kingdom

Location

Study Officials

  • Gerhard Dr Dahlhoff, MD

    Oncobeta GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2021

First Posted

November 26, 2021

Study Start

January 17, 2022

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

May 15, 2027

Last Updated

May 14, 2025

Record last verified: 2025-05

Locations

DE(1)GB(1)AU(3)ZA(1)