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Basal Cell CarcinomaHIFU-BCCNCT05698706

High Intensity Focused Ultrasound (HIFU) Treatment of Basal Cell Carcinoma

A study testing TOOsonix System ONE-M in people with Basal Cell Carcinoma, run by Jacek Calik at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The overall objective of the study is to evaluate the safety and efficacy of treatment of Basal Cell Carcinoma (BCC) using a new modality based on high-intensity focused ultrasound (HIFU). BCC is the most common type of skin cancer in Europe, Australia and the US. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Basal Cell Carcinoma
What is being tested?
TOOsonix System ONE-M
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 sitePoland
Study dates
14 Dec 2022to 14 May 2025
Phase
Interventional
Are there results?
None posted in the registry

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

  • Subjects of each gender aged 18 years or older at the time of informed consent. There is no upper limit of age.
  • Subjects who have received oral and written study information, accepted participation and signed the informed consent document.
  • Subjects who are willing and mentally and physically capable to understand and follow the treatment and follow-up schedule including post-treatment care instructions.
  • Subjects who are willing to have photographs and images taken of the treated lesions to be used anonymously or coded in evaluations and publications.
  • Subjects, who have histologically and clinically verified basal cell carcinoma cancer of thickness not more 2.0 mm measured by ultrasound imaging or histopathological examination.

Who cannot join

  • Subjects who are less than 18 years at the time of informed consent.
  • Subject is pregnant or lactating at time of first treatment
  • Subjects with extensive, invasive or advanced skin cancer when another method in use such as radiotherapy or Mohs' surgery has priority and offers the patient better opportunity of cure.
  • Cancers on anatomical sites where the ultrasound probe cannot be adapted for anatomical reasons
  • Any systemic disease that according to investigator's assessment may interfere with the spontaneous course of a skin cancer.
  • Any condition predisposing to treatment-related adverse effects or complications from the ultrasound treatment.
Show all 10Show fewer
  • Subjects with abnormal scar formation
  • Subjects with impaired wound healing
  • Subjects with any other acute or chronic condition which, in the opinion of the investigator, could interfere with the conduct of the study
  • Subjects undergoing immunosuppressive treatment

Trial locations and contacts

1 site in 1 country.

Jacek Calik, MD, PhD contact

+48 516 222 516

jacek.calik@oldtownclinic.pl

Bartosz Wozniak, MD contact

+48 516 222 516

Poland1 site, 1 recruiting

  • Old Town Clinic

    Wroclaw, 50-127

    Jacek Calik, MD, PhD, +48 516 222 516, jacek.calik@oldtownclinic.pl

    Recruiting

Other trials in Poland

About this study

Official title: High Intensity Focused Ultrasound (HIFU) Treatment of Basal Cell Carcinoma: Efficacy and Safety

The overall objective of the study is to evaluate the safety and efficacy of treatment of Basal Cell Carcinoma (BCC) using a new modality based on high-intensity focused ultrasound (HIFU). BCC is the most common type of skin cancer in Europe, Australia and the US. It accounts for more than 75% of all skin cancer cases in those regions. There are currently more the 14000 BCC cases registrations in Poland every year, and occurrences on a global scale are counted in several millions per year. Given the trend of aging population those numbers will only increase with time. Finding new and more effective treatment methods are therefore highly relevant from both a clinical and socioeconomic perspective. The investigational device used in the study is a system capable of making controlled and targeted thermo-mechanical treatment of small intradermal volumes containing e.g. BCC cells, but without inflicting damage to the surrounding tissue.

The investigation involves an evaluation of the safety and efficacy profile 3 months after a single few-minute treatment. Subsequent follow-up of secondary endpoints is done every third month until the end of the study one year after the treatment.

Being tested
TOOsonix System ONE-M
Keywords
Skin cancer, HIFU, BCC, Dermatology, High Intensity Focused Ultrasound, Dermoscopy
Medical subject headings
Carcinoma, Basal Cell, Skin Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TOOsonix System ONE-MDevice

    Selected BCC sites will be treated using high intensity focused ultrasound

Study groups in NCT05698706
Study groupRoleWhat they receive
De-novo BCC with thickness not more than 2.0 mmExperimentalAreas with de-novo BCC of thickness not more than 2.0 mm (as confirmed by ultrasound imaging or histopathological examination) will be treated by high intensity focused ultrasound
Receives: Device: TOOsonix System ONE-M

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cure rate

    Frequency of complete clearance of BCC after HIFU treatment. Binary output: yes/no

    Measured: 3 months

  2. Severity of short term adverse events

    Safety profile after treatment of basal cell carcinoma measured on a 4-point severity score ranging from No side effects (score 0) to Severe side effects (score 3)

    Measured: 3 months

Secondary outcomes (2)

  1. Severity of adverse events

    Any objective adverse effect or event, local or systemic, related to the treatment and the investigational device (wound and course of wound healing, scar formation, instrumental hazards) measured at 6, 9 and 12 months. Measured on a 4-point severity score ranging from No side effects (score 0) to Severe side effects (score 3)

    Measured: 12 months

  2. Cure rate

    Frequency of complete clearance of BCC after HIFU treatment measured at 6, 9, 12 months after HIFU treatment. Binary output: yes/no

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2023
  2. Study start14 Dec 2022
  3. Primary completion14 May 2025 (estimated)
  4. Study completion14 May 2025 (estimated)

Resources

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
Model description
Single Group Assignment
Masking
None (open label)
Enrolment
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05698706
Sponsor's protocol ID
HIFU-BCC-2023-1
Acronym
HIFU-BCC
Status last verified
Jan 2023
First submitted
16 Jan 2023
Last updated
2 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bove T, Zawada T, Serup J, Jessen A, Poli M. High-frequency (20-MHz) high-intensity focused ultrasound (HIFU) system for dermal intervention: Preclinical evaluation in skin equivalents. Skin Res Technol. 2019 Mar;25(2):217-228. doi: 10.1111/srt.12661. Epub 2019 Jan 8.

    PubMed 30620418

  • Soegaard S, Aarup V, Serup J, Bove T, Zawada T, Jessen A, Poli M. High-frequency (20 MHz) high-intensity focused ultrasound system for dermal intervention: A 12-week local tolerance study in minipigs. Skin Res Technol. 2020 Mar;26(2):241-254. doi: 10.1111/srt.12786. Epub 2019 Sep 20.

    PubMed 31541524

  • Serup J, Bove T, Zawada T, Jessen A, Poli M. High-frequency (20 MHz) high-intensity focused ultrasound: New Treatment of actinic keratosis, basal cell carcinoma, and Kaposi sarcoma. An open-label exploratory study. Skin Res Technol. 2020 Nov;26(6):824-831. doi: 10.1111/srt.12883. Epub 2020 Jun 17.

    PubMed 32557832

  • Calik J, Zawada T, Bove T. Treatment of superficial benign vascular tumors by high intensity focused ultrasound: Observations in two illustrative cases. J Cosmet Dermatol. 2022 Aug;21(8):3371-3379. doi: 10.1111/jocd.14682. Epub 2021 Dec 17.

    PubMed 34921489

  • Calik J, Migdal M, Zawada T, Bove T. Treatment of Seborrheic Keratosis by High Frequency Focused Ultrasound - An Early Experience with 11 Consecutive Cases. Clin Cosmet Investig Dermatol. 2022 Jan 28;15:145-156. doi: 10.2147/CCID.S348106. eCollection 2022.

    PubMed 35125879

Questions about this trial

What is this clinical trial studying?

A study testing TOOsonix System ONE-M in people with Basal Cell Carcinoma, run by Jacek Calik at 1 site in Poland.

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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jacek Calik, MD, PhD (+48 516 222 516, jacek.calik@oldtownclinic.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cure rate (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05698706, which also lists 5 linked publications.

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 2 Feb 2023.

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