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

Primary Purpose

Basal Cell Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
TOOsonix System ONE-M
Sponsored by
Jacek Calik
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Basal Cell Carcinoma focused on measuring Skin cancer, HIFU, BCC, Dermatology, High Intensity Focused Ultrasound, Dermoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. 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

Sites / Locations

  • Old Town ClinicRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

De-novo BCC with thickness not more than 2.0 mm

Arm Description

Areas 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 16, 2023
Last Updated
January 31, 2023
Sponsor
Jacek Calik
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1. Study Identification

Unique Protocol Identification Number
NCT05698706
Brief Title
High Intensity Focused Ultrasound (HIFU) Treatment of Basal Cell Carcinoma
Acronym
HIFU-BCC
Official Title
High Intensity Focused Ultrasound (HIFU) Treatment of Basal Cell Carcinoma: Efficacy and Safety
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2022 (Actual)
Primary Completion Date
May 14, 2025 (Anticipated)
Study Completion Date
May 14, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jacek Calik

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma
Keywords
Skin cancer, HIFU, BCC, Dermatology, High Intensity Focused Ultrasound, Dermoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
De-novo BCC with thickness not more than 2.0 mm
Arm Type
Experimental
Arm Description
Areas 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
Intervention Type
Device
Intervention Name(s)
TOOsonix System ONE-M
Intervention Description
Selected BCC sites will be treated using high intensity focused ultrasound
Primary Outcome Measure Information:
Title
Cure rate
Description
Frequency of complete clearance of BCC after HIFU treatment. Binary output: yes/no
Time Frame
3 months
Title
Severity of short term adverse events
Description
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)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Severity of adverse events
Description
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)
Time Frame
12 months
Title
Cure rate
Description
Frequency of complete clearance of BCC after HIFU treatment measured at 6, 9, 12 months after HIFU treatment. Binary output: yes/no
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacek Calik, MD, PhD
Phone
+48 516 222 516
Email
jacek.calik@oldtownclinic.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Bartosz Wozniak, MD
Phone
+48 516 222 516
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacek Calik, MD, PhD
Organizational Affiliation
Old Town Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Old Town Clinic
City
Wrocław
ZIP/Postal Code
50-127
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacek Calik, MD, PhD
Phone
+48 516 222 516
Email
jacek.calik@oldtownclinic.pl

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30620418
Citation
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.
Results Reference
background
PubMed Identifier
31541524
Citation
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.
Results Reference
background
PubMed Identifier
32557832
Citation
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.
Results Reference
background
PubMed Identifier
34921489
Citation
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.
Results Reference
background
PubMed Identifier
35125879
Citation
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.
Results Reference
background
Links:
URL
https://oldtownclinic.pl/en/
Description
Website of Old Town Clinic

Learn more about this trial

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

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