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HIFU for Treatment of Non-nodular and Recurrent BCC (BCC-HIFU2101)

Primary Purpose

Carcinoma, Basal Cell

Status

Recruiting

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

TOOsonix system ONE-M

About this trial

This is an interventional treatment trial for Carcinoma, Basal Cell focused on measuring Basal cell carcinoma, BCC, Skin cancer, High intensity focused ultrasound, HIFU, Dermatology

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 either as newly diagnosed non-nodular cancer (one group) or as a recurrent cancer in a local site (another group) previously treated with any method practiced in dermatology clinics, hospital or the primary sector. Tumors of thickness more than 2.0 mm measured by ultrasound or OTC are considered of the "nodular" type. Thus, only tumors of thickness 2.0mm and less are included.

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 the basal cell carcinoma under study located nearby (<5 cm) an implant or a site injected with a dermal filler or paraffin.
Subjects with any other acute or chronic condition which, in the opinion of the investigator, could interfere with the conduct of the study.

Sites / Locations

Bispebjerg HospitalRecruiting
Roskilde HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Areas with de-novo or recurrent BCC

Arm Description

Areas with non-nodular de-novo or recurrent BCC area will be treated by high intensity focused ultrasound.

Outcomes

Primary Outcome Measures

Cure Rate

Cure rate of basal cell carcinoma (de novo or recurrences after conventional treatments, two groups) following treatment with the investigational device. Measured as a binary Yes/No output.

Severity of short term treatment side effects

Safety profile after treatment of basal cell carcinoma (de novo or recurrences after conventional treatments, two groups) following treatment with the investigational device. Measured on a 4-point severity score ranging from No side effects (score 1) to Severe side effects (score 4).

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 1) to Severe side effects (score 4).

Cure Rate

Cure rate of basal cell carcinoma (de novo or recurrences after conventional treatments, two groups) following treatment with the investigational device measured at 6, 9 and 12 months. Measured as a binary Yes/No output.

Full Information

NCT ID

NCT05133427

First Posted

October 29, 2021

Last Updated

March 21, 2022

Sponsor

Joergen Serup

Collaborators

Zealand University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05133427

Brief Title

HIFU for Treatment of Non-nodular and Recurrent BCC

Acronym

BCC-HIFU2101

Official Title

High-Intensity Focused Ultrasound (HIFU) for Treatment of Non-nodular and Recurrent Basal Cell Carcinomas of the Skin: Efficacy and Safety.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 21, 2022 (Actual)

Primary Completion Date

December 1, 2024 (Anticipated)

Study Completion Date

December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Joergen Serup

Collaborators

Zealand University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The overall objective of this study is to demonstrate the safety and efficacy of removal of Basal Cell Carcinoma (BCC) using a new investigational equipment based on high-intensity focused ultrasound. Basal cell carcinoma is the most common cancer in Europe, Australia and the U.S.A. The general upwards age shift in the population in these regions is expected to be accompanied by an increase in the incidence of this type of cancer. There are currently more the 20.000 BCC registrations in Denmark every year, and occurrences on a global scale are counted in several tens of millions per year. Finding new and more effective treatment methods are therefore highly relevant from both a clinical and socioeconomic perspective. The investigational device used in the investigation is a Danish developed 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 3-5 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

Carcinoma, Basal Cell

Keywords

Basal cell carcinoma, BCC, Skin cancer, High intensity focused ultrasound, HIFU, Dermatology

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

The study is a multicenter (two-center), open-label study in humans (hospital outpatients). The study is not comparative with respect to the two study groups; however, it is aimed to pool data if the study groups are statistically comparable. The investigation is performed prior to CE mark to confirm safety and performance of the System ONE-M device when used as intended, i.e. as an non-invasive method to remove non-nodular basal cell carcinoma by 20 MHz high intensity focused ultrasound.

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Areas with de-novo or recurrent BCC

Arm Type

Experimental

Arm Description

Areas with non-nodular de-novo or recurrent BCC area will be treated by high intensity focused ultrasound.

Intervention Type

Device

Intervention Name(s)

TOOsonix system ONE-M

Intervention Description

All selected BCC areas will be treated by high intensity focused ultrasound

Primary Outcome Measure Information:

Title

Cure Rate

Description

Cure rate of basal cell carcinoma (de novo or recurrences after conventional treatments, two groups) following treatment with the investigational device. Measured as a binary Yes/No output.

Time Frame

3 months

Title

Severity of short term treatment side effects

Description

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Severity of adverse events

Description

Time Frame

12 months

Title

Cure Rate

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 either as newly diagnosed non-nodular cancer (one group) or as a recurrent cancer in a local site (another group) previously treated with any method practiced in dermatology clinics, hospital or the primary sector. Tumors of thickness more than 2.0 mm measured by ultrasound or OTC are considered of the "nodular" type. Thus, only tumors of thickness 2.0mm and less are included. 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 the basal cell carcinoma under study located nearby (<5 cm) an implant or a site injected with a dermal filler or paraffin. Subjects with any other acute or chronic condition which, in the opinion of the investigator, could interfere with the conduct of the study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Joergen V Serup, Professor

Phone

+45-2142 4888

Joergen.Vedelskov.Serup@regionh.dk

First Name & Middle Initial & Last Name or Official Title & Degree

Gabrielle R Vinding, Phd

Phone

+45-2714 4207

GRV@regionsjaelland.dk

Facility Information:

Facility Name

Bispebjerg Hospital

City

Copenhagen

State/Province

Hovedstaden

ZIP/Postal Code

2400

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joergen V Serup, Professor

Joergen.Vedelskov.Serup@regionh.dk

Facility Name

Roskilde Hospital

City

Roskilde

State/Province

Sjaelland

ZIP/Postal Code

4000

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gabrielle R Vinding, Phd

Phone

+45-2714 4207

GRV@regionsjaelland.dk

First Name & Middle Initial & Last Name & Degree

Jeanette Kaa, Phd

First Name & Middle Initial & Last Name & Degree

Gregor BE Jemec, Professor

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

HIFU for Treatment of Non-nodular and Recurrent BCC

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