- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04534127
Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia
A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia
Study Overview
Status
Intervention / Treatment
Detailed Description
This will be a prospective, open label, single arm, controlled study, assessing the safety and efficacy of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds inserted into the tumor.
This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients.
Superficial lesions with histopathological confirmation of malignancy will be treated using DaRT seeds.
Reduction in tumor size 70 days after DaRT insertion will be assessed. Safety will be assessed by the incidence, severity and frequency of all Adverse Events (AE).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Liron Dimnik
- Phone Number: +972-2-373-7000
- Email: LironD@alphatau.com
Study Locations
-
-
-
Jerusalem, Israel, 91120
- Recruiting
- Sharett institute, Hadassah Medical Center - Ein-Kerem
-
Contact:
- Aron Popovtzer, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subjects with histopathological confirmation of primary or secondary malignant cutaneous neoplastic lesions, or oral cavity mucosal tumors, or superficial soft tissue sarcoma. Confirmation obtained within 6 months of planned treatment.
- Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
- Targetable lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds
- Brachytherapy indication validated by a multidisciplinary team
- Patients who have either failed first-line treatment, or are medically unfit for standard of care (surgery, external-beam radiation therapy or chemotherapy), or refuse standard of care.
- Measurable disease according to RECIST v1.1.
- Subjects over 18 years old.
- Subjects' ECOG Performance Status Scale is < 2.
- Subjects' life expectancy is more than 6 months.
- Platelet count ≥100,000/mm3.
- WBC ≥ 3500/μl, granulocyte ≥ 1500/μl
- AST and ALT ≤ 2.5 X ULN
- International normalized ratio of prothrombin time ≤1.8.
- Creatinine ≤1.9 mg/dL. Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after brachytherapy.
- Subjects are willing to sign an informed consent form.
Exclusion Criteria:
- Subject has a tumor of Keratoacanthoma histology.
- Known hypersensitivity to any of the components of the treatment.
- Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.
- Any medical or psychiatric illness which in the opinion of the investigator would compromise the patient's ability to tolerate this treatment or interfere with the study endpoints.
- Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids
- Patient requires treatment which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT
- Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.
- Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.
- High probability of protocol non-compliance (in opinion of investigator).
- Subjects not willing to sign an informed consent.
- Women who are pregnant or breastfeeding.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DaRT Seeds
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
|
An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds.
The seeds release by recoil into the tumor short-lived alpha-emitting atoms.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor response to DaRT
Time Frame: 9-11 weeks post DaRT insertion
|
Assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
|
9-11 weeks post DaRT insertion
|
Adverse Events
Time Frame: Up to 24 Months
|
The incidence, frequency, severity and causality of acute adverse events related to the DaRT treatment according to Common Terminology and Criteria for adverse events (CTCAE) version 5.0.
|
Up to 24 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in tumor volume
Time Frame: 9-11 weeks post DaRT insertion
|
Based on imaging
|
9-11 weeks post DaRT insertion
|
DaRT seeds placement
Time Frame: 1 Day of procedure
|
Assessment by localization of the DaRT seeds in the tumor using CT imaging on the day of DaRT insertion
|
1 Day of procedure
|
Change in quality of life
Time Frame: Day 15, Day 30, Day 70, Day 180 post DaRT insertion
|
Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skindex-16 questionnaire score
|
Day 15, Day 30, Day 70, Day 180 post DaRT insertion
|
Change in quality of life
Time Frame: Day 30, Day 70, Day 180 post DaRT insertion
|
Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skin Cancer Index (SCI) questionnaire score
|
Day 30, Day 70, Day 180 post DaRT insertion
|
Progression Free Survival
Time Frame: 24 months post DaRT insertion
|
Time elapsed from response to disease progression
|
24 months post DaRT insertion
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: Up to 24 Months
|
All Adverse Events (AE) related and unrelated to the study treatment
|
Up to 24 Months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aron Popovtzer, Sharett institute, Hadassah University Hospital - Ein-Kerem
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTP-CMN-02_
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Skin Cancer
-
University of HawaiiVA Palo Alto Health Care SystemCompletedCancer, Other Than Non-melanoma Skin CancerUnited States
-
EnlundCompletedBreast Cancer | Skin Cancer | Colo-rectal CancerSweden
-
McMaster UniversityRecruitingSkin Cancer, Basal Cell Skin Cancer Skin Cancer, Non-Melanoma Skin Cancers - Squamous Cell Carcinoma Patient SatisfactionCanada
-
SciBase ABRecruitingKeratinocyte Skin CancerGermany
-
Rutgers, The State University of New JerseyCompleted
-
University of MichiganBlue Cross Blue Shield of Michigan FoundationCompletedSkin Cancer PreventionUnited States
-
Fox Chase Cancer CenterNational Cancer Institute (NCI)CompletedSkin Cancer PreventionUnited States
-
Xoft, Inc.Eminence Clinical Research, Inc.UnknownNonmelanoma Skin CancerUnited States
-
Assistance Publique - Hôpitaux de ParisRecruitingSkin Cancer, Non-MelanomaFrance
-
Technische Universität DresdenCompletedNon-melanoma Skin CancerGermany
Clinical Trials on Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
-
Alpha Tau Medical LTD.RecruitingSkin Cancer | Mucosal Neoplasm of Oral Cavity | Soft Tissue NeoplasmIsrael
-
Alpha Tau Medical LTD.European Organisation for Research and Treatment of Cancer - EORTCNot yet recruitingHead and Neck Squamous Cell Carcinoma | Squamous Cell CarcinomaIsrael
-
Alpha Tau Medical LTD.Active, not recruitingSkin Cancer | Mucosal Neoplasm of Oral Cavity | Soft Tissue NeoplasmIsrael
-
Alpha Tau Medical LTD.Not yet recruitingBreast Cancer | Breast Carcinoma | Recurrent Breast CancerIsrael
-
Alpha Tau Medical LTD.RecruitingProstate AdenocarcinomaIsrael
-
Alpha Tau Medical LTD.CompletedSkin Squamous Cell CarcinomaItaly
-
Alpha Tau Medical LTD.RecruitingSkin Cancer | Cutaneous Tumor | Cutaneous MetastasisFrance
-
Alpha Tau Medical LTD.RecruitingSkin Cancer | Mucosal Neoplasm of Oral Cavity | Soft Tissue NeoplasmItaly
-
Alpha Tau Medical LTD.CompletedSquamous Cell CarcinomaIsrael
-
Alpha Tau Medical LTD.RecruitingLung Cancer | Recurrent Lung CancerIsrael