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Trial Title:
A Study of Diffusing Alpha Radiation Therapy for Target Treatments of Malignant Tumors
NCT ID:
NCT05781555
Condition:
Malignant Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Tumor
Malignant Tumor
Cancer
Brachytherapy
Alpha emitting radiation
Compassionate treatment
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Experimental: DaRT seeds
Description:
DaRT source will be inserted using preplanned radiotherapy parameters and reassessed by
volumetric imaging 2-3 weeks after placement and then removed. The study objectives are
to collect data on the general safety and efficacy of DaRT among patients who do not fit
the entry criteria of existing investigational trials.
Arm group label:
DaRT seeds
Summary:
This study is a Compassionate clinical study for the treatment of Malignant Tumors. The
primary endpoint of the study is to assess the frequency, severity and causality of acute
adverse events related to the DaRT treatment. Adverse events will be assessed and graded
according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0. The
secondary endpoint is to assess the tumor response to DaRT treatment assessed using the
Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1) 3 months after DaRT
seed insertion.
Detailed description:
This is an Open label, one arm, prospective study for Compassionate use for the treatment
of malignant tumors. The study objectives are to collect data on the safety and efficacy
of DaRT among patients who do not fit the entry of existing investigational trials.
The primary endpoint of the study is to assess the frequency, severity and causality of
acute adverse events related to the DaRT treatment. Adverse events will be assessed and
graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version
5.0. The secondary endpoint is to assess the tumor response to DaRT treatment assessed
using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1) 3 months
after DaRT seed insertion.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Subjects with any malignancy
- Subjects with a tumor size ≤ 7 centimeters in the longest diameter
- Subjects over 18 years old
- Subjects' life expectancy is more than 6 months
- 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 treatment.
- Subjects/Surrogate decision maker are willing to sign an informed consent form
Exclusion Criteria:
- 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.
- 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/Surrogate decision maker not willing to sign an informed consent.
- Women who are pregnant or breastfeeding.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hadassah Ein Kerem
Address:
City:
Jerusalem
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Aron Popovzer, MD
Email:
Aronp@hadassah.org.il
Contact backup:
Last name:
Hanna Lea Knafou
Phone:
972-2-6776709
Email:
hannalea@hadassah.org.il
Start date:
March 22, 2023
Completion date:
April 2025
Lead sponsor:
Agency:
Alpha Tau Medical LTD.
Agency class:
Industry
Source:
Alpha Tau Medical LTD.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05781555
