Diffusing Alpha Radiation Therapy for Malignant Tumors
This study aims to assess the frequency and severity of acute adverse events in individuals receiving diffusing alpha radiation therapy for malignant tumors.
Experimental: DaRT seeds
Neoplasms
Treatment Study
Summary
Study start date: March 22, 2023
Actual date on which the first participant was enrolled.This study explores a new way to help patients with serious tumors who cannot join other research studies. It looks at a treatment called Diffusing Alpha Radiation Therapy (DaRT), which aims to find out if this method is safe and effective. This study is especially important for those who have limited options for participating in existing trials. By testing DaRT, researchers hope to provide new insights and possibly improve treatment options for these individuals. Participants in this study receive the DaRT treatment, and researchers closely monitor them to see if there are any side effects. The focus is on understanding how often and how severe these side effects might be. Additionally, the study evaluates how well the treatment works by checking the size of the tumors three months after starting DaRT. This involves using a set of criteria known as RECIST to see if the tumors have shrunk. The findings from this study could lead to better treatment strategies for patients with certain types of cancer.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location