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New treatment option for Skin Cancer
Official title Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia
ClinicalTrials.gov ID: NCT04534127
What this study is testing
- What it's testing
- A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people with histopathological confirmation of primary or secondary malignant cutaneous neoplastic lesions, or oral cavity mucosal tumors, or...
- people 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...
You likely can't join if
- 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...
- Any medical or psychiatric illness which in the opinion of the investigator would compromise the patient's ability to tolerate this treatment or...
- 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
See the full eligibility criteria
- people 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...
- people 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.
- people over 18 years old.
- people' ECOG Performance Status Scale is \< 2.
- people' 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...
- people are willing to sign an informed consent form.
- 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...
- 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 treatment 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).
- people not willing to sign an informed consent.
- Women who are pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Jerusalem, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jerusalem, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.