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New treatment option for Skin Cancer
Official title Alpha Radiation Emitters Device (DaRT) for the Treatment of of Malignant Cutaneous Tumors
ClinicalTrials.gov ID: NCT04068155
What this study is testing
- What it's testing
- A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for Malignant Cutaneous Tumors
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 newly diagnosed (Cohort A) or locally recurrent (Cohort B) malignant cutaneous lesions of the following...
- Lentigo maligna melanoma (Dubreuilh melanoma)
- Carcinosarcoma
- Acceptable tumor locations include the following:
- Skin (facial, scalp, extremities, torso)
You likely can't join if
- Subject has a tumor with histology of one of the following:
- Keratoacanthoma
- Merkel cell carcinoma
- Sarcoma other than carcinosarcoma
- Metastatic disease (according to the TNM staging system - M1 patients are excluded)
- Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled...
See the full eligibility criteria
- people with histopathological confirmation of newly diagnosed (Cohort A) or locally recurrent (Cohort B) malignant cutaneous lesions of the following histopathologies:
- Lentigo maligna melanoma (Dubreuilh melanoma)
- Carcinosarcoma
- Acceptable tumor locations include the following:
- Skin (facial, scalp, extremities, torso)
- Lips
- Eyelids
- people with a tumor size ≤ 7 centimeters in the longest diameter.
- Target lesion technically amenable for full tumor coverage with the Alpha DaRT seeds.
- 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.
- International normalized ratio of prothrombin time ≤1.8.
- Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test.
- people are willing to sign an informed consent form
- Subject has a tumor with histology of one of the following:
- Keratoacanthoma
- Merkel cell carcinoma
- Sarcoma other than carcinosarcoma
- Metastatic disease (according to the TNM staging system - M1 patients are excluded)
- Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.).
- Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
- 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.
- 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
- Grenoble, France
- Lyon, France
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 Grenoble, France; Lyon, France. 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.