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New treatment option for Squamous Cell Carcinoma
Official title Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous SCC for Immunocompromised Patients
ClinicalTrials.gov ID: NCT06615635
What this study is testing
- What it's testing
- This is a multi-center clinical study enrolling up to 28 participants. The primary objectives are to determine the objective response rate (ORR) established by the confirmed best overall response (BOR) following intratumoral administration of DaRT - Diffusing Alpha-Emitters Radiation Therapy.
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
- 1\. Patients with cutaneous SCC histologically confirmed 2. Histopathological confirmation within 6 months of enrollment provided no tumor treatment...
- Platelets ≥100,000 mm3,
- Total bilirubin ≤ 1.5xULN,
- AST ≤2.5xULN,
- SGOT ≤2.5xULN,
You likely can't join if
- 1\. Distant or nodal metastatic disease (according to the TNM staging system - N+ or M1 patients are excluded). 2\. T4 disease 3. extensive PNI 4...
- Antineoplastic systemic chemotherapy or biological therapy
- Immunotherapy
- Investigational agents other than the study intervention
- Radiation therapy
- Live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial. 10\. Longest tumor diameter \>7 cm. 11...
See the full eligibility criteria
- 1\. Patients with cutaneous SCC histologically confirmed 2. Histopathological confirmation within 6 months of enrollment provided no tumor treatment occurred between the biopsy and enrollment 3. Immunocompromised due to...
- Platelets ≥100,000 mm3,
- Total bilirubin ≤ 1.5xULN,
- AST ≤2.5xULN,
- SGOT ≤2.5xULN,
- SGPT ≤2.5xULN,
- Alkaline Phosphatase ≤2.5xULN.
- Creatinine Clearance ≥30 ml/min.
- INR or Prothrombin time ≤1.5xULN.
- 1\. Distant or nodal metastatic disease (according to the TNM staging system - N+ or M1 patients are excluded). 2\. T4 disease 3. extensive PNI 4. Previously untreated cutaneous SCC 5. Mucosal SCC. 6. Inability to fully...
- Antineoplastic systemic chemotherapy or biological therapy
- Immunotherapy
- Investigational agents other than the study intervention
- Radiation therapy
- Live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial. 10\. Longest tumor diameter \>7 cm. 11. Tumor with keratoacanthoma histology. 12. Known hypersensitivity to...
The study team makes the final eligibility decision.
Where it's taking place
- Gilbert, Arizona, United States
- Phoenix, Arizona, United States
- Boca Raton, Florida, United States
- Hollywood, Florida, United States
- Palm Beach, Florida, United States
- Poinciana, Florida, United States
- Atlanta, Georgia, United States
- Rochester, Minnesota, United States
- Cooperstown, New York, United States
- 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 Gilbert, Arizona, United States; Phoenix, Arizona, United States; Boca Raton, Florida, United States; Hollywood, Florida, United States; Palm Beach, Florida, United States; Poinciana, Florida, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.