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Brachytherapy

DaRT Seeds for Skin Cancer (DaRT Trial)

N/A

Waitlist Available

Research Sponsored by Alpha Tau Medical LTD.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with cutaneous SCC histologically confirmed

Immunocompromised due to any primary or secondary immunodeficiencies

Must not have

Distant or nodal metastatic disease

Inability to place DaRT seeds into tumor due to inaccessibility by presence of bones or major vessels or vital organs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months following dart insertion

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to enroll 28 participants from multiple centers. The main goal is to see how well patients respond to a treatment called DaRT, which involves injecting radiation-emitting seeds directly into tumors.

Who is the study for?

This trial is for immunocompromised patients with a type of skin cancer called cutaneous squamous cell carcinoma (SCC). Participants should not have had prior radiation therapy in the area to be treated and must be able to attend follow-up visits. Those who are pregnant, breastfeeding, or have other cancers are excluded.

What is being tested?

The study is testing DaRT seeds, a form of radiation treatment for skin cancer. It aims to see how well these seeds can control the growth of SCC when placed directly into tumors. Up to 28 people will join this study at multiple centers.

What are the potential side effects?

Potential side effects from DaRT seed treatment may include local skin reactions like redness or soreness, possible infection at the insertion site, and general fatigue. Long-term side effects are being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My skin cancer is confirmed as squamous cell carcinoma.

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I have a weakened immune system due to a health condition.

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My tumor is 7 cm or smaller in its largest size.

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I have only one cancerous lesion.

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My cancer can be fully treated with DaRT seeds.

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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to distant organs or lymph nodes.

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DaRT seeds cannot be placed in my tumor due to its location near bones or vital organs.

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I have another cancer that is getting worse or needs treatment.

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My cancer is a type of skin cancer that affects moist tissues.

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I have skin cancer that has not been treated yet.

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My largest tumor is bigger than 7 cm.

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My tumor is identified as keratoacanthoma type.

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I have a serious heart condition.

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My cancer has spread to nearby tissues.

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My condition involves extensive nerve involvement.

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My cancer cannot be fully treated with DaRT seeds.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months following dart insertion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months following dart insertion

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months following dart insertion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

objective response rate

Secondary study objectives

Local control

Overall Survival

Progression Free Survival

Other study objectives

Safety Objectives

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: DaRT seedsExperimental Treatment1 Intervention

Diffusing Alpha emitters Radiation (DaRT) treatment to be delivered through radioactive sources inserted into malignant cutaneous squamous cell carcinoma of Immunocompromised Patients

0 / 17Eligibility criteria met