DaRT seeds for Squamous Cell Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Banner Health MD Anderson Phoenix, Gilbert, AZSquamous Cell CarcinomaDaRT seeds - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer treatment called DaRT. The goal is to find out how well it works and how safe it is.

Eligible Conditions
  • Squamous Cell Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: Up to 12 months following DaRT insertion

Month 6
Duration of Response
Week 52
Objective Response Rate
Week 52
Patients Quality of Life Assessment
Day 14
User experience
Month 12
Progression Free Survival
Month 12
DaRT-related Adverse Events
Overall Survival
Time of Local Control
Month 12
Overall Duration of Response (O-DOR)

Trial Safety

Trial Design

1 Treatment Group

DaRT seeds
1 of 1

Experimental Treatment

86 Total Participants · 1 Treatment Group

Primary Treatment: DaRT seeds · No Placebo Group · N/A

DaRT seeds
Device
Experimental Group · 1 Intervention: DaRT seeds · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months following dart insertion

Who is running the clinical trial?

Alpha Tau Medical LTD.Lead Sponsor
19 Previous Clinical Trials
701 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 24 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are able to have a CT scan.
You can only have one abnormal growth or tumor being studied.
You have a type of skin cancer called cutaneous SCC that has come back after first-line treatment. Surgery and radiation therapy are not options for you, and there is no other known curative treatment available.

Frequently Asked Questions

What is the objective of this investigation?

"This trial will assess the Duration of Response and other objectives, such as DaRT-related Adverse Events (evaluated using CTCAE v5), Patients Quality Of Life Assessment via Skin Cancer Index and Skindex-16 questionnaires, and Time of Local Control. This evaluation period is expected to last from Day 14 until 52 weeks." - Anonymous Online Contributor

Unverified Answer

Are researchers currently seeking participants for this experiment?

"According to the data on clinicaltrials.gov, this medical trial is still enrolling participants. Initially posted on September 21st 2022 and subsequently updated in November of that same year, further subjects are being sought for inclusion in the study." - Anonymous Online Contributor

Unverified Answer

What is the upper limit of participants involved in this experiment?

"This medical trial necessitates the participation of 86 qualified individuals in order to commence. Individuals can partake at either University Cancer & Diagnostic Center located in Houston, Texas or West Cancer Center situated in Germantown, Tennessee." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.