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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Tumor size ≤7 cm, at the longest diameter.
Single lesion per subject.
Timeline
Screening 1 day
Treatment 12 months
Follow Up 12 months
Awards & highlights
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.
Who is the study for?
This trial is for adults over 18 with recurrent skin cancer (cutaneous Squamous Cell Carcinoma) that's not treatable by surgery or standard radiation. Participants must have tried at least one standard treatment, be in fairly good health with a life expectancy of more than a year, and able to undergo CT scans. They should also agree to use effective birth control methods.Check my eligibility
What is being tested?
The study tests DaRT seeds - a type of internal radiation therapy - on up to 86 patients across multiple centers. It aims to see how well the treatment works (measured by tumor response), how long it lasts, its safety profile, and effects on survival rates and quality of life.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks associated with internal radiation therapy like DaRT may include localized skin reactions, discomfort at the implant site, fatigue, and potential damage to nearby healthy tissue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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 without affecting vital organs.
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I can take care of myself but might not be able to do heavy physical work.
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I am willing and able to sign the Informed Consent form.
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My kidney function is within the normal range.
Timeline
Screening ~ 1 day15 visits
Treatment ~ 12 months15 visits
Follow Up ~ 12 months12 visits
Screening ~ 1 day
Treatment ~ 12 months
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Duration of Response
Objective Response Rate
Secondary outcome measures
DaRT-related Adverse Events
Overall Duration of Response (O-DOR)
Overall Survival
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: DaRT seedsExperimental Treatment1 Intervention
DaRT source will be inserted using preplanned radiotherapy parameters and reassessed by volumetric imaging 2-3 weeks after placement and then removed. Objective Response Rate (ORR) will be determined based on confirmed BOR following DaRT insertion.
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Who is running the clinical trial?
Alpha Tau Medical LTD.Lead Sponsor
24 Previous Clinical Trials
734 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are able to have a CT scan.My cancer has spread deeply or to nerves.I have skin cancer that has not been treated and needs surgery or radiation.My cancer is located in the mucosal, vulvar, anal, or penile areas.I have another cancer besides the one being studied, but it's either not growing or doesn't need treatment right now.DaRT seeds cannot be placed in my tumor due to its location near bones or vital organs.You have tattoos or marks that cannot be easily covered up in digital photos.You are currently pregnant or breastfeeding.I have only one cancerous lesion.My tumor is 7 cm or smaller in its largest size.I am willing and able to sign the Informed Consent form.My kidney function is within the normal range.You are allergic to any part of the treatment.I am currently undergoing or have completed radiation therapy.I do not have serious heart conditions like severe heart failure or recent heart attack.I have not received any live vaccines in the last 30 days.My cancer can be fully treated with DaRT seeds without affecting vital organs.My treatment plan for an implant was approved by a team of specialists.I can take care of myself but might not be able to do heavy physical work.I am 18 years old or older.My cancer has not spread to distant organs or lymph nodes.I am currently receiving or have received chemotherapy or biological therapy for cancer.I am currently receiving or have received immunotherapy.My cancer diagnosis was confirmed by a biopsy within the last 6 months, and I haven't received any cancer treatment since then.I am not on long-term immunosuppressive drugs, except for short-term steroids.My tumor is identified as keratoacanthoma type.You are currently taking other experimental drugs besides the one being studied.My cancer cannot be fully treated with DaRT seeds.I am using or willing to use effective birth control methods for 3 months after treatment.My largest tumor is bigger than 7 cm.My skin cancer has returned, treatments didn't work, and surgery or radiation isn't an option for me.You have a medical or mental condition that may make it difficult for you to handle the treatment or follow the study guidelines, as determined by the doctor in charge.
Research Study Groups:
This trial has the following groups:- Group 1: DaRT seeds
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 1 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 12 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 12 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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