Skin Squamous Cell CarcinomaNCT03353077
Alpha Radiation Emitters Device for the Treatment of Squamous Cell Carcinoma (DaRT)
A study testing Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) in people with Skin Squamous Cell Carcinoma, run by Alpha Tau Medical LTD. at 1 site in Italy.
Trial summary
A unique approach for Skin Squamous Cell Carcinoma (SCC) treatment employing intratumoral diffusing alpha radiation emitter device Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Squamous Cell Carcinoma
- What is being tested?
- Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteItaly
- Study dates
- 21 Nov 2017to 14 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with histopathological confirmation of skin squamous cell carcinoma before surgical removal of the tumor.
- Subjects with a tumor size ≤ 5 centimeters in the longest diameter (lesions without nodal spread).
- Subjects' age is over 18 years old.
- Subjects' ECOG Performance Status Scale is ≤ 2.
- Subjects' life expectancy is more than 6 months.
- Female subjects of childbearing age will have evidence of negative pregnancy test.
- Subjects are willing to sign an informed consent form.
Who cannot join
- Subject has a tumor with a maximal diameter > 5 centimeters.
- Subject has an ulcerative lesion.
- Subject has a tumor of Keratoacanthoma histology.
- Subjects' ECOG Performance Status Scale is ≥ 3.
- Patients with moribund diseases, e.g., autoimmune diseases, vasculitis, etc.
- Patients under immunosuppressive and/or corticosteroid treatment.
Show all 9Show fewer
- Volunteers that participated in other studies in the past 30 days that might affect the evaluation of response or toxicity of DaRT.
- Pregnant women.
- Subjects not willing to sign an informed consent form.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
Meldola
About this study
Official title: A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Squamous Cell Carcinoma
A unique approach for Skin Squamous Cell Carcinoma (SCC) treatment employing intratumoral diffusing alpha radiation emitter device
Read the detailed description
This will be a prospective study, assessing the safety and effectiveness of intratumoral alpha radiation mediated treatment with Alpha DaRT seeds for the treatment of Skin Squamous Cell Carcinoma (SCC) tumors.
Treatment will be delivered through radioactive sources (Alpha DaRT seeds) inserted into the tumors in the skin. This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients.
Lesions with histopathological diagnosis of squamous cell carcinoma will be studied.
Reduction in tumor size 30-45 days after DaRT insertion will be assessed. Safety will be assessed by the incidence, severity and frequency of all Adverse Events (AE).
- Conditions
- Skin Squamous Cell Carcinoma
- Being tested
- Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
- Keywords
- Skin SCC, Skin Carcinoma, Squamous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)Device
Also called DaRT
An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.
| Study group | Role | What they receive |
|---|---|---|
| Alpha DaRT | Experimental | Alpha DaRT Seeds, Diffusing alpha-emitters Radiation Therapy. Receives: Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
The incidence, severity and frequency of all Adverse Events
Measured: 30-45 days post seed insertion
Reduction in Tumor size
The reduction in tumor size 30-45 days after DaRT insertion
Measured: 30-45 days post seed insertion
Secondary outcomes (1)
Percent of NecroticTissue
Percent of necrotic tissue in the tumor 30-45 days after DaRT insertion
Measured: 30-45 days post seed insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start21 Nov 2017
- Primary completion14 Jul 2019
- Study completion14 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Alpha Tau Medical LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alpha Tau Medical LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353077
- Sponsor's protocol ID
- CTP-SCC-000
- Status last verified
- Mar 2021
- First submitted
- 15 Nov 2017
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT03353077
- Acronym / sponsor ID
- CTP-SCC-000
- Conditions
- Skin Squamous Cell Carcinoma
- Keywords
- Skin SCC, Skin Carcinoma, Squamous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Alpha Tau Medical LTD.Industry (pharma, biotech, devices)
- Study start
- 21 Nov 2017 (actual)
- Primary completion
- 14 Jul 2019 (actual)
- Study completion
- 14 Jul 2019 (actual)
- First posted
- 27 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A unique approach for Skin Squamous Cell Carcinoma (SCC) treatment employing intratumoral diffusing alpha radiation emitter device
Detailed description
This will be a prospective study, assessing the safety and effectiveness of intratumoral alpha radiation mediated treatment with Alpha DaRT seeds for the treatment of Skin Squamous Cell Carcinoma (SCC) tumors.
Treatment will be delivered through radioactive sources (Alpha DaRT seeds) inserted into the tumors in the skin. This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients.
Lesions with histopathological diagnosis of squamous cell carcinoma will be studied.
Reduction in tumor size 30-45 days after DaRT insertion will be assessed. Safety will be assessed by the incidence, severity and frequency of all Adverse Events (AE).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Alpha DaRT | Experimental | Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)Alpha DaRT Seeds, Diffusing alpha-emitters Radiation Therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects with histopathological confirmation of skin squamous cell carcinoma before surgical removal of the tumor.
- Subjects with a tumor size ≤ 5 centimeters in the longest diameter (lesions without nodal spread).
- Subjects' age is over 18 years old.
- Subjects' ECOG Performance Status Scale is ≤ 2.
- Subjects' life expectancy is more than 6 months.
Key exclusion criteria (9 listed)
- Subject has a tumor with a maximal diameter > 5 centimeters.
- Subject has an ulcerative lesion.
- Subject has a tumor of Keratoacanthoma histology.
- Subjects' ECOG Performance Status Scale is ≥ 3.
- Patients with moribund diseases, e.g., autoimmune diseases, vasculitis, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)Also: DaRTAn intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms. | Device | Alpha DaRT |
Primary outcome
Adverse Events
Time frame: 30-45 days post seed insertion
The incidence, severity and frequency of all Adverse Events
Reduction in Tumor size
Time frame: 30-45 days post seed insertion
The reduction in tumor size 30-45 days after DaRT insertion
1 secondary outcome
Percent of NecroticTissue
Time frame: 30-45 days post seed insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) in people with Skin Squamous Cell Carcinoma, run by Alpha Tau Medical LTD. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 30-45 days post seed insertion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.