Squamous Cell CarcinomaDaRTNCT03015883
Alpha Radiation Emitters Device for the Treatment of Squamous Cell Carcinoma
A study testing Diffusing Alpha Radiation Emitters Therapy (DaRT) in people with Squamous Cell Carcinoma, run by Alpha Tau Medical LTD. at 1 site in Israel.
Trial summary
A unique approach for cancer 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
- Squamous Cell Carcinoma
- What is being tested?
- Diffusing Alpha Radiation Emitters Therapy (DaRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteIsrael
- Study dates
- 22 Feb 2017to 25 Jun 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
- Histopathological confirmation of squamous cell carcinoma.
- Tumor size ≤ 5 centimeters in the longest diameter.
- Age over 18.
- Women of childbearing potential will have evidence of negative pregnancy test.
- Life expectancy of more than 6 months.
- Performance status 2 (ECOG scale) or less.
- Signed informed consent form.
Who cannot join
- Tumor maximal diameter > 5 centimeters.
- Tumor of Keratoacanthoma histology.
- Performance status ≥ 3 (ECOG scale).
- Patients with moribund diseases, autoimmune diseases or vasculitis.
- Patients under immunosuppressive and/or corticosteroid treatment.
- Volunteers that participated in other studies in the past 30 days.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Davidof Cancer Institution at the Rabin Medical Center Israel
Petah Tikva, 49100
About this study
Official title: A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Squamous Cell Carcinoma (First in Man)
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device.
Read the detailed description
This will be a prospective, first in man, controlled study, assessing the safety and efficacy of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds inserted into the tumor.
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 days after DaRT insertion will be assessed.
Safety will be assessed by the incidence, severity and frequency of all Adverse Events (AE).
- Conditions
- Squamous Cell Carcinoma
- Being tested
- Diffusing Alpha Radiation Emitters Therapy (DaRT)
- Keywords
- Squamous Cell Carcinoma, Alpha emitting radiation, Skin Cancer, Carcinoma, Squamous, HNSCC
- Medical subject headings
- Carcinoma, Squamous Cell, Skin Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusing Alpha Radiation Emitters Therapy (DaRT)Radiation
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 |
|---|---|---|
| Diffusing Alpha Radiation Emitters Therapy (DaRT) | Experimental | Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seed Devices Receives: 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 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 posted10 Jan 2017 (estimated)
- Study start22 Feb 2017
- Primary completion1 Jun 2019
- Study completion25 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 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
- Investigators
- Noga Kurman, MD, Principal investigator, Davidof Cancer Institution at the Rabin Medical Center Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015883
- Sponsor's protocol ID
- CTP-SCC-00
- Acronym
- DaRT
- Status last verified
- Jan 2021
- First submitted
- 5 Jan 2017
- Last updated
- 13 Jan 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 13 Jan 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 (First in Man)
- ClinicalTrials.gov ID
- NCT03015883
- Acronym / sponsor ID
- DaRT / CTP-SCC-00
- Conditions
- Squamous Cell Carcinoma
- Keywords
- Squamous Cell Carcinoma, Alpha emitting radiation, Skin Cancer, Carcinoma, Squamous, HNSCC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Alpha Tau Medical LTD.Industry (pharma, biotech, devices)
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 25 Jun 2019 (actual)
- First posted
- 10 Jan 2017 (estimated)
- 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 cancer treatment employing intratumoral diffusing alpha radiation emitter device.
Detailed description
This will be a prospective, first in man, controlled study, assessing the safety and efficacy of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds inserted into the tumor.
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 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
| Arm | Type | Receives |
|---|---|---|
| Diffusing Alpha Radiation Emitters Therapy (DaRT) | Experimental | Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seed Devices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histopathological confirmation of squamous cell carcinoma.
- Tumor size ≤ 5 centimeters in the longest diameter.
- Age over 18.
- Women of childbearing potential will have evidence of negative pregnancy test.
- Life expectancy of more than 6 months.
Key exclusion criteria (6 listed)
- Tumor maximal diameter > 5 centimeters.
- Tumor of Keratoacanthoma histology.
- Performance status ≥ 3 (ECOG scale).
- Patients with moribund diseases, autoimmune diseases or vasculitis.
- Patients under immunosuppressive and/or corticosteroid treatment.
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 |
|---|---|---|
| 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. | Radiation | Diffusing Alpha Radiation Emitters Therapy (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 13 Jan 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.
Noga Kurman, MD principal investigator
Davidof Cancer Institution at the Rabin Medical Center Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diffusing Alpha Radiation Emitters Therapy (DaRT) in people with Squamous Cell Carcinoma, run by Alpha Tau Medical LTD. at 1 site in Israel.
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 6 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 13 Jan 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 Israel. 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 13 Jan 2021.