Carcinoma of the VulvaNCT06202339
Alpha Radiation Emitters Device for the Treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva (DaRT).
A study testing DaRT seeds in people with Carcinoma of the Vulva and Recurrent Carcinoma of the Vulva, run by Alpha Tau Medical LTD..
Trial summary
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Carcinoma of the Vulva, Recurrent Carcinoma of the Vulva
- What is being tested?
- DaRT seeds
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed newly diagnosed or recurrent (local) vulva SCC with or without distant metastases within 12 months
- Tumor size ≤ 7 centimeters in the longest diameter.
- Targeted lesion must be technically amenable for complete coverage (including margins) by the Alpha DaRT sources.
- Measurable target according to RECIST v1.1
- Interstitial implant indication validated by multidisciplinary team.
- ECOG Performance Status ≤3.
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- Life expectancy ≥6 months.
- Women Age ≥18
- Willing and have the ability to provide signed Informed Consent.
- Willing to use an acceptable contraceptive method to prevent pregnancy for 3 months after RT.
- Blood tests values:
- Leucocytes ≥3000mm3,
- Absolute neutrophil count ≥1500mm3,
- Platelets ≥100,000 mm3,
- Total bilirubin ≤ 1.5xULN,
- AST, SGOT, SGPT ≤2.5xULN, If Alkaline Phosphatase ≤ 4xULN, then transaminases are normal.
- Creatinine ≤ 2.0xULN.
- INR or Prothrombin time ≤1.5xULN.
Who cannot join
- Concomitant chemotherapy or immunotherapy within the past 4 weeks
- Fit for surgical exploration unless the patient refuses surgery
- Known hypersensitivity to any of the components of the treatment.
- Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
- Longest tumor diameter >7 cm.
- Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.
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- Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy (not including cholangitis) or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of Alpha DaRT.
- Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of Alpha DaRT.
- High probability of protocol non-compliance (in opinion of investigator).
- Breastfeeding women or women of childbearing potential unwilling or unable to use an acceptable contraceptive method to prevent pregnancy for 3 months after RT.
- Subjects not willing to sign an informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva.
Read the detailed description
This is an prospective Open label, single arm, multi center, interventional study treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva .The study objectives are to collect data on the Feasibility and Safety of DaRT among patients who do not fit the entry of existing investigational trials.
The primary endpoint of the study is to evaluate the feasibility and safety of the Alpha DaRT sources for the treatment of vulva SCC. Feasibility will be determined according to the rate of successful placement of Alpha DaRT . Safety will be determined according to the overall incidence of device related AEs and SAE's graded according to CTCAE v5.0 criteria.
The Secondary endpoint of the study will be to evaluate efficacy, as determined by local control evaluation according to RECIST v1.1
- Being tested
- DaRT seeds
- Keywords
- Cancer, Alpha emitting radiation, Brachytherapy, DaRT
- Medical subject headings
- Vulvar Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaRT seedsDevice
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 |
|---|---|---|
| DaRT Seeds | Experimental | Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds Receives: Device: DaRT seeds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - DaRT seed placement
Feasibility will be determined according to the rate of successful placement of Alpha DaRT
Measured: immediately following the insertion procedure
Safety - Adverse events
Safety will be determined according to the overall incidence of device related AEs and SAE's graded according to CTCAE v5.0 criteria.
Measured: From day 0
Secondary outcomes (1)
Efficacy -Alpha DaRT seeds
The study's secondary objective will be to evaluate efficacy, as determined by local control evaluation according to RECIST v1.1
Measured: 1, 3, and 6 months post DaRT insertion].
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study startApr 2024 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma of the VulvaStudies 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
- 10 participants (estimated)
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
- NCT06202339
- Sponsor's protocol ID
- CTP-VUL-01
- Status last verified
- Dec 2023
- First submitted
- 31 Dec 2023
- Last updated
- 31 Jan 2024
- Results posted
- 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 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva
- ClinicalTrials.gov ID
- NCT06202339
- Acronym / sponsor ID
- CTP-VUL-01
- Keywords
- Cancer, Alpha emitting radiation, Brachytherapy, DaRT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Alpha Tau Medical LTD.Industry (pharma, biotech, devices)
- Study start
- Apr 2024 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Jan 2024 (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 cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva.
Detailed description
This is an prospective Open label, single arm, multi center, interventional study treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva .The study objectives are to collect data on the Feasibility and Safety of DaRT among patients who do not fit the entry of existing investigational trials.
The primary endpoint of the study is to evaluate the feasibility and safety of the Alpha DaRT sources for the treatment of vulva SCC. Feasibility will be determined according to the rate of successful placement of Alpha DaRT . Safety will be determined according to the overall incidence of device related AEs and SAE's graded according to CTCAE v5.0 criteria.
The Secondary endpoint of the study will be to evaluate efficacy, as determined by local control evaluation according to RECIST v1.1
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DaRT Seeds | Experimental | Device: DaRT seedsIntratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histologically confirmed newly diagnosed or recurrent (local) vulva SCC with or without distant metastases within 12 months
- Tumor size ≤ 7 centimeters in the longest diameter.
- Targeted lesion must be technically amenable for complete coverage (including margins) by the Alpha DaRT sources.
- Measurable target according to RECIST v1.1
- Interstitial implant indication validated by multidisciplinary team.
Key exclusion criteria (13 listed)
- Concomitant chemotherapy or immunotherapy within the past 4 weeks
- Fit for surgical exploration unless the patient refuses surgery
- Known hypersensitivity to any of the components of the treatment.
- Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
- Longest tumor diameter >7 cm.
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 |
|---|---|---|
| DaRT seedsAn 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 | DaRT Seeds |
Primary outcome
Feasibility - DaRT seed placement
Time frame: immediately following the insertion procedure
Feasibility will be determined according to the rate of successful placement of Alpha DaRT
Safety - Adverse events
Time frame: From day 0
Safety will be determined according to the overall incidence of device related AEs and SAE's graded according to CTCAE v5.0 criteria.
1 secondary outcome
Efficacy -Alpha DaRT seeds
Time frame: 1, 3, and 6 months post DaRT insertion].
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing DaRT seeds in people with Carcinoma of the Vulva and Recurrent Carcinoma of the Vulva, run by Alpha Tau Medical LTD..
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 18 inclusion and 13 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: opening soon, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liron Dimnik (+972542688602, LironD@alphatau.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - DaRT seed placement (time frame: immediately following the insertion procedure). 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 31 Jan 2024.