Alpha Radiation Emitters Device for the Treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva (DaRT).

NCT06202339 | Not Yet Recruiting

• 1 other identifier: CTP-VUL-01
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Carcinoma of the Vulva; Recurrent Carcinoma of the Vulva

Keywords

Cancer; Alpha emitting radiation; Brachytherapy; DaRT

Outcome Measures

Primary Outcomes (2)

• Feasibility - DaRT seed placement

  Feasibility will be determined according to the rate of successful placement of Alpha DaRT

  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.

  From day 0

Secondary Outcomes (1)

• Efficacy -Alpha DaRT seeds

  1, 3, and 6 months post DaRT insertion].

Study Arms (1)

DaRT Seeds

EXPERIMENTAL

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

Device: DaRT seeds

Interventions

DaRT seeds DEVICE

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

DaRT Seeds

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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,

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Alpha Tau Medical LTD.: lead

MeSH Terms

Conditions

Vulvar Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Liron Dimnik

CONTACT

+972542688602; LironD@alphatau.com

Aviya Hoida

CONTACT

+972547869466; aviyah@alphatau.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2023
• First Posted: January 11, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 31, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share