Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03015883
Other study ID # CTP-SCC-00
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 22, 2017
Est. completion date June 25, 2019

Study information

Verified date January 2021
Source Alpha Tau Medical LTD.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device.


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).


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date June 25, 2019
Est. primary completion date June 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Histopathological confirmation of squamous cell carcinoma. 2. Tumor size = 5 centimeters in the longest diameter. 3. Age over 18. 4. Women of childbearing potential will have evidence of negative pregnancy test. 5. Life expectancy of more than 6 months. 6. Performance status 2 (ECOG scale) or less. 7. Signed informed consent form. Exclusion Criteria: 1. Tumor maximal diameter > 5 centimeters. 2. Tumor of Keratoacanthoma histology. 3. Performance status = 3 (ECOG scale). 4. Patients with moribund diseases, autoimmune diseases or vasculitis. 5. Patients under immunosuppressive and/or corticosteroid treatment. 6. Volunteers that participated in other studies in the past 30 days.

Study Design


Intervention

Radiation:
Diffusing Alpha Radiation Emitters Therapy (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.

Locations

Country Name City State
Israel Davidof Cancer Institution at the Rabin Medical Center Israel Petah Tiqva

Sponsors (1)

Lead Sponsor Collaborator
Alpha Tau Medical LTD.

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse Events The incidence, severity and frequency of all Adverse Events 30-45 days post seed insertion
Primary Reduction in Tumor size The reduction in tumor size 30-45 days after DaRT insertion 30-45 days post seed insertion
Secondary Percent of NecroticTissue Percent of necrotic tissue in the tumor 30 days after DaRT insertion 30-45 days post seed insertion
See also
  Status Clinical Trial Phase
Terminated NCT02213133 - Selinexor Treatment of Advanced Relapsed/Refractory Squamous Cell Carcinomas Phase 2
Not yet recruiting NCT04533321 - A Biomarker-implemented Clinical Study Evaluating Mutations in MET and TP53 in a Population of Treatment-refractory Squamous Cell Carcinoma Phase 2
Terminated NCT02890368 - Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides Phase 1
Active, not recruiting NCT01232374 - Nimotuzumab in Combination With Chemoradiation for Local Advanced Esophageal Squamous Cell Carcinoma Phase 2
Completed NCT01208883 - A Feasibility Study On Continuous Adaptive [18f]Fdg-Pet-Guided Radiotherapy For Head and Neck Cancer Phase 1
Withdrawn NCT01148082 - School Response to Families Who Have Children With Cancer N/A
Completed NCT01089803 - Observational Study of Swallowing Function After Treatment of Advanced Laryngeal Cancer N/A
Terminated NCT00707655 - Zalutumumab in Combination With Radiotherapy in Head and Neck Cancer Patients Ineligible for Platinum Based Chemotherapy Phase 1/Phase 2
Completed NCT01127737 - Warning Signs of Squamous Cell Carcinoma and Prevention of SCC by at Risk Organ Transplant Recipients N/A
Completed NCT00793169 - Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery
Completed NCT00586040 - Photochemical Tissue Bonding Phase 2
Completed NCT00409565 - A Phase II Trial of Cetuximab and Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer Phase 2
Completed NCT00176267 - Paclitaxel, Carboplatin And Low Dose Radiation As Induction Therapy In Locally Advanced Head And Neck Cancer Phase 2
Terminated NCT04685798 - Optimized Diffusion-Weighted Imaging for the Evaluation of Post-Treatment Squamous Cell Carcinoma in the Neck: Comparative Study With FDG PET/CT N/A
Recruiting NCT04370587 - A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT04475952 - Early Diagnosis of Upper Digestive Tract Disease
Recruiting NCT04435938 - A Study of SBRT for Squamous Cell Carcinoma of the Head and Neck Phase 2
Not yet recruiting NCT05852665 - Buccal Cancer Resection Ultrasound Guided N/A
Recruiting NCT05048459 - Comparing Two Surveillance Approaches for People Who Have Received Treatment for HPV-associated Head and Neck Cancer and Show No Signs of Disease N/A
Suspended NCT03952585 - De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer Phase 2/Phase 3