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Alpha Radiation Emitters Device for the Treatment of Liver Metastases (DaRT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05829291
Recruitment Status : Recruiting
First Posted : April 25, 2023
Last Update Posted : November 8, 2023
Sponsor:
Information provided by (Responsible Party):
Alpha Tau Medical LTD.

Brief Summary:
This is a single center study enrolling up to 10 patients. The primary objective is to Evaluate the feasibility and safety of the DaRT for the treatment of Liver Metastases. The secondary objective is to evaluate the pathological response of liver metastases according to the Modified tumor regression grade[1] and to evaluate the radiological response of liver metastases using the RECIST criteria.

Condition or disease Intervention/treatment Phase
Liver Metastases Device: Diffusing Alpha Radiation Emitters Therapy (DaRT) Not Applicable

Detailed Description:

This study is a Prospective, Open label, one arm, single center study to evaluate the feasibility and safety of Diffusing Alpha Radiation Emitters for the treatment of Liver Metastases .

The "Diffusing Alpha-emitter Radiation Therapy (DaRT)", based on the interstitial intratumoral placement of an encapsulated Radium-224 source (3.7 days half-life), is described in this study. These sources release short-lived alpha-emitting atoms into the tumor microenvironment by recoil. DaRT seeds will be inserted into recurrent Squamous Cell Carcinoma (SCC) tumors and will be removed following 14-21 days.

The Primary endpoint of the study is : 1) Feasibility assessments of the ability to achieve full volume coverage of liver metastases volume.

2) Safety of the Alpha DaRT Seeds as therapy for liver metastases , Safety will be assessed and recorded according to CTCAE V5.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Liver Metastases
Actual Study Start Date : October 1, 2023
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : February 2026

Arm Intervention/treatment
Experimental: DaRT Seeds
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
Device: Diffusing Alpha Radiation Emitters Therapy (DaRT)
An intratumoral insertion of radioactive sources [Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)]. The seeds release by recoil into the tumor short-lived alpha-emitting atoms




Primary Outcome Measures :
  1. Feasibility - DaRT seed placement [ Time Frame: From first operation - DaRT insertion up to 24 months ]
    Assessment of successful placement of the Alpha DaRT Seeds into liver metastases during a 2-stage hepatectomy via imaging

  2. Safety - Adverse events [ Time Frame: Up to 24 months ]
    Assess the frequency and severity of acute adverse events related to DaRT. Adverse events will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0.


Secondary Outcome Measures :
  1. To evaluate the pathological response of liver metastases according to the Modified tumor regression grade 1 [ Time Frame: 7-9 Weeks post DaRT insertion ]
    Pathological response to Alpha DaRT Seeds in covered areas after surgery

  2. To evaluate the radiological response of liver metastases using the RECIST criteria . [ Time Frame: 6-8 weeks post DaRT insertion ]
    Radiological response to Alpha DaRT seeds implantation after the Alpha DaRT Seeds insertion procedure and prior to the second stage



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Referred for a two staged hepatectomy following a multidisciplinary team discussion, to resect liver metastases of colorectal cancer
  2. Targetable lesion(s) must be technically amenable for complete coverage (including margins) by the Alpha DaRT Seeds / Target(s) must be reachable for implantation
  3. Liver lesions are visible and measurable by CT according to RECIST v 1.1
  4. Age ≥ 18 years old
  5. ECOG Performance Status Scale ≤ 2
  6. Subjects' life expectancy is at least 12 weeks
  7. The following laboratory parameters

    • WBC ≥ 3500/µl, granulocyte ≥ 1500/µl
    • Hemoglobin > 85 g/L
    • Total bilirubin < 51.3 umol/L
    • Platelet count >75 X 109 /L or > 50% Prothrombin activity
    • Amylase and lipase < 1.5 X the upper limit of normal
    • AST and ALT ≤ 5 X ULN
    • Prothrombin time (PT) international normalized ratio (INR) < 2.3 or PT < 6 seconds above control. Patients who are being therapeutically anticoagulated with an agent such as Coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists
  8. Subjects are willing and able to sign an informed consent form
  9. Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test within seven days before the Ra-224 implantation
  10. Subjects must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy

Exclusion Criteria:

  1. Concurrent cancer that is distinct in primary site or histology from colorectal cancer. Except cervical carcinoma in situ, prostate cancer with good prognosis, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated 3 years prior to entry is permitted.
  2. Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids
  3. Contraindication to angiography:

    • Any bleeding diathesis or coagulopathy that is not correctable by usual therapy or hemostatic agent
    • Severe peripheral vascular disease precluding catheterization
    • History of severe allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically
  4. Known hypersensitivity to any of the components of the treatment.
  5. 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.
  6. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
  7. Brain metastases
  8. Active clinically serious infections
  9. Major surgery within 4 weeks of start of the study therapy
  10. Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy 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.
  11. Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
  12. High probability of protocol non-compliance (in opinion of investigator)
  13. Pregnant or breastfeeding women
  14. 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 DaRT

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05829291


Contacts
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Contact: Liron Dimnik +972237377000 LironD@alphatau.com

Locations
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Canada, Quebec
e McGill University Health Centre (MUHC) Recruiting
Montréal, Quebec, Canada, H4A 3T2
Contact: Peter Metrakos, MD         
Contact: Anthoula Lazaris       anthoula.lazaris@mail.mcgill.ca   
Sponsors and Collaborators
Alpha Tau Medical LTD.
Investigators
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Principal Investigator: Peter Metrakos, MD McGill University Health Centre/Research Institute of the McGill University Health Centre
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Responsible Party: Alpha Tau Medical LTD.
ClinicalTrials.gov Identifier: NCT05829291    
Other Study ID Numbers: CTP-LIV-00
First Posted: April 25, 2023    Key Record Dates
Last Update Posted: November 8, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alpha Tau Medical LTD.:
Alpha radiation
Alpha emitting radiation
Liver Metastases
Brachytherapy
Additional relevant MeSH terms:
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Neoplasm Metastasis
Liver Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases