Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05829291

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

Led by Alpha Tau Medical LTD. · Updated on 2024-05-10

10

Participants Needed

1

Research Sites

122 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Referred for two staged hepatectomy to remove colorectal cancer liver metastases
  • Liver lesions must be targetable and reachable for complete coverage by Alpha DaRT Seeds
  • Liver lesions visible and measurable by CT using RECIST v 1.1
  • Age 18 years or older
  • ECOG Performance Status of 2 or less
  • Life expectancy at least 12 weeks
  • Laboratory values within specified limits: WBC ≥ 3500/µl, granulocytes ≥ 1500/µl, hemoglobin > 85 g/L, total bilirubin < 51.3 µmol/L, platelet count > 75 x 10^9/L or > 50% prothrombin activity, amylase and lipase < 1.5 times upper limit of normal, AST and ALT ≤ 5 times upper limit of normal, PT INR < 2.3 or PT < 6 seconds above control
  • Able and willing to sign informed consent
  • Women of childbearing potential must have a negative pregnancy test within 7 days before implantation
  • Agree to use adequate contraception during the study and for 3 months after treatment
Not Eligible

You will not qualify if you...

  • Having another concurrent cancer different from colorectal cancer except certain treated or low-risk cancers
  • Receiving systemic immunosuppressive therapy except brief corticosteroid use
  • Contraindications to angiography including uncorrectable bleeding disorders, severe peripheral vascular disease, or severe allergies to contrast agents or sedatives
  • Known allergy to treatment components
  • Significant cardiovascular disease such as severe heart failure, uncontrolled coronary artery disease, recent heart attack
  • Significant gastrointestinal bleeding within 30 days before study
  • Presence of brain metastases
  • Active serious infections
  • Major surgery within 4 weeks before study treatment
  • Uncontrolled illnesses including psychiatric or substance abuse disorders interfering with study compliance
  • Any unstable condition risking patient safety or study compliance
  • High risk of protocol non-compliance as judged by investigator
  • Pregnant or breastfeeding women
  • Participation in another interventional study within 30 days that may affect study outcomes

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
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Trial Site Locations

Total: 1 location

1

e McGill University Health Centre (MUHC)

Montreal, Quebec, Canada, H4A 3T2

Actively Recruiting

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Research Team

L

Liron Dimnik

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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