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Radiopharmaceutical

DaRT for Liver Metastases

N/A

Recruiting

Led By Peter Metrakos, MD

Research Sponsored by Alpha Tau Medical LTD.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study Summary

This trial is testing a new treatment for liver metastases to see if it is safe and effective. #medicine #health #clinicaltrial

Who is the study for?

This trial is for adults over 18 with liver metastases from colorectal cancer, who are planned for a two-stage hepatectomy. Participants must have adequate liver function, visible and measurable lesions by CT scan, an ECOG performance status of ≤2 (meaning they can care for themselves), and a life expectancy of at least 12 weeks.Check my eligibility

What is being tested?

The study is testing the safety and feasibility of DaRT—Diffusing Alpha Radiation Emitters Therapy—for treating liver metastases. It will also assess how well the tumors respond to this treatment both pathologically, using tumor regression grading, and radiologically with RECIST criteria.See study design

What are the potential side effects?

While specific side effects aren't listed here, treatments like DaRT could potentially cause localized damage to healthy liver tissue or nearby organs due to radiation exposure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility - DaRT seed placement

Safety - Adverse events

Secondary outcome measures

To evaluate the pathological response of liver metastases according to the Modified tumor regression grade 1

To evaluate the radiological response of liver metastases using the RECIST criteria .

Trial Design

1Treatment groups

Experimental Treatment

Group I: DaRT SeedsExperimental Treatment1 Intervention

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Diffusing Alpha Radiation Emitters Therapy (DaRT)

2017

N/A

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Alpha Tau Medical LTD.Lead Sponsor

24 Previous Clinical Trials

810 Total Patients Enrolled

Peter Metrakos, MDPrincipal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre

1 Previous Clinical Trials

5 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are presently involved in this experimentation?

"That is accurate. According to clinicaltrials.gov, this medical investigation which was initially debuted on October 1st 2023, is in the midst of actively recruiting participants. Specifically, 10 people are needed from a single research centre."

Answered by AI

Is this experiment currently taking on new participants?

"According to clinicaltrials.gov, the trial is in active recruitment and was initially posted on October 1st 2023 with it's last update occuring November 6th 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Alpha Radiation Emitters Device for the Treatment of Liver Metastases (DaRT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05829291.