Testing Diffusing Alpha Radiation Emitters for liver metastases
Official title: Alpha Radiation Emitters Device (DaRT) for the Treatment of Liver Metastases
A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Liver Metastases
- 1 group
- One site, in Montreal
- Recruiting
Interventions
- Medical device
Diffusing Alpha Radiation Emitters Therapy (DaRT)
Alpha DaRT Applicators (the Alpha Needle Applicator, the Alpha Flex Applicator, and the Alpha Plant Applicator) and radioactive sources named Alpha DaRT Seeds - Ra-224 coated onto stainless steel tubes inserted into the tumor. Collectively, the Alpha DaRT Applicators and Seeds are referred to as the "Alpha DaRT Device".
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
e McGill University Health Centre (MUHC)
Montreal, Quebec
Eligibility Criteria
See who this study is looking for34 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age ≥ 18 years old
- +Referred for a two staged hepatectomy following a multidisciplinary team discussion, to resect liver metastases of colorectal cancer
- +Targetable lesion(s) must be technically amenable for complete coverage (including margins) by the Alpha DaRT Seeds / Target(s) must be reachable for implantation
- +Liver lesions are visible and measurable by CT according to RECIST v 1.1
- +ECOG Performance Status Scale ≤ 2
- +Subjects' life expectancy is at least 12 weeks
- +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 controlControl groupThe group a new treatment is measured against.Read more →. 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
- +Subjects are willing and able to sign an informed consent formInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test within seven days before the Ra-224 implantation
- +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
- −History of severe allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically
- −Known hypersensitivity to any of the components of the treatment.
- −Brain metastases
- −Concurrent cancer that is distinct in primary siteTrial siteA hospital or clinic where a study is actually run.Read more → 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.
- −Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids
- −Contraindication to angiography:
- −Any bleeding diathesis or coagulopathy that is not correctable by usual therapy or hemostatic agent
- −Severe peripheral vascular disease precluding catheterization
- −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 clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- −Active clinically serious infections
- −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 endpointsEndpointThe specific thing a study measures to answer its question.Read more →.
- −Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
- −High probability of protocolProtocolThe detailed plan a study must follow.Read more → non-compliance (in opinion of investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →)
- −Volunteers participating in another interventional studyInterventional studyA study where participants are given something to see what happens.Read more → in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT
- −Pregnant or breastfeeding women
- −Major surgery within 4 weeks of start of the study therapy
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study is in one group and receives Diffusing Alpha Radiation Emitters Therapy (DaRT).
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 10 people.
The study is currently expected to finish around July 2027.
The main measurement is taken over: From first operation - DaRT insertion up to 24 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Feasibility - DaRT seed placement — measured over From first operation - DaRT insertion up to 24 months.
Safety - Adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → — measured over Up to 24 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05829291 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Diffusing Alpha Radiation Emitters Therapy (DaRT)Device
Alpha DaRT Applicators (the Alpha Needle Applicator, the Alpha Flex Applicator, and the Alpha Plant Applicator) and radioactive sources named Alpha DaRT Seeds - Ra-224 coated onto stainless steel tubes inserted into the tumor. Collectively, the Alpha DaRT Applicators and Seeds are referred to as the "Alpha DaRT Device".
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From first operation - DaRT insertion up to 24 months.
The study as a whole is currently expected to finish around 2027-07.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 10 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Montreal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.