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New treatment option for Liver Metastases
Official title Alpha Radiation Emitters Device (DaRT) for the Treatment of Liver Metastases
ClinicalTrials.gov ID: NCT05829291
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Liver lesions are visible and measurable by CT according to RECIST v 1.1
- Age ≥ 18 years old
- ECOG Performance Status Scale ≤ 2
You likely can't join if
- Concurrent cancer that is distinct in primary site or histology from colorectal cancer. Except cervical carcinoma in situ, prostate cancer with good...
- 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
- History of severe allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically
See the full eligibility criteria
- 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
- Age ≥ 18 years old
- ECOG Performance Status Scale ≤ 2
- people' 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 control. Patients who are being therapeutically anticoagulated with an agent such as Coumadin or heparin will be allowed to...
- people are willing and able to sign an informed consent form
- Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test within seven days before the Ra-224 implantation
- people 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
- 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...
- 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
- 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.
- 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...
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- Brain metastases
- Active clinically serious infections
- Major surgery within 4 weeks of start of the study therapy
- 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...
- Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
- High probability of protocol non-compliance (in opinion of investigator)
- Pregnant or breastfeeding women
- Volunteers participating in another treatment study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT \-
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.