Health TrialsbyHealthPanel

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

ConditionLiver Metastases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlpha Tau Medical LTD.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids

Any bleeding diathesis or coagulopathy that is not correctable by usual therapy or hemostatic agent

Severe peripheral vascular disease precluding catheterization

Trial design

Design model

Single group

Treatments tested in this trial

  • 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".

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: DaRT SeedsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility - DaRT seed placement

Assessment of successful placement of the Alpha DaRT Seeds into liver metastases during a 2-stage hepatectomy via imaging

Time frame
From first operation - DaRT insertion up to 24 months
2

Safety - Adverse events

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.

Time frame
Up to 24 months

Secondary outcomes

1

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

Pathological response to Alpha DaRT Seeds in covered areas after surgery

Time frame
7-9 Weeks post DaRT insertion
2

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

Radiological response to Alpha DaRT seeds implantation after the Alpha DaRT Seeds insertion procedure and prior to the second stage

Time frame
6-8 weeks post DaRT insertion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alpha Tau Medical LTD.

Lead sponsor

Source ClinicalTrials.gov
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