Alpha Radiation Emitters for Pancreatic Cancer

Recruiting at 17 trial locations

Overseen By Liron Dimnik

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alpha Tau Medical LTD.

Must be taking: mFOLFIRINOX

Must not be taking: Immunosuppressants

Disqualifiers: Cardiovascular disease, Uncontrolled illnesses, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 2 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new cancer treatment called Alpha DaRT (Diffusing Alpha Radiation Emitters Therapy), which uses targeted radiation to treat pancreatic cancer. The researchers aim to assess the safety and effectiveness of this treatment when combined with chemotherapy, focusing on patient survival, pain control, and the possibility of surgery. Suitable participants include those with newly diagnosed, advanced pancreatic cancer that remains untreated, except for a few cycles of a specific chemotherapy regimen. As an unphased trial, this study allows patients to contribute to groundbreaking research in cancer treatment.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, it mentions that patients undergoing systemic immunosuppressive therapy are excluded, except for brief use of corticosteroids. It's best to discuss your specific medications with the trial team.

What prior data suggests that this device is safe for pancreatic cancer treatment?

Research has shown that Diffusing Alpha Radiation Emitters Therapy (DaRT) holds promise for safety. In a study on inoperable pancreatic cancer, DaRT proved both feasible and safe. Patients did not experience severe side effects that would prevent treatment continuation. Another study confirmed DaRT's safety and its potential to control tumors, indicating good patient tolerance. While these results are encouraging, they come from early studies, and further research is needed to confirm its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for pancreatic cancer?

Researchers are excited about Diffusing Alpha Radiation Emitters Therapy (DaRT) because it introduces a novel approach to treating pancreatic cancer by using alpha radiation to target cancer cells directly. Unlike traditional chemotherapy, which attacks rapidly dividing cells throughout the body and often causes significant side effects, DaRT delivers localized radiation, minimizing damage to healthy tissue. This targeted approach has the potential to improve outcomes by attacking the tumor more precisely and reducing overall side effects, making the treatment process more tolerable for patients.

What evidence suggests that this trial's treatments could be effective for pancreatic cancer?

Research has shown that Alpha DaRT, a treatment using a special type of radiation, may help treat pancreatic cancer. This therapy delivers strong radiation directly to solid tumors, potentially controlling their growth. In this trial, patients with locally advanced or metastatic pancreatic adenocarcinoma will receive mFOLFIRINOX treatment and undergo DaRT placement. Early findings indicate that patients who received Alpha DaRT experienced safe and manageable outcomes when guided by endoscopic ultrasound. Initial data from treatments in the U.S. demonstrated success in controlling tumors. While more research is needed, these results offer hope for Alpha DaRT's potential in fighting pancreatic cancer. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with newly diagnosed, inoperable locally advanced or metastatic pancreatic adenocarcinoma. Participants must have started chemotherapy with mFOLFIRINOX, have a measurable lesion that's ≤5 cm and can be implanted with Alpha DaRT sources. They should be relatively fit (ECOG 0-2), expected to live more than 6 months, and meet certain blood cell count criteria.

Inclusion Criteria

My cancer can be measured using standard imaging techniques.

My team of doctors has approved me for a specific type of radiation therapy.

My white blood cell count is healthy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mFOLFIRINOX treatment and undergo DaRT placement during the first 4 cycles

Approximately 2 months

Multiple visits for chemotherapy cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Long-term follow-up

Participants are monitored for long-term safety and survival outcomes

Up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Diffusing Alpha Radiation Emitters Therapy (DaRT)

Trial Overview The study tests the safety and effectiveness of Alpha Radiation Emitters Therapy (DaRT) combined with chemotherapy in treating pancreatic cancer. It aims to see how well it works by looking at survival rates, pain control, and whether patients become eligible for surgery after treatment.

How Is the Trial Designed?

Group I: Patients with metastatic pancreatic adenocarcinoma Experimental Treatment 1 Intervention

Patients will begin mFOLFIRINOX treatment and will undergo DaRT placement during the first 4 cycles. Follow-up will continue up to 6 months after enrollment.

Group II: Patients with locally advanced pancreatic adenocarcinoma Experimental Treatment 1 Intervention

Patients will begin mFOLFIRINOX treatment and will undergo DaRT placement during the first 4 cycles. Follow-up will continue up to 6 months after enrollment.

Who Is Running the Clinical Trial?

Alpha Tau Medical LTD.

Lead Sponsor

Trials

28

Recruited

920+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06698458

Study Details | NCT06698458 | Alpha Radiation Emitters ... This study will be a prospective, interventional, open label, two cohort, multiple center study to assess the efficacy of Alpha DaRT in combination with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11469937/

Feasibility and safety of endoscopic ultrasound-guided ... Feasibility and safety of endoscopic ultrasound-guided diffusing alpha emitter radiation therapy for advanced pancreatic cancer: Preliminary data

3. alphatau.com alphatau.com/single-post/alpha-tau-successfully-treats-first-patient-in-its-u-s-multi-center-pancreatic-cancer-clinical-tria

Alpha Tau Successfully Treats First Patient in its U.S. Multi ... Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.4_suppl.741

Interim analysis of feasibility, safety, and tumor control in ... Background: This study aims to report the initial feasibility, safety, and tumor response of delivering Diffusing Alpha-Emitter Radiation ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04002479

Study Details | NCT04002479 | Alpha Radiation Emitters ... The study is designed to evaluate the feasibility, safety and preliminary efficacy of intratumoral alpha radiation mediated treatment with Alpha DaRT seeds for ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39398444/

Feasibility and safety of endoscopic ultrasound-guided ... Preliminary results from this first-in-human trial indicate that EUS-guided Alpha DaRT treatment for unresectable pancreatic cancer is feasible and safe.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05657743

A Feasibility and Safety Study of Intratumoral Diffusing ... The study is designed to evaluate the feasibility and safety of the DaRT seeds for the treatment of advanced pancreatic cancer. The study will be comprised of a ...