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Radiopharmaceutical

Alpha Radiation Device for Advanced Pancreatic Cancer

N/A
Recruiting
Led By David Donath, 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
≥ 18 years of age
Histologically and/or cytologically proven locally advanced (Stage II or III) or metastatic (Stage IV) pancreatic, adenocarcinoma
Must not have
Women who are pregnant or lactating
Prior abdominal radiation therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years following dart seeds insertion
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new treatment for advanced pancreatic cancer using tiny devices that emit special radiation directly into the tumor. The goal is to see if this method is safe and effective. The radiation aims to kill cancer cells by damaging their DNA, preventing them from growing and spreading.

Who is the study for?
Adults over 18 with advanced pancreatic cancer that can't be removed by surgery due to its spread or patient's health. They must have a life expectancy of at least 12 weeks, an ECOG performance status ≤ 2 (meaning they are up and about more than half the day), and a tumor no larger than 4cm. Pregnant women, those unwilling to consent, or patients with certain serious diseases cannot participate.
What is being tested?
The trial is testing DaRT, a new type of radiation therapy placed directly into the tumor in patients with advanced pancreatic cancer. It aims to see how well this local treatment works on tumors that can't be surgically removed.
What are the potential side effects?
Potential side effects may include localized pain or discomfort at the treatment site, skin reactions similar to sunburns, fatigue from radiation exposure, and possible harm to surrounding healthy tissue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My cancer is advanced or has spread and is a type of pancreatic cancer.
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My largest cancer area is 4cm or smaller.
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My pancreatic cancer cannot be removed by surgery.
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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant or breastfeeding.
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I have had radiation therapy to my abdomen before.
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My pancreatic cancer can possibly be removed by surgery and I am healthy enough for the operation.
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I have a connective tissue disease like scleroderma or lupus.
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I am currently receiving chemotherapy or immunotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years following dart seeds insertion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years following dart seeds insertion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility - DaRT seed placement
Safety - Adverse events
Secondary study objectives
Change in quality of life: EORTC-QLQ-C30
Change in quality of life: QLQ-PAN26
Efficiency - Long-term effect
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
2017
N/A
~30

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for pancreatic cancer include surgery, chemotherapy, radiation therapy, and targeted therapies. Surgery aims to remove the tumor and surrounding tissues, potentially curing the patient if the cancer is localized. Chemotherapy uses drugs to kill rapidly dividing cancer cells, but it can also affect healthy cells, leading to side effects. Radiation therapy uses high-energy particles to damage the DNA of cancer cells, inhibiting their ability to reproduce. Targeted therapies focus on specific molecular targets associated with cancer, minimizing damage to normal cells. The Intratumoral Diffusing Alpha Radiation Emitter Device represents a novel approach by delivering high-energy alpha particles directly into the tumor, causing localized damage to cancer cells while sparing surrounding healthy tissue. This localized approach is particularly important for pancreatic cancer patients due to the typically late diagnosis and the tumor's proximity to vital structures, making precise treatment crucial.
Current and future intratumoral targeted treatment for pancreatic cancer.

Find a Location

Who is running the clinical trial?

Alpha Tau Medical LTD.Lead Sponsor
25 Previous Clinical Trials
811 Total Patients Enrolled
David Donath, MDPrincipal InvestigatorBrachytherapy Service Centre Hospitalier de l'Université de Montreal
Corey Miller, MDPrincipal InvestigatorDivision of Gastroenterology, Jewish General Hospital

Media Library

Diffusing Alpha Radiation Emitters Therapy (DaRT) (Radiopharmaceutical) Clinical Trial Eligibility Overview. Trial Name: NCT04002479 — N/A
Pancreatic Cancer Research Study Groups: DaRT Seeds
Pancreatic Cancer Clinical Trial 2023: Diffusing Alpha Radiation Emitters Therapy (DaRT) Highlights & Side Effects. Trial Name: NCT04002479 — N/A
Diffusing Alpha Radiation Emitters Therapy (DaRT) (Radiopharmaceutical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04002479 — N/A
~7 spots leftby Nov 2025