What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer include surgery, chemotherapy, and radiation therapy. Side effects of chemotherapy can include nausea, vomiting, fatigue, hair loss, and increased risk of infection. Radiation therapy side effects may involve skin irritation, fatigue, nausea, and changes in bowel habits. For treatments similar to the Intratumoral Diffusing Alpha Radiation Emitter Device, which uses localized alpha radiation, potential side effects could include localized pain, inflammation, and damage to surrounding tissues. However, alpha radiation's high energy and short travel distance aim to minimize toxicity to normal tissues compared to other radiation types.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, including chemotherapeutic agents like gemcitabine and nab-paclitaxel, which are often used in combination. While the context does not mention specific FDA approvals for treatments similar to the Intratumoral Diffusing Alpha Radiation Emitter Device, this device represents a novel approach focusing on localized alpha radiation emission to target and kill cancer cells directly within the tumor. This method is distinct from traditional systemic therapies and highlights the ongoing innovation in pancreatic cancer treatment.

What other types of research exist?

Promising novel alternatives for pancreatic cancer treatment in 2024 include: 1) Pharmacologic inhibition of histone demethylation, 2) Chimeric Antigen Receptor (CAR)-expressing T cells targeting GD2, 3) ONC201, an investigational oral compound under active investigation for H3 K27-altered gliomas, and 4) DNX-2401, an oncolytic adenovirus administered by catheter infusion. These therapies are in various stages of clinical trials and have shown potential in treating other aggressive cancers, which may translate to pancreatic cancer treatment.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years following dart seeds insertion

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

0 / 10Eligibility criteria met

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.