Your session is about to expire
← Back to Search
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 belowSelect...
I am 18 years old or older.
Select...
My cancer is advanced or has spread and is a type of pancreatic cancer.
Select...
My largest cancer area is 4cm or smaller.
Select...
My pancreatic cancer cannot be removed by surgery.
Select...
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:Select...
I am not pregnant or breastfeeding.
Select...
I have had radiation therapy to my abdomen before.
Select...
My pancreatic cancer can possibly be removed by surgery and I am healthy enough for the operation.
Select...
I have a connective tissue disease like scleroderma or lupus.
Select...
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
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 moreAwards & 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.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or breastfeeding.I am 18 years old or older.You are expected to live for at least 12 more weeks.You have other health conditions that might affect the goals of the study, such as autoimmune diseases or vasculitis.I am not on long-term immunosuppressive drugs, except for short-term steroids.I have had radiation therapy to my abdomen before.My cancer is advanced or has spread and is a type of pancreatic cancer.I have had chemotherapy before.My largest cancer area is 4cm or smaller.My pancreatic cancer can possibly be removed by surgery and I am healthy enough for the operation.My pancreatic cancer cannot be removed by surgery.I have a connective tissue disease like scleroderma or lupus.You have a tumor that can be measured according to specific guidelines.I can take care of myself but might not be able to do heavy physical work.Women who could become pregnant need to have a negative pregnancy test.I am currently receiving chemotherapy or immunotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: DaRT Seeds
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger