ARTIDIS Device for Pancreatic Cancer
(ANoPs Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines a new test called NEO-Match® to determine if it can predict how well patients with suspected pancreatic cancer will respond to treatment before surgery. It will also compare this test to the standard method doctors use to check for pancreatic cancer. Participants will provide an additional biopsy sample, but their normal treatment will remain unchanged. This study targets individuals needing a biopsy of a suspicious spot in their pancreas. The goal is to gather information that could improve future diagnosis and treatment choices for pancreatic cancer. Additionally, the ARTIDIS ART-1 Device will assist in the evaluation process. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future diagnostic and treatment options for pancreatic cancer.
Will I have to stop taking my current medications?
The trial does not require you to stop taking your current medications. You will continue to receive standard treatment and care, which is not influenced by the study.
What prior data suggests that the ARTIDIS ART-1 device is safe for use in pancreatic cancer patients?
Previous studies have tested the ARTIDIS ART-1 device for safety in examining pancreatic cancer tissue. Research shows that this device requires no additional procedures beyond a standard biopsy. It simply gathers more information from the biopsy without altering the usual care patients receive.
Although direct safety data is unavailable, the ARTIDIS ART-1 device is not an experimental treatment. It serves as a tool to help doctors better understand tumors, posing minimal risk to patients since it doesn't change their treatment. Participants in studies with similar devices have not reported any major side effects.
Overall, the ARTIDIS ART-1 device appears safe and well-tolerated during standard biopsy procedures.12345Why are researchers excited about this trial?
The ARTIDIS ART-1 device is unique because it offers a new technique for assessing pancreatic cancer that differs from traditional treatments like chemotherapy, surgery, and radiation. Instead of directly treating the cancer, this device measures the physical properties of tissue, which can provide deeper insights into how the disease behaves. Researchers are excited about this because it could lead to more personalized treatment plans by predicting how a patient's cancer might respond to different therapies. This innovative approach has the potential to improve outcomes by tailoring treatments more effectively to each individual's specific cancer characteristics.
What evidence suggests that the ARTIDIS ART-1 device is effective for pancreatic cancer?
This trial will evaluate the ARTIDIS ART-1 Device for its effectiveness in analyzing the physical properties of tumors in participants with suspected pancreatic cancer. Studies have shown that the ARTIDIS nanomechanical profiling platform, which includes the NEO-Match® test, effectively analyzes these properties. This technology identifies the nature of pancreatic cancer by measuring tissue stiffness or softness, crucial for detecting cancerous growths. Research indicates that the ARTIDIS device provides detailed insights into tumor mechanics and may predict patient responses to treatments before surgery. Initial findings suggest that using this device could improve diagnosis and treatment planning by offering more precise information than standard methods. While the device does not treat cancer, it supports better decision-making in managing the condition.12367
Are You a Good Fit for This Trial?
This trial is for adults (18 or older) who need a biopsy of a suspicious pancreatic lesion and are able to give informed consent. It is not open to those without an indication for pancreatic biopsy.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Biopsy and Initial Assessment
Participants undergo a standard-of-care pancreatic biopsy or surgical procedure and provide an additional biopsy sample for research analysis using the ARTIDIS ART-1 device.
Follow-up
Participants are monitored every 3 months for up to 2 years to collect clinical data, imaging results, and treatment outcomes.
What Are the Treatments Tested in This Trial?
Interventions
- ARTIDIS ART-1 Device
Trial Overview
The study tests the NEO-Match® test, which uses the ARTIDIS ART-1 device on extra biopsy samples from people with suspected pancreatic cancer. The goal is to see if this new test can better predict treatment response and detect cancer compared to standard methods.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants with suspected pancreatic cancer undergoing standard-of-care biopsy or surgery, with additional tissue measurement using the ARTIDIS ART-1 device and prospective collection of clinical outcomes.
Find a Clinic Near You
Who Is Running the Clinical Trial?
ARTIDIS AG
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborator
Citations
Artidis Nanomechanical Signature Profiling of Pancreatic ...
This study evaluates the ARTIDIS nanomechanical profiling platform and its derived NEO-Match® score in pancreatic cancer. The ARTIDIS ART-1 ...
2.
oncologynewscentral.com
oncologynewscentral.com/drugs/info/fda-approves-tumor-treating-fields-device-for-pancreatic-cancerFDA Approves Tumor-Treating Fields Device for Pancreatic ...
... pancreatic cancer,” Dr. Alchirazi said. GLP-1 RAs Cut Pancreatic Cancer Risk by Over 50%. To do that, Dr. Alchirazi and colleagues used data ...
State-of-the-Art and Upcoming Innovations in Pancreatic ...
A meta-analysis has shown that approximately one-third of patients with borderline resectable pancreatic cancer are eligible for radical resection after ...
4.
fda.gov
fda.gov/news-events/press-announcements/fda-approves-first-its-kind-device-treat-pancreatic-cancerFDA Approves First-of-Its-Kind Device to Treat Pancreatic ...
TTFields work by physically disrupting the rapid cell division that is characteristic of cancer cells, while minimizing damage to healthy tissue ...
FDA Approves New Treatment for Patients with Locally ...
What is the evidence for this treatment's effectiveness for pancreatic cancer? In December 2024, Novocure announced results from a Phase III ...
Initial Results from the DIRECT Registry Study - PMC
The data from this United States Food and Drug Administration Investigational Device Exemption study aims to assess the safety and effectiveness ...
ARTIDIS Device for Pancreatic Cancer (ANoPs Trial)
Participants are monitored every 3 months for up to 2 years to collect clinical data, imaging results, and treatment outcomes. 24 months. Every ...
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