Implantable Microdevice for Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a tiny implantable device to understand how pancreatic cancer responds to different drugs. Surgeons place the device in the tumor during surgery and later remove it to observe how the drugs spread and affect the cancerous tissue. The trial aims to determine if this implantable microdevice is safe and if it can help doctors select better treatments for pancreatic cancer. Individuals with a pancreatic lesion requiring surgery and who qualify for specific types of surgery may be suitable for this trial. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking advancements in cancer treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this implantable microdevice is safe for pancreatic cancer patients?
Research has shown that implantable microdevices are generally well-tolerated in cancer studies. In one study with pancreatic cancer patients, a similar microdevice safely and effectively delivered drugs directly to tumors (source 1). Another study described these devices as a safe alternative for local drug delivery after surgery (source 2). Although these studies are in the early stages, they suggest that the microdevice does not cause significant side effects.
The current study is in an early phase, focusing on safety and identifying potential risks. As this is a new area of research for pancreatic cancer, safety information is still being gathered. However, initial findings are promising, with no major side effects reported in similar studies. Patients interested in participating should consult their healthcare provider about the potential risks and benefits.12345Why are researchers excited about this trial?
Researchers are excited about the implantable microdevice for pancreatic cancer because it introduces a novel delivery method. Unlike traditional treatments like chemotherapy or radiation, which affect the whole body, this microdevice is implanted directly into the tumor. It allows localized delivery of cancer-fighting agents right at the source, potentially increasing effectiveness while reducing harmful side effects. This precision targeting could revolutionize how pancreatic cancer is treated, offering new hope for improved outcomes.
What evidence suggests that this implantable microdevice is effective for pancreatic cancer?
Research has shown that tiny devices placed inside the body, called implantable microdevices, may help understand how pancreatic cancer responds to treatment. In earlier studies, these devices accurately predicted drug effectiveness in animals. For example, one study demonstrated that these devices could identify effective treatments for pancreatic cancer in mice. Another study showed that using a microdevice could enhance chemotherapy by delivering drugs directly to the tumor. These early results suggest that microdevices might help identify the best treatment options for pancreatic cancer patients. However, more research is needed to confirm their effectiveness in humans. In this trial, all participants will receive the implantable microdevice to assess its safety and feasibility in humans.26789
Are You a Good Fit for This Trial?
This trial is for adults (18+) with a suspicious or confirmed pancreatic tumor who are scheduled for surgery to remove it. Participants must be able to consent, not pregnant, willing to use contraception, and have tumors in locations suitable for device placement. People with advanced or metastatic cancer or other interfering cancers can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intraoperative Device Placement
Intraoperative placement and retrieval of a microdevice in patients with pancreatic cancer. The devices will be implanted intra-operatively and removed en-bloc with the tumor after a 4-hour incubation period.
Postoperative Monitoring
Patients are monitored to ensure that the placement and retrieval of these devices does not increase complication rates within one month of surgery.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including analysis of tissue surrounding the microdevices to determine drug diffusion and impact.
What Are the Treatments Tested in This Trial?
Interventions
- Implantable Microdevice
Trial Overview
The study tests the safety of implanting a tiny device into the pancreas during surgery. This device releases small amounts of chemotherapy drugs directly into the tumor so doctors can see how the cancer responds before removing it. The main goal is to check if this procedure causes any extra complications.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
This is a single institution pilot study to be performed on a limited number of patients (10) to establish safety and feasibility. There will be only one cohort of patients included and one intervention, the insertion of the microdevice prior to resection of the specimen with the device implanted. All patients will receive this intervention, thereby eliminating any potential bias on confounders.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwell Health
Lead Sponsor
Citations
Biodegradable gemcitabine-loaded microdevice with ... - PMC
At present, the 10-year survival rate of patients with pancreatic cancer is still less than 4%, mainly due to the high cancer recurrence rate caused by ...
Feasibility of implantable microdosing devices to perform in ...
Conclusions: Utilization of implantable microdevice to predictcancer drug sensitivity is feasible in organoid transplantation animal models of ...
Pilot study of an implantable microdevice for in situ ...
Pilot study of an implantable microdevice for in situ evaluation of drug response in patients with pancreatic cancer. Standring, Oliver, ...
Implantable Microdevices for In Vivo Assessment of ...
OBJECTIVE: To investigate the feasibility of using implantable microdevices (IMDs) in pancreatic ductal adenocarcinoma (PDAC).
Abstract CT090: Pilot study of an implantable microdevice ...
Abstract CT090: Pilot study of an implantable microdevice for in situ evaluation of drug response in patients with pancreatic cancer · Abstract.
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aacrjournals.org
aacrjournals.org/cancerres/article/86/8_Supplement/CT090/782816/Abstract-CT090-Pilot-study-of-an-implantableAbstract CT090: Pilot study of an implantable microdevice for ...
Abstract CT090: Pilot study of an implantable microdevice for in situ evaluation of drug response in patients with pancreatic cancer Available.
Review article Enhancing pancreatic cancer immunotherapy
The use of implantable devices and scaffolds presents a unique opportunity to reconsider immunotherapies previously dismissed due to safety concerns. In ...
NONINVASIVE CHARACTERIZATION AND ...
Pancreatic ductal adenocarcinoma is an especially deadly disease having the lowest 5-year survival rate of any major cancer at just 11%. As in many cancers, ...
A multiplex implantable microdevice assay identifies ...
In this study, we integrated high-throughput and high-content techniques—an implantable microdevice to administer multiple drugs into different ...
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