Pancreatic CancerEarly Phase 1NCT07254091
Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Pancreatic Cancer
A Early Phase 1 study testing Device Arm with Therapeutic Agents in people with Pancreatic Cancer, run by Northwell Health at 1 site in United States.
Trial summary
Predicting drug response offers an opportunity to improve cancer treatment delivery. Recently, microdevices were invented to ascertain in vivo drug response but have not yet been evaluated for pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Device Arm with Therapeutic Agents
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2026to 30 Jan 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be at least or greater than18 years old
- All sexes, genders, races, and ethnic groups are eligible for this trial
- Patients with a suspicious or histologically confirmed pancreatic lesion for which surgery is indicated for either diagnostic or therapeutic purposes, as determined by the treating surgeon
- Patients must be a candidate for pancreatoduodenectomy or pancreatectomy
- Patients must be evaluated by the operating Surgical Oncologist to determine the feasibility of microdevice implantation based on clinical history, extent, and anatomical location of the tumor seen on baseline imaging
- The effects of the microdevice on the developing human fetus is unknown. For this reason and because the therapeutic agents used in this trial are known to be teratogenic, women of childbearing age must agree to have a negative serum pregnancy test within 48 hours prior to operation.
- Patient must be willing and able to understand and sign informed consent for both the surgical resection as well as the proposed research study obtained prior to any procedures
- Males and females of childbearing potential must agree to use effective contraception starting prior to the first day of treatment and continuing for 30 days after the implantation of the microdevice. Additionally, due to the unknown but potential risks of nursing infants secondary to the treatment of the mother with the chemotherapeutic agents used in this study, breastfeeding should be discontinued for a total of 14 days after the insertion of the microdevice.
Who cannot join
- Patients with a tumor in a location not amenable to placement of the device prior to the removal of the tumor specimen as determined by the Surgical Oncologist
- Any patient that is pregnant at the time of enrollment or operative intervention is excluded due to the known teratogenicity of the medications involved.
- Patients with a history of prior or concurrent second primary malignancy whose natural history or treatment has the potential to interfere with the safety or primary endpoint efficacy assessment of the pancreas cancer
- Patients with metastatic or locally advanced disease on baseline imaging
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Zuckerberg Cancer Center
New Hyde Park, New York, 11040
About this study
Predicting drug response offers an opportunity to improve cancer treatment delivery. Recently, microdevices were invented to ascertain in vivo drug response but have not yet been evaluated for pancreatic cancer. This study is a prospective phase 1 safety study of 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. Patients will be monitored to ensure that the placement and retrieval of these devices does not increase complication rates within one month of surgery. To assess feasibility, the tissue surrounding the microdevices is then analyzed to determine the diffusion of drugs from the device(s) to surrounding tissue, and whether the chemotherapeutic effect of diffusing chemotherapy drug has an impact on the surrounding tissue. In an exploratory analysis, material from the patient's tumors will be grown into organoids and drug response correlation from organoids will be compared to the response observed from the microdevices.
- Conditions
- Pancreatic Cancer
- Being tested
- Device Arm with Therapeutic Agents
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device Arm with Therapeutic AgentsCombination product
Devices manufactured by the Jonas Lab containing microdoses (1/100,000th standard dosage) of chemotherapy agents will be implanted and remain in situ for 4 hours, after which resection of the tumor and corresponding microdevice(s) are removed. The chemotherapeutic agents include Doxorubicin, Gemcitabine , Paclitaxel, 5 Fluorouracil , Oxaliplatin, and Irinotecan.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | 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. Receives: Combination Product: Device Arm with Therapeutic Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of micro dosing devices placement and retrieval based on adverse events by assessment of adverse events as defined in the CTCAE v5.0.
Safety will be defined by assessment of adverse events as defined in the CTCAE v5.0.
Any device resulting in:
- any listed Serious adverse events as defined in section 8.3.2, or
- two or more grade 3-4 adverse events directly associated with the device or its placement as defined in section 8.3.3.2
Measured: 1 year
Secondary outcomes (1)
1. To determine the feasibility of microdevice analysis after the intra-operative placement and retrieval of the devices with sufficient associated tissue for histopathologic assessment of drug sensitivity.
To determine the feasibility of microdevice placement and retrieval based on the ability to retrieve the device with sufficient tissue, of sufficient quality , for downstream histopathology analysis and interpretation of at least 50% of the device reservoirs
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start30 Jan 2026
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Weiss, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254091
- Sponsor's protocol ID
- 23-0695
- Status last verified
- Oct 2026
- First submitted
- 19 Nov 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07254091
- Acronym / sponsor ID
- 23-0695
- Conditions
- Pancreatic Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Predicting drug response offers an opportunity to improve cancer treatment delivery. Recently, microdevices were invented to ascertain in vivo drug response but have not yet been evaluated for pancreatic cancer. This study is a prospective phase 1 safety study of 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. Patients will be monitored to ensure that the placement and retrieval of these devices does not increase complication rates within one month of surgery. To assess feasibility, the tissue surrounding the microdevices is then analyzed to determine the diffusion of drugs from the device(s) to surrounding tissue, and whether the chemotherapeutic effect of diffusing chemotherapy drug has an impact on the surrounding tissue. In an exploratory analysis, material from the patient's tumors will be grown into organoids and drug response correlation from organoids will be compared to the response observed from the microdevices.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Combination Product: Device Arm with Therapeutic AgentsThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must be at least or greater than18 years old
- All sexes, genders, races, and ethnic groups are eligible for this trial
- Patients with a suspicious or histologically confirmed pancreatic lesion for which surgery is indicated for either diagnostic or therapeutic purposes, as determined by the treating surgeon
- Patients must be a candidate for pancreatoduodenectomy or pancreatectomy
- Patients must be evaluated by the operating Surgical Oncologist to determine the feasibility of microdevice implantation based on clinical history, extent, and anatomical location of the tumor seen on baseline imaging
Key exclusion criteria (4 listed)
- Patients with a tumor in a location not amenable to placement of the device prior to the removal of the tumor specimen as determined by the Surgical Oncologist
- Any patient that is pregnant at the time of enrollment or operative intervention is excluded due to the known teratogenicity of the medications involved.
- Patients with a history of prior or concurrent second primary malignancy whose natural history or treatment has the potential to interfere with the safety or primary endpoint efficacy assessment of the pancreas cancer
- Patients with metastatic or locally advanced disease on baseline imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device Arm with Therapeutic AgentsDevices manufactured by the Jonas Lab containing microdoses (1/100,000th standard dosage) of chemotherapy agents will be implanted and remain in situ for 4 hours, after which resection of the tumor and corresponding microdevice(s) are removed. The chemotherapeutic agents include Doxorubicin, Gemcitabine , Paclitaxel, 5 Fluorouracil , Oxaliplatin, and Irinotecan. | Combination product | Single Arm |
Primary outcome
To evaluate the safety of micro dosing devices placement and retrieval based on adverse events by assessment of adverse events as defined in the CTCAE v5.0.
Time frame: 1 year
Safety will be defined by assessment of adverse events as defined in the CTCAE v5.0. Any device resulting in: * any listed Serious adverse events as defined in section 8.3.2, or * two or more grade 3-4 adverse events directly associated with the device or its placement as defined in section 8.3.3.2
1 secondary outcome
1. To determine the feasibility of microdevice analysis after the intra-operative placement and retrieval of the devices with sufficient associated tissue for histopathologic assessment of drug sensitivity.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Device Arm with Therapeutic Agents in people with Pancreatic Cancer, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GI Trial Referral Team ((516) 734-8900, gitrialreferral@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety of micro dosing devices placement and retrieval based on adverse events by assessment of adverse events as defined in the CTCAE v5.0. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.