Radioactive implant targets pancreatic tumors from the inside
NCT ID NCT07155850
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early study tests a new device called YntraDose™ that delivers a single dose of radiation directly into pancreatic tumors that cannot be removed by surgery. Ten participants will receive the implant along with standard chemotherapy. The main goals are to see if the procedure is safe and feasible, and to measure its impact on tumor response and quality of life over three months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Y-90 microspheres (radioactive implant) delivered via YntraDose™ device
- What this could lead to
- If it works, this could offer a new way to treat inoperable pancreatic cancer by delivering radiation directly into the tumor, potentially improving tumor control and quality of life.
- What could go wrong
- This is a very early, small study (10 people) focused on safety and feasibility. It may not show clear benefit, and there are risks from the procedure and radiation, including possible damage to nearby organs.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria (Main): * Histologically or cytologically proven Pancreatic Adenocarcinoma. * Stage of disease defined as unresectable Locally Advanced Pancreatic Cancer. * No prior radiotherapy for pancreatic cancer. * Target tumour with a minimum diameter of 2.6 cm and a volume of from 9 to 34 ml. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Patient has acceptable hematological parameters including white and red blood counts, liver and renal function that makes them suitable to receive SoC chemotherapy as per local clinical practice. * Life expectancy of ≥6 months at screening. Exclusion Criteria (Main): * Evidence of distant metastases based on the restaging process after two months of induction chemotherapy identified using CT/MRI/18 FDG PET assessment. * Evidence of switch from unresectable status to resectable status of disease after two months of induction chemotherapy. * More than one primary lesion, if one of the primary lesions is not a good candidate for debulking with YntraDose™, due to clinical reasons and/or decision made by the local MDTB. * ECOG is higher than 1. * History of malignancy in the last 3 years. * Blood clotting disorders (INR \> 1.5, PLT \< 50,000/µl - risk of bleeding during organ puncture). * Active systemic or local infection (e.g. peritonitis, abscess). * Severe organ failure (e.g. end-stage liver, kidney, heart failure). * Cardiological and other diseases that threaten the use of anesthesia. * Pancreatitis (acute or exacerbation of chronic inflammation).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fondazione Policlinico Universitario A. Gemelli, IRCCS
RECRUITINGRoma, Italy
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Guy's & St Thomas' and Kings College Hospitals
RECRUITINGLondon, United Kingdom
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