Tiny radiation seeds take aim at tough pancreatic cancer
NCT ID NCT06026943
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new device that delivers a special type of radiation directly into pancreatic tumors. It is for people with advanced pancreatic cancer that cannot be removed by surgery. The main goals are to see if the procedure is safe and possible to do. About 15 participants will be enrolled.
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
-
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
-
About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2026
- Expected to finish
-
Jan 2028
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 to 120 years
- Sex
-
Anyone
- Healthy volunteers
-
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: * Histologically and/or cytologically proven NCCN locally advanced PC * Patients must have i) received at least one line of chemotherapy (any kind) OR ii) are medically unfit for further chemotherapy, AND iii) the tumor is still not deemed as resectable with radical surgery, or the patient does not wish to go through surgery. * DaRT indication validated by a multidisciplinary team. * Measurable lesion per RECIST (version 1.1) criteria * TC at Verona's center (not been over a month) * Lesion size ≤ 5 cm in the longest diameter * Age ≥18 years old * ECOG Performance Status Scale ≤ 2 * Life expectancy is more than 6 months * WBC ≥ 3500/μl, granulocyte ≥ 1500/μl * Platelet count ≥60,000/μl * Calculated or measured creatinine clearance ≥ 30cc/min. Calculated or measured creatinine clearance can be ≥ 40cc/min given stability of creatinine levels over the past three weeks (at least 1 test per week). * AST and ALT ≤ 2.5 X upper limit of normal (ULN) * INR \< 1.4 for patients not on Warfarin * Subjects are willing and able to sign an informed consent form * Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after brachytherapy. * Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy. Exclusion Criteria: * Concomitant chemotherapy or immunotherapy within the past 4 weeks * Prior radiation therapy to the pancreas * CA 19-9 \> 1000 Units/ml * Fit for surgical exploration unless the patient refuses surgery * Known hypersensitivity to any of the components of the treatment. * Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids. * Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months. * Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy (not including cholangitis) or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints. * Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. * Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT. * Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy. * Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT. * High probability of protocol non-compliance (in opinion of investigator). * Breastfeeding women or women of childbearing potential unwilling or unable to use an acceptable contraceptive method to prevent pregnancy for 3 months after RT.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Pancreatic adenocarcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Chirurgia Generale e del Pancreas, Istituto del Pancreas
RECRUITINGVerona, Italy
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a blood test before pancreatic surgery predict a dangerous leak?
- New chemo cocktail targets pancreatic cancer at every stage
- Bacteria-Based immunotherapy targets pancreatic tumors in first human test
- Can a new radiation machine cut breath holds for cancer patients?
- Two oral drugs join chemotherapy in a bid to shrink pancreatic tumors
- Nerve-Block procedure tested against severe pancreatic and stomach cancer pain