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2023-05-01
2025-04-22
2025-04-22
6
NCT05880472
Radboud University Medical Center
Radboud University Medical Center
INTERVENTIONAL
Percutaneous Holmium Injection in Pancreatic Cancer
This investigator initiated study with a medical device aims to assess the safety and feasibility of percutaneous injected holmium-166 microsphere brachytherapy in patients with irresectable pancreatic cancer.
Objective: To test the feasibility and safety of minimally invasive CT-guided percutaneous holmium-166 microsphere brachytherapy in patients suffering from irresectable pancreatic cancer. Study design: This is a single centre, prospective, safety and feasibility study with a medical device in a maximum of 6 patients. Study population: Patients diagnosed with pathologically proven pancreatic adenocarcinoma, who are ineligible for exploratory surgery or surgical resection of the tumour after 8 cycles of systemic therapy or less in case of unacceptable toxicity, patient refusal or patients who are ineligible for systematic therapy. Intervention (if applicable): A radioactive medical device will be implanted by CT-guided percutaneous injection. The medical device in question are beta-minus (β-) and gamma(γ) emitting holmium-166 poly(L-lactic acid) microspheres (166Ho-PLLA-MS, HoMS) in a 0.1% Pluronic or cellulose based suspension. Main study parameters/endpoints: The main endpoint is to establish the feasibility and safety of CT-guided percutaneous intratumoural implantation of HoMS in irresectable pancreatic adenocarcinoma. Feasibility is established by evaluating the average tumour absorbed dose in Gray (Gy) calculated on SPECT and comparing to the pre-operative planning. Intratumoural microsphere distribution, absorbed tumour dose and non-target absorbed tumour dose are analysed using MRI and CT quantification. Safety is evaluated using the Common Terminology Criteria for Adverse Events (CTCAE v5.0), events deemed 'unlikely', 'probably' or 'definitely' related to the implantation procedure or implanted medical device. As exploratory endpoints, tumour response (RECIST1.1), pain (NRS) and Quality of Life is evaluated. Total follow-up is 16 weeks.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-05-09 | N/A | 2025-02-07 |
2023-05-19 | N/A | 2025-02-11 |
2023-05-30 | N/A | 2025-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Intervention arm Single or multiple injections of holmium-166 microspheres (up to 150 Gy) in a single session. Intervention is not repeated. | DEVICE: Intratumoral
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Average tumour dose (Gy) by SPECT/CT | Tumour and non-tumour dose is estimated by SPECT using after intervention to assess feasibility. | Within 24 hours post-intervention |
| Number of adverse event per patient per grade by CTCAE v5.0 | Number and grade of adverse events per patient by Common Terminology Criteria for Adverse Events (CTCAE v5.0) between grade 0 (mild complication) to grade 5 (death) deemed 'unlikely', 'probably', or 'definitely' related to the implantation procedure or medical device implanted. | Up to 16 weeks post-intervention |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Average tumour dose (Gy) by MRI quantification | <24 hour and 16 weeks post-intervention | |
| Average tumour dose (Gy)by CT quantification | <24 hour and 16 weeks post-intervention | |
| Microsphere distribution (percentage covered) of 3D target area | By CT or MRI to assess dose coverage | <24 hour and 16 weeks post-intervention |
| Injection percentage (%) | Implant efficiency | Immediately after the intervention |
| Needle tip position off-target (mm) | implant accuracy | Immediately after the intervention |
| Operator hand and total body dose (mSv) | Operator safety | Immediately after the intervention |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
