2021-12-13
2024-02-18
2024-02-18
3
NCT05191498
Radboud University Medical Center
Radboud University Medical Center
INTERVENTIONAL
Intratumoral Holmium Microspheres Brachytherapy for Patients With Pancreatic Cancer
This is a feasibility study in which patients with pancreatic cancer are treated with intratumoral holmium microsphere injections.
N/A
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 |
|---|---|---|
2022-01-02 | N/A | 2024-04-09 |
2022-01-02 | N/A | 2024-04-11 |
2022-01-13 | N/A | 2023-05 |
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: Study patients All patients receive intratumoral holmium microsphere injections ones, if surgery is suspended. Patient specific treamtent planning is performed for every individual patient. | DEVICE: QuiremSpheres®
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Average tumour dose by SPECT imaging | To establish the feasibility of intratumoral implantation of QuiremSpheres® by evaluating the average tumour absorbed dose in Gy calculated on SPECT. | At 1 week after intervention |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Microsphere distribution by MRI | Microsphere distribution in analysed using MRI to evaluate tumour absorbed and non-target absorbed dose. | At 1 week after intervention |
| Microsphere distribution by CT | Microsphere distribution in analysed using CT to evaluate tumour absorbed and non-target absorbed dose. | At 1 week after intervention |
| Number of treatment-related adverse events as assessed by CTCAE v4.0 | Safety, expressed in Common Terminology Criteria for Adverse Events, grade 3 and higher, probably or definitely related to the implantation procedure or medical device implant is monitored up to 3 months after intervention. | Up to 3 months after intervention |
| Tumor response by RECIST 1.1 | Tumor response to the intervention is evaluated according to the Response evaluation criteria in solid tumors (RECIST) version 1.1 after 3 months. | At 3 months after 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
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