Pancreatic Cancer Non-resectable
Conditions
Brief summary
This clinical study aims to evaluate the safety and tolerability of intra-arterial Yttrium-90 (90Y) glass microspheres in patients with unresectable pancreatic adenocarcinoma. The study will assess radiation dose distribution, adverse effects, and preliminary efficacy following selective arterial radioembolization.
Detailed description
Pancreatic adenocarcinoma remains one of the most lethal malignancies, with limited treatment options for patients with advanced disease. While systemic chemotherapy provides modest survival benefits, targeted radioembolization using Yttrium-90 microspheres offers a novel approach for selective tumour irradiation. This study is designed to evaluate the feasibility, safety, and preliminary therapeutic response of selective intra-arterial 90Y administration. Patients will undergo pre-treatment imaging and dose-planning via SPECT/CT with 99mTc-labeled macroaggregated albumin (MAA) to assess microsphere distribution. Following this, radioembolization will be performed with escalating activity levels in small patient cohorts. Post-therapy imaging and dosimetry assessments will be conducted to evaluate tumour response and organ radiation exposure.
Interventions
Selective intra-arterial infusion of Yttrium-90 (90Y) glass microspheres into the pancreatic tumor via catheterization of tumor-feeding arteries. The intervention involves pre-treatment dosimetry planning using 99mTc-MAA SPECT/CT, followed by sequential dose escalation of 90Y activity corresponding to absorbed doses. Post-therapy imaging (SPECT/CT) will be performed to assess microsphere distribution and radiation dosimetry.
Sponsors
National Medical Research Radiological Centre of the Ministry of Health of Russia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed pancreatic adenocarcinoma (T4N0/1M0/1) * ECOG performance status 0-1, for at least 2 weeks * Life expectancy ≥12 weeks * Signed informed consent for participation
Exclusion criteria
* ECOG \>2 or Karnofsky score \<60% * Active gastrointestinal ulcers or recent GI bleeding (\<3 months) * Active Hepatitis B/C or other significant infectious disease * Uncontrolled cardiovascular disease (NYHA class III/IV heart failure, recent MI, severe arrhythmias) * Significant haematological abnormalities (ANC \<1.5×10⁹/L, platelets \<100×10⁹/L, haemoglobin \<8 g/dL) * Severe hepatic dysfunction (total bilirubin \>1.5×ULN, ALT/AST \>4×ULN without liver metastases) * Prior solid organ transplant * Pregnancy or lactation * Any condition deemed by investigators as unsafe for participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability | Perioperatively, up to 8 weeks | Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) per CTCAE v5.0 Post-embolization syndrome incidence (pain, fever, nausea) |
| Radiation dosimetry and distribution | Immediately after the intervention | Absorbed radiation dose in tumour and organs-at-risk (OARs) measured via post-therapy SPECT/CT Shunting assessment to non-target organs (lungs, GI tract) |
| Preliminary tumour response | 8 weeks | Changes in tumour size per RECIST 1.1 criteria Metabolic response via FDG-PET/CT CA 19-9 biomarker dynamics |
Countries
Russia
Contacts
CONTACTArtur Petrosian
Outcome results
None listed