Pancreatic Cancer Non-resectablePhase 1NCT07898683
A Phase I Study of Intra-Arterial Yttrium-90 Radioembolization for Unresectable Pancreatic Cancer
A Phase 1 study testing Transarterial Radioembolization in people with Pancreatic Cancer Non-resectable, run by National Medical Research Radiological Centre of the Ministry of Health of Russia at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer Non-resectable
- What is being tested?
- Transarterial Radioembolization
- Type of treatment
- Injection or infusion
- How many people
- 12 participants
- Where
- 1 siteRussia
- Study dates
- 11 Feb 2025to Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- Prior solid organ transplant
- Pregnancy or lactation
- Any condition deemed by investigators as unsafe for participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Medical Radiological Research Center named after A.F. Tsyb (MRRC) - National Medical Research Center of Radiology
Obninsk
Artur Petrosian, +79533162464, 79533162464@yandex.ru
About this study
Official title: Selective Intra-Arterial Yttrium-90 Radioembolization for the Treatment of Unresectable Pancreatic Adenocarcinoma: A Phase I Clinical Trial
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.
Read the 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.
- Conditions
- Pancreatic Cancer Non-resectable
- Being tested
- Transarterial Radioembolization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transarterial RadioembolizationOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) per CTCAE v5.0 Post-embolization syndrome incidence (pain, fever, nausea)
Measured: Perioperatively, up to 8 weeks
Radiation dosimetry and distribution
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)
Measured: Immediately after the intervention
Preliminary tumour response
Changes in tumour size per RECIST 1.1 criteria Metabolic response via FDG-PET/CT CA 19-9 biomarker dynamics
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start11 Feb 2025
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer Non-resectableStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Medical Research Radiological Centre of the Ministry of Health of Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petrosian Artur, National Medical Research Radiological Centre of the Ministry of Health of Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898683
- Sponsor's protocol ID
- MRRC-Y90-PANC-P1
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results reported in the publication, including baseline characteristics, safety outcomes, dosimetry data, and tumour response assessments. Data will be available upon reasonable request to the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Intra-Arterial Yttrium-90 Radioembolization for the Treatment of Unresectable Pancreatic Adenocarcinoma: A Phase I Clinical Trial
- ClinicalTrials.gov ID
- NCT07898683
- Acronym / sponsor ID
- MRRC-Y90-PANC-P1
- Conditions
- Pancreatic Cancer Non-resectable
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- National Medical Research Radiological Centre of the Ministry of Health of RussiaUniversity, hospital or other
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transarterial RadioembolizationSelective 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. | Other | – |
Primary outcome
Safety and tolerability
Time frame: 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
Time frame: 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
Time frame: 8 weeks
Changes in tumour size per RECIST 1.1 criteria Metabolic response via FDG-PET/CT CA 19-9 biomarker dynamics
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the results reported in the publication, including baseline characteristics, safety outcomes, dosimetry data, and tumour response assessments. Data will be available upon reasonable request to the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Transarterial Radioembolization in people with Pancreatic Cancer Non-resectable, run by National Medical Research Radiological Centre of the Ministry of Health of Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Artur Petrosian (+79533162464, 79533162464@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: Perioperatively, up to 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.