Angiotensin II for more effective radioembolization in liver cancer: the RADIANT study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitair Medisch Centrum Utrecht

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04], Diseases [C] - Digestive System Diseases [C06]

Trial duration

5 Jan 2026 → ongoing

Decision date (initial)

2025-08-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

The primary objective is to assess the difference in tumor-to-non-tumor ratio (TNR) after the injection of 90Y glass microspheres with AT-II infusion compared to the TNR after 99mTc-MAA injection without AT-II infusion (i.e., the TNR improvement factor).

Secondary objectives 2

1. Safety
2. Technical success

Conditions and MedDRA coding

Liver cancer (primary or secondary)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Patients diagnosed with primary or metastatic liver tumors (any histological type)
2. Liver tumors with a tumor diameter ≥ 2 cm
3. Age ≥ 18 years
4. Written informed consent
5. A clinical indication for radioembolization
6. Competent and able to provide own informed consent (no legally designated representative)

Exclusion criteria 14

1. Any serious comorbidity preventing the safe administration of AT-II. This includes uncontrolled hypertension or treatment with ≥3 antihypertensive drugs, arterial (cerebro-)vascular or venous thromboembolic event within the past 6 months
2. Any serious and/or chronic liver disease preventing the safe administration of radioembolization
3. Uncorrectable extrahepatic deposition of scout dose activity; activity in the falciform ligament, portal lymph nodes and gallbladder is accepted
4. Pregnancy or breastfeeding
5. Body weight over 150 kg (because of maximum table load)
6. Current use of angiotensin-converting enzyme inhibitors
7. Current use of angiotensin II receptor blockers (ARBs)
8. Known hypercoagulable state (i.e., thrombophilia)
9. History of severe peripheral vascular disease
10. Known hypersensitivity to the active substance in Giapreza: angiotensin II
11. Known hypersensitivty to any of the excipients in Giapreza: mannitol, sodium hydroxide or hydrochloric acid
12. Known severe allergy for intravenous contrast fluids
13. Participation to another investigational study which may compromise any endpoint of the study
14. Any other significant comorbidity or medical condition that may compromise the safety of radioembolization

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. TNR improvement factor: the TNR after AT-II infusion with subsequent direct 90Y microsphere injection as measured on 90Y PET/CT divided by the TNR after 99mTc-MAA without AT-II infusion as measured on SPECT/CT.

Secondary endpoints 2

1. Toxicity profile of combining 90Y radioembolization with AT-II infusion (graded according to CTCAE v5.0)
2. Technical success of AT-II infusion. Technical success is defined as the successful intra-arterial administration of AT-II (10 μg/min for 100 seconds) followed by immediate 90Y glass microsphere injection.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitair Medisch Centrum Utrecht

Sponsor organisation

Universitair Medisch Centrum Utrecht

Address

Heidelberglaan 100

City

Utrecht

Postcode

3584 CX

Country

Netherlands

Scientific contact point

Organisation

Universitair Medisch Centrum Utrecht

Contact name

Trialbureau Imaging

Public contact point

Organisation

Universitair Medisch Centrum Utrecht

Contact name

Principal Investigator

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications