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Hydrogel could starve tumors by cutting off their blood supply
NCT ID NCT04523350
First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time
Summary
This study tests a new liquid gel called Instylla HES that is injected into blood vessels feeding hypervascular tumors (tumors with many blood vessels). The gel hardens to block blood flow, starving the tumor. Researchers compare it to standard embolization treatments in about 150 adults with liver, kidney, or other hypervascular tumors. The goal is to see if the gel works as well as standard care and has an acceptable safety profile.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Instylla Hydrogel Embolic System (a liquid gel that blocks blood vessels)
- What this could lead to
- If successful, this hydrogel could offer a simpler, more consistent way to cut off blood supply to tumors, potentially improving outcomes for people with liver, kidney, or other hypervascular cancers.
- What could go wrong
- This is a mid-stage trial with 150 participants, so results may not apply to everyone. The hydrogel is new, and there is a risk of serious side effects like unintended blockage or damage to nearby tissues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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150 people
The number who actually took part.
- Started
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Mar 2021
- Finished
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Nov 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female subjects age ≥ 22 years old 2. Subjects with confirmed finding of hypervascular tumor on CT and/or MRI for whom TAE or cTACE is medically indicated, including but not limited to: 1. Subjects with unresectable primary or metastatic hepatic cancer 2. Subjects with primary, metastatic or benign renal tumors 3. Subjects with bone metastases 4. Subjects with adrenal tumors 5. Subjects with other hypervascular tumors 3. Subjects with at least one target lesion that is well-delineated such that, in the Investigator's opinion, the lesion can be measured in at least one dimension as 1 cm or more, suitable for remeasurement, and demonstrating definitive arterial enhancement (Note: Pre-operative tumors do not need to meet this criterion.) 4. Subjects with at least one target vessel ≤ 5mm and Instylla HES can be delivered to the target vessel(s). 5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2 (PS 0-1 for metastatic disease) 6. Subject or authorized representative have been informed of the nature of the study and has provided written informed consent approved by the appropriate local Ethics Committee/Institutional Review Board and agrees to comply with all protocol specified follow-up appointments. 7. Expected life expectancy ≥ 6 months after Index embolization Exclusion Criteria: 1. Embolization for lesions other than hypervascular tumors such as arteriovenous malformations. 2. It is anticipated that not all target vessels requiring embolization during the index procedure can be embolized with either HES alone or the SOC embolization agent as assigned. 3. Undergoing radioembolization or DEB-TACE for Index Procedure 4. Undergoing a planned secondary procedure the same day as the Index Procedure 5. Requires TAE/cTACE for liver tumors via extrahepatic collateral artery(ies) 6. Prior radioembolization of the target tumor lesion/vascular bed within 30 days of the Index Procedure. 7. For subjects with HCC or undergoing embolization to the liver: Child-Pugh Class C or presence of complete portal vein thrombosis. 8. Tumor lesions \> 8 cm in diameter (in one direction) or \>50% tumor volume burden of the target organ 9. If subject was treated with Avastin, last dose is within 4 weeks of the planned procedure. 10. Known severe atheromatosis or vascular anatomy that precludes catheterization 11. Presence of bilioenteric anastomoses and/or prior biliary stenting/drainage or any violation of the biliary sphincter, including sphincterotomy for embolization of liver tumors 12. Target lesion supplied by the pulmonary artery, coronary artery, or cerebral or cerebellar artery (requiring embolization of these arteries) or the artery to be embolized has connections to these arteries via a collateral pathway 13. Known allergies (based on history) to PEG, ferrous compounds, tert Butyl Hydroperoxide, contrast media or procedural sedatives/anesthetics that is not amenable to pre-medication 14. Uncorrectable impaired clotting: Platelet count \<30,000/µL or International Normalized Ratio (INR) \> 1.5 15. Serum creatinine \> 2 mg/dL 16. Serum bilirubin level \> 3 mg/dL 17. Serum albumin \< 2.5 g/dL 18. Any contraindication to angiography or embolization protocol utilized at treating institution. 19. Pregnant or breast-feeding or females planning on becoming pregnant with the next 3 months (women of child-bearing potential must undergo a pregnancy test performed in accordance with local institutional requirements). 20. Other concurrent conditions including an ongoing adverse effect or complication of prior therapy or adverse drug reactions, that in the opinion of the Investigator or Clinical Events Committee, would be unlikely to receive clinical benefit from the study procedure or participation in the study may compromise subject safety or study objectives (including but not limited to ongoing acute infection, renal dysfunction, morbid obesity, severe cardiac disease). 21. Enrollment in a concurrent study in which the study treatment may confound the evaluation of the study device
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Boston Medical Center
Boston, Massachusetts, 02118, United States
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Central Arkansas Radiation Therapy Institute, Inc.
Little Rock, Arkansas, 72205, United States
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Charlotte Radiology
Charlotte, North Carolina, 28202, United States
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Memorial Health Services
Long Beach, California, 92708, United States
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Mount Sinai
Toronto, Ontario, M5G 1Z5, Canada
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New York and Presbyterian Hospital (Cornell/Weill Medical College)
New York, New York, 10065, United States
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Olive View-UCLA Education & Research Institute
Sylmar, California, 91342-1495, United States
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St. Elizabeth Healthcare
Edgewood, Kentucky, 41017, United States
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Summit Health
Florham Park, New Jersey, 07932, United States
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Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5, Canada
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Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
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UAB Hospital
Birmingham, Alabama, 35233, United States
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University of California, Irvine
Irvine, California, 92697- 7600, United States
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University of Pennsylvania
Philadelphia, Pennsylvania, 19104-6061, United States
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University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
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