What side effects are associated with this type of intervention?

The most common side effects of Y90 Selective Internal Radiation Therapy (radioembolization with Y-90 beads) include fatigue, abdominal pain, nausea, and vomiting. Patients may also experience elevated liver enzymes, indicating liver stress or damage. Other liver-directed therapies, such as transarterial chemoembolization (TACE), can cause similar side effects along with an increased risk of gastroduodenal ulcers and elevated bilirubin levels. External beam radiation therapy (EBRT) may lead to skin irritation, fatigue, and gastrointestinal symptoms. These treatments aim to target the tumor while minimizing damage to healthy tissue, but they can still result in significant side effects that need to be managed under medical supervision.

What prior FDA approvals exist?

The FDA has approved several treatments for liver cancer, including radioembolization techniques similar to Y90 Selective Internal Radiation Therapy. One notable approval is for TheraSphere, a Yttrium-90 (Y-90) glass microsphere used for treating hepatocellular carcinoma (HCC). Additionally, the FDA has approved drugs like Sorafenib (Nexavar) and Lenvatinib (Lenvima) for advanced liver cancer, which are often used in combination with local therapies such as transarterial chemoembolization (TACE) and radioembolization. These treatments aim to block blood flow to the tumor and deliver targeted radiation or chemotherapy directly to the cancer cells.

What other types of research exist?

Promising alternatives to Y90 Selective Internal Radiation Therapy for liver cancer patients include: 1) Drug-eluting bead transarterial chemoembolization (DEB-TACE), which has shown enhanced efficacy and fewer complications compared to conventional TACE. 2) Proton beam therapy, particularly beneficial for patients with large tumors or portal vein thrombus, offering high local control rates. 3) Stereotactic body radiotherapy (SBRT), which provides precise, high-dose radiation to the tumor with minimal damage to surrounding tissues.

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Hypoxia Imaging Techniques for Liver Cancer

Q: What is the mechanism of action of this treatment?

Y90 Selective Internal Radiation Therapy (Radioembolization) involves injecting tiny beads filled with the radioactive isotope Yttrium-90 into the blood vessels supplying the liver tumor. These beads block the blood flow to the tumor, starving it of nutrients, while simultaneously delivering a high dose of localized radiation to kill cancer cells. This dual mechanism minimizes damage to surrounding healthy tissue. Other common treatments include Transarterial Chemoembolization (TACE), which combines chemotherapy with embolization to block blood flow and deliver drugs directly to the tumor, and External Beam Radiation Therapy (EBRT), which uses targeted radiation from outside the body. These treatments are crucial for liver cancer patients as they offer targeted approaches to shrink tumors, manage symptoms, and potentially improve survival rates, especially in cases where surgery is not an option.

Phase < 1

Recruiting

Led By Nima Kokabi, MD, FRCPC

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Oligometastatic disease

Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

Must not have

Previous liver-directed therapy to targeted tumors

Concurrent second malignancy outside of the liver

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from weeks 1-2 up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial evaluates using tiny radioactive beads to treat liver cancer that has spread to a few sites. The treatment involves placing these beads into the blood vessels feeding the tumor, blocking its blood supply and delivering targeted radiation. This approach aims to kill cancer cells while protecting healthy tissue.

Who is the study for?

This trial is for adults with liver cancer that has spread but not widely (oligometastatic). They should have at least one tumor larger than 3 cm, be in relatively good health (ECOG <=2), and have a life expectancy over 12 weeks. Women must test negative for pregnancy and all participants agree to use birth control. People with widespread liver cancer, poor liver function, or other serious health issues are excluded.

What is being tested?

The study tests if measuring low oxygen areas can predict outcomes of Y90 selective internal radiation therapy in oligometastatic liver cancer patients. It involves placing radioactive beads near the tumor to block blood flow and deliver high doses of radiation directly while sparing healthy tissue.

What are the potential side effects?

Potential side effects may include discomfort from the imaging procedures like MRI and PET scans, reactions from the biopsy procedure, as well as risks associated with radiation therapy such as fatigue, skin changes, abdominal pain or complications related to blocking blood vessels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has spread to a few other parts of my body.

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I can take care of myself but might not be able to do heavy physical work.

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My liver cancer is at an early to intermediate stage.

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I have a tumor that is at least 3 cm big.

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I am 18 years old or older.

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My liver cancer affects one or both lobes of my liver.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had treatments specifically aimed at liver tumors.

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I have another type of cancer besides the one in my liver.

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My liver tumor is spreading into nearby tissues.

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My liver cancer is in the most advanced stage.

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My liver is expected to receive more than 30 Gy of radiation in one session.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from weeks 1-2 up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from weeks 1-2 up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and from weeks 1-2 up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To investigate the variability of hypoxia in HCC at baseline as quantified by BOLD MRI

To investigate the variability of hypoxia in HCC at baseline as quantified by immunohistochemistry

Secondary study objectives

Determine whether hypoxia is predictor of response in HCC treated with Y90 SIRT

Treatment response

Side effects data

From 2015 Phase 2 trial • 59 Patients • NCT02150213

Renal Cyst

Adrenal Adenoma

Angiomyolipoma

Ovarian cyst

100%

80%

60%

40%

20%

Study treatment Arm

BGG492

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (18F-fluoromisonidazole, PET, DCE MRI)Experimental Treatment4 Interventions

Patients receive 18F-fluoromisonidazole IV and undergo PET and DCE MRI within 30 days before beginning Y90 SIRT. Patients undergo Y90 SIRT per standard of care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

2006

Completed Phase 2

~310

Positron Emission Tomography

2011

Completed Phase 2

~2200

Biopsy

2014

Completed Phase 4

~1090

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Y90 Selective Internal Radiation Therapy (Radioembolization) involves injecting tiny beads filled with the radioactive isotope Yttrium-90 into the blood vessels supplying the liver tumor. These beads block the blood flow to the tumor, starving it of nutrients, while simultaneously delivering a high dose of localized radiation to kill cancer cells. This dual mechanism minimizes damage to surrounding healthy tissue. Other common treatments include Transarterial Chemoembolization (TACE), which combines chemotherapy with embolization to block blood flow and deliver drugs directly to the tumor, and External Beam Radiation Therapy (EBRT), which uses targeted radiation from outside the body. These treatments are crucial for liver cancer patients as they offer targeted approaches to shrink tumors, manage symptoms, and potentially improve survival rates, especially in cases where surgery is not an option.