← Back to Search

Hypoxia Imaging Techniques for Liver Cancer

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
Select...
My cancer has spread to a few other parts of my body.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
My liver cancer is at an early to intermediate stage.
Select...
I have a tumor that is at least 3 cm big.
Select...
I am 18 years old or older.
Select...
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:
Select...
I have had treatments specifically aimed at liver tumors.
Select...
I have another type of cancer besides the one in my liver.
Select...
My liver tumor is spreading into nearby tissues.
Select...
My liver cancer is in the most advanced stage.
Select...
My liver is expected to receive more than 30 Gy of radiation in one session.

Timeline

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
5%
Renal Cyst
5%
Adrenal Adenoma
2%
Ovarian cyst
2%
Angiomyolipoma
100%
80%
60%
40%
20%
0%
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
~1150

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.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,560 Total Patients Enrolled
104 Trials studying Liver Cancer
26,513 Patients Enrolled for Liver Cancer
Emory UniversityLead Sponsor
1,708 Previous Clinical Trials
2,607,464 Total Patients Enrolled
3 Trials studying Liver Cancer
438 Patients Enrolled for Liver Cancer
Nima Kokabi, MD, FRCPCPrincipal InvestigatorEmory University

Media Library

Biopsy Clinical Trial Eligibility Overview. Trial Name: NCT05250895 — Phase < 1
Liver Cancer Research Study Groups: Diagnostic (18F-fluoromisonidazole, PET, DCE MRI)
Liver Cancer Clinical Trial 2023: Biopsy Highlights & Side Effects. Trial Name: NCT05250895 — Phase < 1
Biopsy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05250895 — Phase < 1
~1 spots leftby Jan 2025