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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%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from weeks 1-2 up to 1 year
Awards & highlights

Study Summary

This trial is testing whether hypoxia can help predict the success of Y90 radioembolization for patients with liver cancer that has spread to a few sites.

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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Determine whether hypoxia is predictor of response in HCC treated with Y90 SIRT
Treatment response

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
2008
Completed Phase 2
~2260
Biopsy
2014
Completed Phase 4
~840

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,327 Total Patients Enrolled
104 Trials studying Liver Cancer
26,668 Patients Enrolled for Liver Cancer
Emory UniversityLead Sponsor
1,634 Previous Clinical Trials
2,560,153 Total Patients Enrolled
4 Trials studying Liver Cancer
468 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers are taking part in this clinical research?

"Affirmative. According to information on clinicaltrials.gov, this medical trial is actively recruiting participants since it was first posted in April 28th 2022 and last updated in May 25th 2022. A total of 20 patients are needed for the study at a single site."

Answered by AI

Are there any available positions within this research study for participants?

"Affirmative. According to clinicaltrials.gov, this research initiative, which has been active since April 28th 2022, is actively recruiting patients. Currently they are looking for 20 individuals from a single medical site to take part in the study."

Answered by AI
~7 spots leftby Mar 2025