BOLD MRI and FMISO PET for the Assessment of Hypoxic Tumor Microenvironment in Patients with Oligometastatic Liver Cancer Undergoing Yttirum-90 Selective Internal Radiation Therapy
Molecular Imaging of the Hypoxic Tumor Microenvironment to Predict Response to Yttirum-90 Selective Internal Radiation Therapy in Hepatocellular Carcinoma- Pilot Study
4 other identifiers
interventional
9
1 country
1
Brief Summary
This early phase I trial evaluates the use of hypoxia (lack of oxygen) as a measure in determining the outcome of Y90 selective internal radiation therapy in patients with liver cancer that has spread to a limited number of sites (oligometastatic). Radioembolization with Y90 is a minimally invasive procedure that combines embolization and radiation therapy to treat metastatic liver cancer. Tiny beads filled with radioactive isotope Y-90 are placed inside the blood vessel that provide blood supply to the tumor. This will block the blood flow to the tumor cells while providing a high radiation dose without harming healthy normal tissue.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Apr 2022
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2021
CompletedFirst Posted
Study publicly available on registry
February 22, 2022
CompletedStudy Start
First participant enrolled
April 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2025
CompletedMarch 13, 2025
March 1, 2025
2.8 years
December 22, 2021
March 11, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
To investigate the variability of hypoxia in HCC at baseline as quantified by BOLD MRI
Threshold \<1.0 R2 tumor to normal ratio (no unit) as a cutoff for hypoxia
From weeks 1-2 up to 1 year
To investigate the variability of hypoxia in HCC at baseline as quantified by immunohistochemistry
The staining intensity will be measured and scored with four scales: no staining=0, weak staining=1, moderate staining=2, and strong staining=3. The final staining score will be obtained by stained stumor area% x positive tumor cells % x staining intensity. The tumors will be then categorized as hypoxic (scores 8 to 16) vs. non-hypoxic (scores 0 to 7) (no units).
From weeks 1-2 up to 1 year
Secondary Outcomes (2)
Determine whether hypoxia is predictor of response in HCC treated with Y90 SIRT
From week 0 up to 1 year
Treatment response
From week 0 Up to 1 year
Study Arms (1)
Diagnostic (18F-fluoromisonidazole, PET, DCE MRI)
EXPERIMENTALPatients 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.
Interventions
Given IV
Undergo biopsy
Undergo DCE MRI
Undergo PET
Eligibility Criteria
You may qualify if:
- Age \>= 18 years
- Established HCC diagnosis, unilobar or bilobar disease
- At least 1 tumor \>= 3 cm
- Oligometastatic disease
- Barcelona Clinic Liver Cancer (BCLC) stage A, B or C
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
- Life expectancy \> 12 weeks as determined by the Investigator
- The effects of Y90 Radioembolization on the developing human fetus are unknown. For this reason, female of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy
- FCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months
You may not qualify if:
- Patients who are definite transplant candidates
- Concurrent second malignancy outside of the liver
- Infiltrative liver tumor
- Previous liver-directed therapy to targeted tumors
- BCLC stage D
- Bilirubin \> 2 mg/dL for lobar treatment and bilirubin \> 3 mg/dL for segmental or bi-segmental Y90-SIRT
- Albumin \< 3 g/dL
- Projected lung dose of \> 30 Gy in a single session to the liver after prospective treatment planning
- Body mass index (BMI) \> 40
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nima Kokabi, MD, FRCPC
Emory University
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 22, 2021
First Posted
February 22, 2022
Study Start
April 28, 2022
Primary Completion
February 26, 2025
Study Completion
February 26, 2025
Last Updated
March 13, 2025
Record last verified: 2025-03