Status:
COMPLETED
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
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
BCLC Stage a Hepatocellular Carcinoma
BCLC Stage B Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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...
Detailed Description
PRIMARY OBJECTIVE: I. To investigate the variability of hypoxia in hepatocellular carcinoma (HCC) as quantified by blood oxygen level-dependent (BOLD) magnetic resonance imaging (MRI) and dynamic 18F...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2025
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT05250895
Start Date
April 28 2022
End Date
February 26 2025
Last Update
March 13 2025
Active Locations (1)
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1
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322