Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BCLC Stage a Hepatocellular Carcinoma | BCLC Stage A Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| BCLC Stage B Hepatocellular Carcinoma | BCLC Stage B Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| BCLC Stage C Hepatocellular Carcinoma | BCLC Stage C Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-Fluoromisonidazole | Other | — | UNRESOLVED |
| Biopsy | Procedure | — | UNRESOLVED |
| Dynamic Contrast-Enhanced Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (18F-fluoromisonidazole, PET, DCE MRI)
- description
- 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.
- interventionNames
- Other: 18F-Fluoromisonidazole
- Procedure: Biopsy
- Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
- Procedure: Positron Emission Tomography
Primary outcomes (2)
- measure
- To investigate the variability of hypoxia in HCC at baseline as quantified by BOLD MRI
- timeFrame
- From weeks 1-2 up to 1 year
- description
- Threshold \<1.0 R2 tumor to normal ratio (no unit) as a cutoff for hypoxia
- measure
- To investigate the variability of hypoxia in HCC at baseline as quantified by immunohistochemistry
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available