Low Dose Y90 Microspheres for the Planning of Radioembolization Therapy in Patients with Stage A-C Liver Cancer
Liver Cancer / Hepatoblastoma
18 Years and older, Male and Female
This phase II trial studies the side effects and how accurate low dose Y90 microspheres works for determining the amount of blood that flows between the liver and the lungs for the purpose of radioembolization (Y90) therapy planning in patients with stage A-C liver cancer. Y90 microspheres are tiny beads filled with a radioactive agent called Y90 that are placed inside the blood vessel that provides blood supply to the tumor. Understanding the amount of blood flow can help researchers obtain an accurate estimation of Y90 radioembolization therapy in the tumor(s), liver and lungs. This is to ensure maximizing tumor response while minimizing the side effects to the normal liver and lungs.
I. To compare the safety and accuracy/efficacy of low dose yttrium Y 90 (Y90) resin microspheres and macroaggregated albumin (MAA) in predicting the actual dose delivered to the tumor, liver, and lung after Y90 therapy.
I. To identify tumor dose response thresholds (TDRT) and tumor dose distribution in patients with hepatocellular carcinoma (HCC) treated with Y90 resin microspheres.
II. To optimize low dose Y90 techniques in predicting tumor to normal liver activity ration (TNR) and lung shunt fraction (LSF).
Patients undergo planning and mapping over 1 week. Patients receive low dose Y90 intra-arterially mapping and then receive therapeutic dose of Y90 intra-arterially for yttrium-90 microsphere radioembolization. Patients also undergo single photon emission computed tomography (SPECT)/computed tomography (CT) on the day of the mapping and 2 positron emission tomography (PET)/CT scans over 30 minutes either on the same day or the day after the planning and therapy respectively. Patients may undergo a second yttrium-90 microsphere radioembolization in 4 weeks if entire tumor is covered by the initial Y90 radioembolization therapy.
After completion of study treatment, patients are followed up at 1, 3, and 6 months and then every 3 months thereafter.
- Life expectancy of 6 months or more as determined by the investigator
- HCC confirmed by Liver Reporting & Data System (LIRADS) on magnetic resonance imaging (MRI) or CT
- Must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with CT scan, MRI, or calipers by clinical exam
- =< 3 lesions
- Longest dimension of the largest lesion =< 7 cm
- Single lobe disease
- Barcelona Clinic Liver Cancer stage A, B or C
- Eastern Cooperative Oncology Group (ECOG) < 2
- Lesion(s) < 50% of liver volume
- Bilirubin =< 2 mg/dL
- Albumin >= 3 g/dL
- Prothrombin time (PT)/international normalized rate (INR) < 2
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 institutional upper limit of normal (ULN)
- Platelet count > 50,000/mcL
- Lung shunt fraction of < 20% by planar MAA if dose modification results in inadequate dose delivered to the tumor(s)
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- Completion of all previous therapy (including surgery, radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of cancer >= 12 week before the start of study therapy
- Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions
- Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation
- The effects of Y90 microspheres 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. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of (investigational new drug application [IND] agent) administration. 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
Treatment Sites in Georgia
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