Low-dose Y90 Treatment Planning for HCC
Completed · Not applicable
Conditions studied: HCC, Cancer of Liver, Cancer
In brief
The study proposes low-dose Y90 microspheres for therapy planning of HCC, as an alternative to Technetium (99mTc) albumin aggregated (MAA), to be a bioidentical therapeutic Y90 surrogate marker to better predict and thus achieve optimal therapeutic dosing.
Key facts
- Study ID
- NCT04172714
- Run by
- Emory University
- People needed
- 30
- Starts
- 2019-12-16
- Expected to finish
- 2021-06-30
- Last updated by the study team
- 2022-12-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults ≥ 18 years
- Life expectancy of 6 months or more as determined by the investigator
- HCC confirmed by Liver Reporting \& Data System (LIRADS) on 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. See Section 12 (Measurement of Effect) for the evaluation of measurable disease.
- ≤3 lesions
- Longest dimension of the largest lesion ≤7cm
- Single lobe disease
- No significant extrahepatic metastatic disease
- Barcelona Clinic Liver Cancer Stage A, B or C
- ECOG < 2 (Appendix A)
- Lesion(s) <50% of liver volume
- Bilirubin ≤ 2 mg/dL
- Albumin ≥ 3 g/dL
- PT/INR < 2
- AST/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.
- u. 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. v. 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. Winship Protocol #: RAD4784 Version Date: Aug 22, 2019 20 \| P a g e w. 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 [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
You may not qualify if…
- An individual who does not meet all the inclusion criteria in section.
Where it is running
- Emory University Midtown — Atlanta, Georgia, United States
- Emory Clinic — Atlanta, Georgia, United States
- Emory University Hospital — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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