A Study to Evaluate Yttrium-90 Therapy for Radiation Lobectomy
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Jacksonville, Florida: 20-009201
NCT ID: NCT04390724
Sponsor Protocol Number: STU00209629
About this study
The Patient Group 1 primary objective is to measure the distribution of 90Y glass microspheres throughout the tumor and non-tumor hepatic parenchyma, as assessed by same day postradioembolization study-specific non-FDG PET/CT scan. Correlate this measurement with mean lobar absorbed radiation dose and embolic load given to patients and time taken to achieve adequate Future Liver Remnant (> 40% of total liver volume) to determine if there is an optimal lobar dose and embolic load.
The Patient Group 2 primary objectives are to assess the association of circulating and imaging biomarkers on Future Liver Remnant hypertrophy, and to assess progression-free survival between patients with HCC who underwent resection following Y-90 radioembolization with optimal dose and those who presented with an adequate Future Liver Remnant for resection (i.e., who were not treated pre-surgically).
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- Adults ≥ 18 years old of either gender.
- Patients must have been diagnosed with HCC confirmed by histology or must meet one of the following American Association for the Study of Liver Diseases (AASLD) guidelines:
- AFP > 200 and radiological evidence (arterial hypervascularity) of lesion > 2 cm does not require biopsy;
- Two imaging modalities (triphasic CT, MRI, ultrasound, angiography) demonstrating arterial hypervascularity in the background of cirrhosis does not require biopsy;
- One imaging modality with a lesion with arterial hypervascularity with wash out in early or delayed venous phase, does not require a biopsy.
- Child-Pugh stage A.
- Future Liver Remnant (FLR) of < 40%.
- ECOG Performance Status 0-1.
- Bilirubin < 3.0 mg/dl - treatment may proceed if the Bilirubin is elevated if the tumor may be isolated from a vascular standpoint.
- Creatinine < 2.0 mg/dl.
- ANC > 1.5 K/uL.
- Platelets > 25 K/uL.
- Patient is willing participate in this study and has signed consent the consent.
For Group 2 patients only:
- Patients planned 90Y dose and embolic load is found to fall within the optimal dose and embolic load size from data from Group 1 patients.
- Patient must not be pregnant, plan to get pregnant or breast-feeding. The effects of Y90, MRI and contrast agents on the developing human fetus are unknown. For this reason and because sedative agents (fentanyl and versed) used in this trial are not safe in pregnant women, women of child-bearing potential 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 female patient 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 and for the duration of study participation.
- NOTE: A FOCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy;
- Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months).
For Patients in Group 2 only:
- Patients who have contraindications to MRI:
- Patients that are claustrophobic and haven’t been able to tolerate an MRI in the past. Patients with mild claustrophobia are eligible and have the option to take 1mg oral Lorazepam prior to the MRI, if needed;
- Allergy to gadolinium-containing contrast media;
- Patients with a pacemaker, metallic clip, aneurysm clips, shrapnel fragments, etc.
- Patients with an eGFR < 30 mL/min/m^2.
- Must not have any significant life-threatening extra-hepatic disease or lifethreatening secondary malignancies, including patients who are on dialysis, have unresolved diarrhea, have serious unresolved infections including patients who are known to be HIV positive or have acute HBV or HCV.
- Must not have any contraindications to angiography and selective visceral catheterization such as bleeding diathesis or coagulopathy that is not correctable by usual therapy of hemostatic agents (e.g., closure device).
- Must not have any co-morbid disease or condition that would place the patient at undue risk and preclude safe use of TheraSphere treatment, in the Investigator’s judgment.
- History of severe peripheral allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
|Mayo Clinic Location
Mayo Clinic principal investigator
Beau Toskich, M.D.
Open for enrollment
Kendra Brown M.P.H., CCRP
Publications are currently not available