Status:
RECRUITING
Optimizing Y90 Therapy for Radiation Lobectomy
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Mayo Clinic
Conditions:
HCC
Resection
Eligibility:
All Genders
18+ years
Brief Summary
HCC resection candidates with inadequate future liver remnant will be enrolled in this study. They will be treated with Y90 radioembolization to help grow the liver enough to undergo liver resection. ...
Detailed Description
In this study there will be 2 different patient groups 1 and 2 that will consist of 40 and 64 patients, respectively with hepatocellular carcinoma who are eligible for resection and to receive Y90 rad...
Eligibility Criteria
Inclusion
- 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 the consent
- For Group 2 patients only:
- Patients planned Y90 dose and embolic load is found to fall within the optimal dose and embolic load size from data from Group 1 patients
Exclusion
- Patient must not be pregnant
- 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/m²
- Must not have any significant life-threatening extra-hepatic disease or life- threatening 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
- \-
Key Trial Info
Start Date :
July 17 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT04390724
Start Date
July 17 2020
End Date
July 1 2026
Last Update
July 28 2025
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611