Optimizing Y90 therapy for liver cancer treatment
Yttrium-90 Radiation Lobectomy: Dose Optimization and Prediction of FLR Hypertrophy to Enable Resection of HCC
This study is testing if a special Y90 treatment can help people with liver cancer grow more healthy liver tissue so they can have surgery to remove the cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northwestern University Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Jacksonville, Florida and 1 other locations) |
| Trial ID | NCT04390724 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with hepatocellular carcinoma (HCC) who are candidates for liver resection but have inadequate future liver remnant. Participants will be divided into two groups: the first will receive standard Y90 radioembolization treatment, while the second will receive an optimized Y90 dose based on findings from the first group. The aim is to determine the ideal Y90 dose that can increase the volume of the future liver remnant, making patients more eligible for liver resection. The study will involve blood draws and quantitative MRI assessments at specific time points to evaluate liver growth.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with HCC who have a future liver remnant of less than 40% and meet specific health criteria.
Not a fit: Patients with advanced liver disease or those who do not meet the inclusion criteria for liver resection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the eligibility of patients for liver resection by optimizing Y90 radioembolization treatment.
How similar studies have performed: Other studies have shown promising results with Y90 radioembolization in increasing liver volume, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. 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
2. Child-Pugh stage A
3. Future Liver Remnant (FLR) of \< 40%
4. ECOG Performance Status 0-1
5. Bilirubin ≤ 3.0 mg/dl- Treatment may proceed if the Bilirubin is elevated if the tumor may be isolated from a vascular standpoint
6. Creatinine ≤ 2.0 mg/dl
7. ANC ≥ 1.5 K/uL
8. Platelets \> 25 K/uL
9. Patient is willing participate in this study and has signed the consent
10. 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 Criteria:
1. 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)
2. 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
3. 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
4. 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)
5. 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
6. History of severe peripheral allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically
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Where this trial is running
Jacksonville, Florida and 1 other locations
- Mayo Clinic — Jacksonville, Florida, United States (Active_not_recruiting)
- Northwestern University — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Robert Lewandowski, MD — Northwestern University
- Study coordinator: Robert Lewandowski, MD
- Email: r-lewandowki@northwestern.edu
- Phone: 312-695-9121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.