Optimizing Y90 Therapy for Radiation Lobectomy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNorthwestern University
About this trial
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. There will be 2 Patient Groups. The first group of patients will be treated with Y90 dose and embolic load as per standard-of-care. The second group of patients will be treated with the optimal Y90 dose and embolic load found in Patient Group 1.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patient must not be pregnant
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)
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
Trial population
Patients 18 years and older with HCC who are eligible to receive standard-of-care Y90 radioembolization and are hepatic resection candidates with inadequate future liver remnant
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Y90 radioembolization
DevicePatients with HCC who are eligible to receive standard-of-care Y90 radioembolization and are hepatic resection candidates with inadequate future liver remnant
Treatment groups
104 Participants
are divided into 2 treatment groupsGroup A: Patient Group 1: Y90 Standard-of-Care1 intervention
Group B: Patient Group 2: Y90 Dose determined by results from Group 11 intervention
Trial outcomes
Primary outcomes
1
Patient Group 1: Y90 Glass Microspheres
Measure the distribution of Y90 glass microspheres throughout the tumor and non-tumor hepatic parenchyma, as assessed by same day post-radioembolization study-specific non-FDG PET/CT scan.
Time frame
2 years2
Patient Group 1: Sphere distribution
Sphere distribution will be correlated with mean lobar absorbed radiation dose, embolic load, and time taken to achieve adequate Future Liver Remnant (\>40% of total liver volume) to determine optimal lobar dose and embolic load.
Time frame
2 years3
Patient Group 2: Quantitative Imaging Radiologic Biomarkers
Quantitative MRIs and biomarkers drawn will assess the association of circulating and imaging biomarkers on Future Liver Remnant hypertrophy. Tropic factor biomarkers to be drawn include: hepatocyte growth factor, epidermal growth factor, transforming growth factor beta, interleukin-6, tumor necrosis factor alpha, insulin-like growth factor binding protein, vascular endothelial growth factor, platelet derived growth factor, and phosphorus level.
Time frame
3 years4
Patient Group 2: HCC Resection
Assess progression-free survival between patients with HCC who underwent resection following Y90 radioembolization and those who presented with an adequate Future Liver Remnant for resection (i.e. who were not treated pre-surgically).
Time frame
3 yearsSponsors and contacts
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Northwestern University
Lead sponsor
Mayo Clinic
Collaborator
Source ClinicalTrials.gov