RECRUITING

Optimizing Y90 Therapy for Radiation Lobectomy

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Conditions

HCCResectionTransplantMetastatic CancerAdult Primary Liver CancerY90 RadioembolizationLiver ResectionLiver TransplantLiver Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Yttrium-90 Radiation Lobectomy: Dose Optimization and Prediction of FLR Hypertrophy to Enable Resection of HCC

Quick Facts

Study Start:2020-07-17
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04390724

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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:
  2. * AFP \>200 and radiological evidence (arterial hypervascularity) of lesion \> 2 cm does not require biopsy
  3. * Two imaging modalities (triphasic CT, MRI, ultrasound, angiography) demonstrating arterial hypervascularity in the background of cirrhosis does not require biopsy
  4. * One imaging modality with a lesion with arterial hypervascularity with wash out in early or delayed venous phase, does not require a biopsy
  5. 2. Child-Pugh stage A
  6. 3. Future Liver Remnant (FLR) of \< 40%
  7. 4. ECOG Performance Status 0-1
  8. 5. Bilirubin ≤ 3.0 mg/dl- Treatment may proceed if the Bilirubin is elevated if the tumor may be isolated from a vascular standpoint
  9. 6. Creatinine ≤ 2.0 mg/dl
  10. 7. ANC ≥ 1.5 K/uL
  11. 8. Platelets \> 25 K/uL
  12. 9. Patient is willing participate in this study and has signed the consent
  13. 10. For Group 2 patients only:
  14. * 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
  1. 1. Patient must not be pregnant
  2. * Has not undergone a hysterectomy or bilateral oophorectomy
  3. * Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \> 12 months)
  4. 2. For Patients in Group 2 only:
  5. * Patients who have contraindications to MRI:
  6. * 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
  7. * Allergy to gadolinium-containing contrast media
  8. * Patients with a pacemaker, metallic clip, aneurysm clips, shrapnel fragments, etc.
  9. * Patients with an eGFR \< 30 mL/min/m²
  10. 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
  11. 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)
  12. 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
  13. 6. History of severe peripheral allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically

Contacts and Locations

Study Contact

Robert Lewandowski, MD
CONTACT
312-695-9121
r-lewandowki@northwestern.edu
Kristie Kennedy, MA
CONTACT
312-695-4023
kristie.kennedy@northwestern.edu

Principal Investigator

Robert Lewandowski, MD
PRINCIPAL_INVESTIGATOR
Northwestern University
Jeremy Collins, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Northwestern University
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Northwestern University

  • Robert Lewandowski, MD, PRINCIPAL_INVESTIGATOR, Northwestern University
  • Jeremy Collins, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-17
Study Completion Date2026-06

Study Record Updates

Study Start Date2020-07-17
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • HCC
  • Y90 Radioembolization
  • Liver Resection
  • Liver Transplant
  • Liver Cancer

Additional Relevant MeSH Terms

  • HCC
  • Resection
  • Transplant
  • Metastatic Cancer
  • Adult Primary Liver Cancer