Low-dose Y90 Treatment Planning for HCC

NCT04172714 | Completed Results DMC FDA Device

• 1 other identifier: IRB00112192
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

The study proposes low-dose Y90 microspheres for therapy planning of HCC, as an alternative to Technetium (99mTc) albumin aggregated (MAA), to be a bioidentical therapeutic Y90 surrogate marker to better predict and thus achieve optimal therapeutic dosing.

Conditions

HCC; Cancer of Liver; Cancer

Keywords

Cancer; Radiation therapy; Liver Diseases; Radiology, Interventional; Radiology

Outcome Measures

Primary Outcomes (2)

• Lung Shunt Fraction (LSF) Ratio

  Y-90 radioembolization treatment requires estimating the activity shunted from the liver to the lungs, referred to as a lung shunt fraction (LSF). It is expressed in ratios, with higher ratio meaning a higher transit of Y-90 to the lungs (worse outcome) and lower ratio, lower transit of Y-90 to the lungs (better outcome).

  Baseline

• Tumor to Normal Liver Activity Ratio (TNR)

  The ratios of the tumor-to-normal liver parenchymal radioactivity uptake count will be measured. TNR values will be calculated by dividing the mean count of the tumorous volume of interest (VOI) by the mean count of normal liver.

  Baseline

Secondary Outcomes (1)

• Number of Participants With Tumor Response Using Imaging Modified Response Criteria in Solid Tumors (m-RECIST) Post Y90 Embolization

  6 months post intervention

Study Arms (1)

Second mapping with low-dose Y90

EXPERIMENTAL

Patients will undergo standard of care mapping study with 99TC-MAA to plan for Y90 radioembolization therapy. Additionally,non-standard of care, intervention will be to do a second mapping study using SIR-spheres microspheres with low-dose Y90 (15 mCi) before the therapeutic Y90 radioembolization.

Device: SIR-Spheres microspheres

Interventions

SIR-Spheres microspheres DEVICE

SIR-Spheres® Y-90 resin microspheres consist of biocompatible polymer resin microspheres of a median diameter of 32.5 microns (range between 20 and 60 microns) loaded with yttrium-90 (beta radiation penetrating an average of 2.5 mm in tissue to destroy tumor cells). The resin microspheres are small enough to become lodged in the arterioles within the growing rim of the tumor but are too large to pass through the capillaries and into the venous system. Since yttrium-90 has a half-life of 64.1 hours, most of the radiation (94%) is delivered to the tumor over 11 days.

Also known as: SIRSPHERE, Y90 resin-based microspheres

Second mapping with low-dose Y90

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥ 18 years
• Life expectancy of 6 months or more as determined by the investigator
• HCC confirmed by Liver Reporting \& Data System (LIRADS) on MRI or CT
• Must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) with CT scan, MRI, or calipers by clinical exam. See Section 12 (Measurement of Effect) for the evaluation of measurable disease.
• ≤3 lesions
• Longest dimension of the largest lesion ≤7cm
• Single lobe disease
• No significant extrahepatic metastatic disease
• Barcelona Clinic Liver Cancer Stage A, B or C
• ECOG \< 2 (Appendix A)
• Lesion(s) \<50% of liver volume
• Bilirubin ≤ 2 mg/dL
• Albumin ≥ 3 g/dL
• PT/INR \< 2
• AST/ALT ≤ 3 institutional upper limit of normal (ULN)

Sponsors & Collaborators

• Emory University: lead

Study Sites (3)

Emory University Midtown

Atlanta, Georgia, 30308, United States

Location

Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Related Publications (3)

• Kokabi N, Webster LA, Dabbous H, Shah A, Brandon D, Galt J, Xing M, Villalobos A, Davarpanahfakhr A, Kappadath SC, Schuster DM. Resin-Based 90 Y Tumor Dose as a Predictor of Duration of Response and Survival in Patients With Surgically Unresectable Hepatocellular Carcinoma : A Prospective Single-Arm Study. Clin Nucl Med. 2024 Sep 1;49(9):799-805. doi: 10.1097/RLU.0000000000005198. Epub 2024 May 21.

  PMID: 38861361 DERIVED

• Kokabi N, Arndt-Webster L, Chen B, Brandon D, Sethi I, Davarpanahfakhr A, Galt J, Elsayed M, Bercu Z, Cristescu M, Kappadath SC, Schuster DM. Voxel-based dosimetry predicting treatment response and related toxicity in HCC patients treated with resin-based Y90 radioembolization: a prospective, single-arm study. Eur J Nucl Med Mol Imaging. 2023 May;50(6):1743-1752. doi: 10.1007/s00259-023-06111-9. Epub 2023 Jan 18.

  PMID: 36650357 DERIVED

• Kokabi N, Webster LA, Elsayed M, Switchenko JM, Chen B, Brandon D, Galt J, Sethi I, Cristescu M, Kappadath SC, Schuster DM. Accuracy and Safety of Scout Dose Resin Yttrium-90 Microspheres for Radioembolization Therapy Treatment Planning: A Prospective Single-Arm Clinical Trial. J Vasc Interv Radiol. 2022 Dec;33(12):1578-1587.e5. doi: 10.1016/j.jvir.2022.08.027. Epub 2022 Sep 6.

  PMID: 36075560 DERIVED

MeSH Terms

Conditions

Liver Neoplasms; Neoplasms; Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases

Results Point of Contact

• Title: Nima Kokabi, MD
• Organization: Emory University

nima.kokabi@emory.edu

(404) 778-4747

Study Officials

• Nima Kokabi, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 21, 2019
• Study Start: December 16, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: December 6, 2022
• Results First Posted: December 6, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)