A TheraSphere® Advanced Dosimetry Retrospective Global Study in HCC

NCT ID: NCT03295006

Last Updated: 2021-04-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 209 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2020-12-01

Brief Summary

This retrospective, multinational, single-arm study will be conducted in at least 8 sites. An interim analysis will be conducted with data from 100 patients with up to 10 well defined HCC tumor(s) and with at least one tumor ≥3 cm. Normal tissue absorbed dose using pre-procedural 99mTc MAA SPECT or SPECT/CT imaging will be measured to allow the mean absorbed normal tissue dose corresponding to a ≤15% probability of CTCAE grade 3 or higher hyperbilirubinemia (in the absence of disease progression) to be calculated. Total bilirubin will be recorded and graded according to CTCAE version 4.02. All dose-related SAEs at 3 months follow-up will be followed until resolution, death or lost-to-follow-up. AEs related to disease progression will not be considered related to TheraSphere.

Detailed Description

Recently published evidence indicates a correlation between yttrium-90 dose delivered to the tumor and normal tissue with safety and efficacy outcomes but there are no validated methods to consistently measure dose delivered to the tumor and normal tissue. In contrast to the standard clinical approach based on average dose to one target volume, this trial, sponsored by Biocompatibles UK, will explore an alternative two-compartment TheraSphere dosimetry methodology to calculate absorbed dose to tumor and normal tissue

Conditions

Hepatocellular Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Previous Therasphere treatment

Patients who had received TheraSphere yttrium-90 microspheres

TheraSphere

Intervention Type: DEVICE

Patients who had received TheraSphere

Interventions

TheraSphere

Patients who had received TheraSphere

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Up to 10 well defined unilobar/bilobar HCC tumor(s) per lobe with at least one tumor ≥3 cm ± PVT
• Liver dominant disease (limited extra-hepatic metastases in the lung and/or lymph nodes are permitted (up to 5 lesions in the lung, with each individual lesion ≤2cm; any number of lymph node lesions with each individual lesion ≤2 cm).
• Child Pugh stage A or B7.
• BCLC A, B or C.
• Must be male or female, 18 years of age or older.
• Bilirubin ≤2 mg/dL.
• Tumor replacement <50% of total liver volume assessed by diagnostic imaging consisting of multi-phase contrast enhanced CT or contrast enhanced MRI.
• Diagnostic imaging consisting of multi-phase contrast enhanced CT or contrast enhanced MRI within 3 months prior to TheraSphere® administration.
• Infusion of 99mTc-MAA in a single arterial location sufficient to cover up to 10 well-defined tumors per lobe ≤ 6 weeks prior to TheraSphere® administration.
• Patients must have received TheraSphere® in a single treatment setting in one or more arterial locations sufficient to cover up to 10 well-defined tumors based on angiography. Subsequent TheraSphere® treatment to the second lobe may occur at least 4 weeks following the initial TheraSphere® treatment.
• For patients receiving a second TheraSphere® treatment bilirubin levels must have been recorded prior to the second treatment
• Patients must have had clinical evaluation (assessment of liver specific AEs) and laboratory evaluation (at least a serum bilirubin level) at baseline.
• Tumor(s), ≥3 cm, measurable by mRECIST and RECIST 1.1 at baseline

Exclusion Criteria

• Prior external beam radiation treatment to the liver.
• Prior loco-regional liver directed therapy (cTACE, DEB-TACE and SIR-Spheres).
• Prior liver transplantation.
• Whole liver TheraSphere® treatment following prior liver resection.
• TheraSphere administration to ≤2 segments (e.g., radiation segmentectomy).
• Additional active therapy (TACE and treatment with SIR-Spheres) between first TheraSphere treatment and 3 month (90 days) imaging.
• Hepatic vein invasion.
• Diagnosis of disease progression at peri-procedural imaging as compared to the baseline imaging (physician's discretion).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biocompatibles UK Ltd

INDUSTRY

Sponsor Role: collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marnix Lam, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitair Medisch Centrum Utrecht

Riad Salem, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Etienne Garin, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Eugène Marquis

Hugo de Jong, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitair Medisch Centrum Utrecht

Locations

Stanford University Medical Center

Stanford, California, United States

University of Florida College of Medicine

Gainesville, Florida, United States

Northwestern Memorial Hospital, Robert H Lurie Comprehensive Cancer Center

Chicago, Illinois, United States

Indiana University School of Medicine

Indianapolis, Indiana, United States

Washington University in St. Louis, School of Medicine

Saint Louis, Louisiana, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Centre Eugene Marquis

Rennes, , France

Universitätsklinikum Essen

Essen, , Germany

Foundation IRCCS Istituto Nazionale Tumori

Milan, , Italy

Universitair Medisch Centrum Utrecht

Utrecht, , Netherlands

King Faisal Hospital

Riyāḑ, , Saudi Arabia

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Istanbul university Istanbul medical school

Fatih, , Turkey (Türkiye)

Florence Nightingale

Şişli, , Turkey (Türkiye)

Countries

United States; France; Germany; Italy; Netherlands; Saudi Arabia; Switzerland; Turkey (Türkiye)

References

Lam M, Garin E, Haste P, Denys A, Geller B, Kappadath SC, Turkmen C, Sze DY, Alsuhaibani HS, Herrmann K, Maccauro M, Cantasdemir M, Dreher M, Fowers KD, Gates V, Salem R. Utility of pre-procedural [99mTc]TcMAA SPECT/CT Multicompartment Dosimetry for Treatment Planning of 90Y Glass microspheres in patients with Hepatocellular Carcinoma: comparison of anatomic versus [99mTc]TcMAA-based Segmentation. Eur J Nucl Med Mol Imaging. 2025 Jan;52(2):744-755. doi: 10.1007/s00259-024-06920-6. Epub 2024 Sep 27.

Reference Type: DERIVED

PMID: 39331131 (View on PubMed)

Lam M, Garin E, Palard-Novello X, Mahvash A, Kappadath C, Haste P, Tann M, Herrmann K, Barbato F, Geller B, Schaefer N, Denys A, Dreher M, Fowers KD, Gates V, Salem R. Direct comparison and reproducibility of two segmentation methods for multicompartment dosimetry: round robin study on radioembolization treatment planning in hepatocellular carcinoma. Eur J Nucl Med Mol Imaging. 2023 Dec;51(1):245-257. doi: 10.1007/s00259-023-06416-9. Epub 2023 Sep 12.

Reference Type: DERIVED

PMID: 37698645 (View on PubMed)

Lam M, Garin E, Maccauro M, Kappadath SC, Sze DY, Turkmen C, Cantasdemir M, Haste P, Herrmann K, Alsuhaibani HS, Dreher M, Fowers KD, Salem R. A global evaluation of advanced dosimetry in transarterial radioembolization of hepatocellular carcinoma with Yttrium-90: the TARGET study. Eur J Nucl Med Mol Imaging. 2022 Aug;49(10):3340-3352. doi: 10.1007/s00259-022-05774-0. Epub 2022 Apr 8.

Reference Type: DERIVED

PMID: 35394152 (View on PubMed)

Other Identifiers

BTG-007961

Identifier Type: -

Identifier Source: org_study_id