A TheraSphere® Advanced Dosimetry Retrospective Global Study in HCC

NCT03295006 | Completed FDA Device

• 1 other identifier: BTG-007961
• Study Type: observational
• Target: 209
• Locations: 8 countries
• Sites: 14

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.

Conditions

Hepatocellular Carcinoma

Keywords

TheraSphere, hepatocellular carcinoma, dosimetry

Outcome Measures

Primary Outcomes (1)

• Alternative two-compartment TheraSphere dosimetry methodology

  Normal tissue absorbed dose using pre-procedural 99mTc MAA (Technetium-99m Macroaggregated albumin) SPECT (Single-photon emission computer tomography) or SPECT/CT (Single-photon emission computer tomography/Computer Tomography) imaging, to allow the mean absorbed normal tissue dose corresponding to a ≤15% probability of Common Toxicities Criteria for Adverse Events (CTCAE) grade 3 or higher hyperbilirubinemia (in the absence of disease progression) to be calculated.

  Baseline

Secondary Outcomes (13)

• Tumor dose

  Baseline

• Serious adverse events

  3 months

• Specific non-serious adverse events (AEs) assessed as related or potentially related to the dose of TheraSphere

  3 months

• Clinical laboratory assessments

  6 weeks and 3 months

• Objective response (OR) of the target lesion and non-target sesions

  3 months and 6 months

Other Outcomes (1)

• Normal tissue dose and tumor dose using post-procedural PET/CT Imaging

  baseline

Study Arms (1)

Previous Therasphere treatment

Patients who had received TheraSphere yttrium-90 microspheres

Device: TheraSphere

Interventions

TheraSphere DEVICE

Patients who had received TheraSphere

Previous Therasphere treatment

Eligibility Criteria

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

Study Population

Patients with up to 10 well-defined unilobar HCC tumors per lobe with at least one tumor ≥3 cm ± PVT.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Boston Scientific Corporation: lead
• Biocompatibles UK Ltd: collaborator

Study Sites (14)

Stanford University Medical Center

Stanford, California, 94305-5642, United States

Location

University of Florida College of Medicine

Gainesville, Florida, 32610-0374, United States

Location

Northwestern Memorial Hospital, Robert H Lurie Comprehensive Cancer Center

Chicago, Illinois, 60611-2927, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Washington University in St. Louis, School of Medicine

Saint Louis, Louisiana, 63110, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030-3722, United States

Location

Centre Eugene Marquis

Rennes, 44229, France

Location

Universitätsklinikum Essen

Essen, 45122, Germany

Location

Foundation IRCCS Istituto Nazionale Tumori

Milan, 20133, Italy

Location

Universitair Medisch Centrum Utrecht

Utrecht, 3509 GA, Netherlands

Location

King Faisal Hospital

Riyāḑ, 12713, Saudi Arabia

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

Location

Istanbul university Istanbul medical school

Fatih, 34093, Turkey (Türkiye)

Location

Florence Nightingale

Şişli, 34381, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 39331131 DERIVED

• 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.

  PMID: 37698645 DERIVED

• 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.

  PMID: 35394152 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Marnix Lam, MD, PhD

  Universitair Medisch Centrum Utrecht

  PRINCIPAL INVESTIGATOR

• Riad Salem, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Etienne Garin, MD

  Centre Eugène Marquis

  PRINCIPAL INVESTIGATOR

• Hugo de Jong, PhD

  Universitair Medisch Centrum Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: September 27, 2017
• Study Start: October 31, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 21, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); IT (1); SA (1); CH (1); TU (2); FR (1); US (6); NL (1)