NCT05848947

Brief Summary

The goal of this interventional clinical trial is to evaluate the dose of radiation of Technetium-99m macroaggregated-albumin (99mTc-MAA) after an intra-arterial injection to the whole body and non-liver critical organs in patients who are undergoing evaluation for SIR-Spheres treatment for hepatocellular carcinoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2023

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

April 25, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 8, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2023

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

January 29, 2025

Completed
Last Updated

January 29, 2025

Status Verified

January 1, 2025

Enrollment Period

2 months

First QC Date

April 21, 2023

Results QC Date

January 8, 2025

Last Update Submit

January 8, 2025

Conditions

CarcinomaCarcinoma, HepatocellularLiver Neoplasm

Keywords

Technetium-99m macroaggregated-albumin (99mTc-MAA)SIR-Spheres Y90 resin microspheres treatment

Outcome Measures

Primary Outcomes (5)

  • Mean Absorbed Dose (Gy) for the Whole Body

    18-24 hours

  • Mean Absorbed Dose (Gy) for Critical Non-liver Organs

    18-24 hours

  • Mean Activity (Bq) for the Whole Body

    18-24 hours

  • Mean Activity (Bq) for Critical Non-liver Organs

    18-24 hours

  • Effective Dose (Gy) for the Whole Body

    18-24 hours

Study Arms (1)

99mTc-MAA Injection

OTHER

Patients enrolled in the study will have 3 imaging scans taken after 99mTc-MAA Injection with the final scan occurring 18-24 hours after injection.

Drug: 99mTc-Macro Albumin Aggregate

Interventions

99mTc-Macro Albumin AggregateDRUG

Technetium-99m macroaggregated-albumin consists of macroaggregated-albumin particles labeled with technetium-99m (99mTc), with a size between 10 and 90 microns in diameter. 99mTc is a gamma emitting radioactive isotope commonly used for diagnostic localization studies.

99mTc-MAA Injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing, able, and mentally competent to provide written informed consent
  • Age 18 or older at the time of consent
  • Patients who are being evaluated for SIR-Spheres treatment eligibility

You may not qualify if:

  • Patients who are contraindicated for SIR-Spheres treatment
  • Patients who are contraindicated for 99mTc-MAA per the manufacturer's package insert

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inland Imaging

Spokane, Washington, 99208, United States

Location

Related Publications (3)

  • Gates VL, Singh N, Lewandowski RJ, Spies S, Salem R. Intraarterial Hepatic SPECT/CT Imaging Using 99mTc-Macroaggregated Albumin in Preparation for Radioembolization. J Nucl Med. 2015 Aug;56(8):1157-62. doi: 10.2967/jnumed.114.153346. Epub 2015 Jun 18.

    PMID: 26089551BACKGROUND

  • Kappadath SC, Lopez BP. Organ-level internal dosimetry for intra-hepatic-arterial administration of 99m Tc-macroaggregated albumin. Med Phys. 2022 Aug;49(8):5504-5512. doi: 10.1002/mp.15726. Epub 2022 Jun 6.

    PMID: 35612924BACKGROUND

  • McCollough CH, Bushberg JT, Fletcher JG, Eckel LJ. Answers to Common Questions About the Use and Safety of CT Scans. Mayo Clin Proc. 2015 Oct;90(10):1380-92. doi: 10.1016/j.mayocp.2015.07.011.

    PMID: 26434964BACKGROUND

MeSH Terms

Conditions

CarcinomaCarcinoma, HepatocellularLiver Neoplasms

Interventions

Technetium Tc 99m Aggregated Albumin

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsAdenocarcinomaDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Organotechnetium CompoundsOrganometallic CompoundsOrganic ChemicalsAlbuminsProteinsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Janet Bell, Director, Clinical Research Operations
Organization
Sirtex Medical
jbell@sirtex.com
978-866-1798

Study Officials

  • Douglas Murrey, MD

    Inland Imaging

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2023

First Posted

May 8, 2023

Study Start

April 25, 2023

Primary Completion

July 5, 2023

Study Completion

July 5, 2023

Last Updated

January 29, 2025

Results First Posted

January 29, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)