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SIR-Spheres Study to Calculate the Radiation-Absorbed Dose of 99mTc-MAA (MAApping)

Primary Purpose

Carcinoma, Carcinoma, Hepatocellular, Liver Neoplasm

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
99mTc-Macro Albumin Aggregate
Sponsored by
Sirtex Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Carcinoma focused on measuring Technetium-99m macroaggregated-albumin (99mTc-MAA), SIR-Spheres Y90 resin microspheres treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: Patients who are contraindicated for SIR-Spheres treatment Patients who are contraindicated for 99mTc-MAA per the manufacturer's package insert

Sites / Locations

  • Inland Imaging

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

99mTc-MAA Injection

Arm Description

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.

Outcomes

Primary Outcome Measures

Mean absorbed dose (Gy) for the whole body
Mean absorbed dose (Gy) for critical non-liver organs
Mean activity (Bq) for the whole body
Mean activity (Bq) for critical non-liver organs
Effective dose (Gy) for the whole body

Secondary Outcome Measures

Full Information

First Posted
April 21, 2023
Last Updated
July 25, 2023
Sponsor
Sirtex Medical
Collaborators
Bright Research Partners
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1. Study Identification

Unique Protocol Identification Number
NCT05848947
Brief Title
SIR-Spheres Study to Calculate the Radiation-Absorbed Dose of 99mTc-MAA
Acronym
MAApping
Official Title
Study to Calculate the Radiation-Absorbed Dose of Technetium-99m Macroaggregated Albumin (99mTc-MAA) to the Whole Body and Non-Liver Critical Organs
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 25, 2023 (Actual)
Primary Completion Date
July 5, 2023 (Actual)
Study Completion Date
July 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sirtex Medical
Collaborators
Bright Research Partners

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The investigation is a prospective, single center, open label, single-arm study. Patients enrolled in the study will have 3 imaging scans taken after 99mTc-MAA injection, the final of which will occur between 18 and 24 hours post-injection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Carcinoma, Hepatocellular, Liver Neoplasm
Keywords
Technetium-99m macroaggregated-albumin (99mTc-MAA), SIR-Spheres Y90 resin microspheres treatment

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
99mTc-MAA Injection
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
99mTc-Macro Albumin Aggregate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean absorbed dose (Gy) for the whole body
Time Frame
18-24 hours
Title
Mean absorbed dose (Gy) for critical non-liver organs
Time Frame
18-24 hours
Title
Mean activity (Bq) for the whole body
Time Frame
18-24 hours
Title
Mean activity (Bq) for critical non-liver organs
Time Frame
18-24 hours
Title
Effective dose (Gy) for the whole body
Time Frame
18-24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Patients who are contraindicated for SIR-Spheres treatment Patients who are contraindicated for 99mTc-MAA per the manufacturer's package insert
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Murrey, MD
Organizational Affiliation
Inland Imaging
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inland Imaging
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26089551
Citation
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.
Results Reference
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PubMed Identifier
35612924
Citation
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.
Results Reference
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PubMed Identifier
26434964
Citation
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.
Results Reference
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SIR-Spheres Study to Calculate the Radiation-Absorbed Dose of 99mTc-MAA

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