CarcinomaPhase 4MAAppingNCT05848947

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

A Phase 4 study testing 99mTc-Macro Albumin Aggregate in people with Carcinoma and Carcinoma, Hepatocellular, run by Sirtex Medical at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Carcinoma, Carcinoma, Hepatocellular, Liver Neoplasm
What is being tested?: 99mTc-Macro Albumin Aggregate
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteUnited States
Study dates: 25 Apr 2023to 5 Jul 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Inland Imaging
Spokane, Washington, 99208

Other trials in United States

About this study

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

Read the 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.

Conditions: Carcinoma, Carcinoma, Hepatocellular, Liver Neoplasm
Being tested: 99mTc-Macro Albumin Aggregate
Keywords: Technetium-99m macroaggregated-albumin (99mTc-MAA), SIR-Spheres Y90 resin microspheres treatment
Medical subject headings: Carcinoma, Carcinoma, Hepatocellular, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT05848947
Study group	Role	What they receive
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. Receives: Drug: 99mTc-Macro Albumin Aggregate

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Absorbed Dose (Gy) for the Whole Body
Measured: 18-24 hours
Mean Absorbed Dose (Gy) for Critical Non-liver Organs
Measured: 18-24 hours
Mean Activity (Bq) for the Whole Body
Measured: 18-24 hours
Mean Activity (Bq) for Critical Non-liver Organs
Measured: 18-24 hours
Effective Dose (Gy) for the Whole Body
Measured: 18-24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Apr 20235 Jul 2023

First posted8 May 2023
Study start25 Apr 2023
Primary completion5 Jul 2023
Study completion5 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for CarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05848947
Sponsor's protocol ID: STX2301
Acronym: MAApping
Status last verified: Jan 2025
First submitted: 21 Apr 2023
Last updated: 29 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 26089551
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.
PubMed 35612924
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.
PubMed 26434964

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05848947
Acronym / sponsor ID: MAApping / STX2301
Conditions: Carcinoma, Carcinoma, Hepatocellular, Liver Neoplasm
Keywords: Technetium-99m macroaggregated-albumin (99mTc-MAA), SIR-Spheres Y90 resin microspheres treatment
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 5 participants (actual)
Lead sponsor: Sirtex MedicalIndustry (pharma, biotech, devices)
Collaborators: Bright Research Partners
Study start: 25 Apr 2023 (actual)
Primary completion: 5 Jul 2023 (actual)
Study completion: 5 Jul 2023 (actual)
First posted: 8 May 2023 (actual)
Results: Posted 29 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
99mTc-MAA Injection	Other	Drug: 99mTc-Macro Albumin AggregatePatients enrolled in the study will have 3 imaging scans taken after 99mTc-MAA Injection with the final scan occurring 18-24 hours after injection.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
99mTc-Macro Albumin AggregateTechnetium-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.	Drug	99mTc-MAA Injection

Primary outcome

Mean Absorbed Dose (Gy) for the Whole Body
Time frame: 18-24 hours
Mean Absorbed Dose (Gy) for Critical Non-liver Organs
Time frame: 18-24 hours
Mean Activity (Bq) for the Whole Body
Time frame: 18-24 hours
Mean Activity (Bq) for Critical Non-liver Organs
Time frame: 18-24 hours
Effective Dose (Gy) for the Whole Body
Time frame: 18-24 hours

Results and safety

Results posted to the registry on 29 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
99mTc-MAA Injection	5	5

Primary outcome: Mean Absorbed Dose (Gy) for the Whole Body

Time frame: 18-24 hours. Mean (Standard Deviation). Unit: mGy

Measure	99mTc-MAA Injection n = 5
Value	0.941 (0.926)

Primary outcome: Mean Absorbed Dose (Gy) for Critical Non-liver Organs

Time frame: 18-24 hours. Mean (Standard Deviation). Unit: mGy

Measure	99mTc-MAA Injection n = 5
Adrenal glands	1.415 (1.524)
Gallbladder	4.855 (5.444)
Heart	0.736 (0.692)
Kidney	2.073 (3.401)
Lungs	1.701 (1.869)
Pancreas	1.221 (0.990)
Spleen	0.784 (1.037)
Stomach	2.530 (2.634)

Primary outcome: Mean Activity (Bq) for the Whole Body

Time frame: 18-24 hours. Mean (Standard Deviation). Unit: GBq

Measure	99mTc-MAA Injection n = 5
Value	0.150 (0.014)

Primary outcome: Mean Activity (Bq) for Critical Non-liver Organs

Time frame: 18-24 hours. Mean (Standard Deviation). Unit: GBq

Measure	99mTc-MAA Injection n = 5
Adrenal glands	0.150 (0.014)
Gallbladder	0.148 (0.016)
Heart	0.150 (0.014)
Kidney	0.150 (0.014)
Lungs	0.150 (0.014)
Pancreas	0.150 (0.014)
Spleen	0.145 (0.018)
Stomach	0.150 (0.014)

Adverse events

Time frame: Adverse event data was collected from the procedure until 18-24 hours post-procedure.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
99mTc-MAA Injection	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26089551Gates 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.
Background: PubMed 35612924Kappadath 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.
Background: PubMed 26434964McCollough 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Douglas Murrey, MD principal investigator

Inland Imaging

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 99mTc-Macro Albumin Aggregate in people with Carcinoma and Carcinoma, Hepatocellular, run by Sirtex Medical at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Absorbed Dose (Gy) for the Whole Body (time frame: 18-24 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05848947, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.