Tilmanocept for Cardiac Sarcoidosis

Overseen By Shaheela Fnu

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Duke University

Must not be taking: Radiopharmaceuticals

Disqualifiers: Pregnancy, Renal insufficiency, Hepatic insufficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a special imaging technique called Tc 99m Tilmanocept SPECT/CT can detect cardiac sarcoidosis, a condition where clusters of inflammatory cells form in the heart. The goal is to assess the effectiveness of this imaging in identifying active inflammation in the heart. Suitable participants include those with cardiac sarcoidosis confirmed by recent PET scans or those with certain heart rhythm issues but without sarcoidosis.

As a Phase 2 trial, this research focuses on evaluating the imaging technique's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to advancements in diagnosing cardiac sarcoidosis.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot have received any investigational product within 30 days or any radiopharmaceutical within 7 days before the study drug is given.

What prior data suggests that this imaging technique is safe for identifying cardiac sarcoidosis?

Research has shown that Tc 99m Tilmanocept is generally safe for people. Previous studies used this imaging agent, and participants usually experienced only minor side effects. This study examines its potential to detect cardiac sarcoidosis, and the safety results so far are encouraging. As this trial is in phase 2, the treatment has already passed initial safety tests in earlier trials. Participants can expect the treatment to be fairly safe, but as with any medical study, some risks remain possible. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for cardiac sarcoidosis, which often involve corticosteroids and immunosuppressive therapies to reduce inflammation, Tc 99m Tilmanocept offers a novel approach by using a targeted imaging agent. This agent binds specifically to activated macrophages, the immune cells involved in inflammation, allowing for precise SPECT-CT imaging. Researchers are excited because this method could provide a clearer picture of disease activity and inflammation in the heart, potentially leading to more tailored and effective treatment plans. This imaging capability is a significant advancement as it could help monitor disease progression and response to therapy more accurately.

What evidence suggests that Tc 99m Tilmanocept SPECT/CT imaging is effective for identifying cardiac sarcoidosis?

Research has shown that Tc 99m Tilmanocept, which participants in this trial will receive, is a promising tool for identifying cardiac sarcoidosis. This condition occurs when groups of immune cells form in the heart, leading to inflammation. Tc 99m Tilmanocept targets these immune cells, visible through a special imaging technique called SPECT/CT. Studies have demonstrated that this imaging method effectively highlights inflamed areas. This suggests that Tc 99m Tilmanocept could aid in diagnosing cardiac sarcoidosis by making it easier to detect active inflammation in the heart. ^{1 2 6 7 8}

Who Is on the Research Team?

Ravi Karra, MD

Principal Investigator

Duke Health

Are You a Good Fit for This Trial?

This trial is for adults with cardiac sarcoidosis confirmed by MRI or PET-CT, and those without it but with non-ischemic cardiomyopathy. Participants must consent, women of childbearing age need a negative pregnancy test, and they shouldn't have severe health issues or allergies to dextran.

Inclusion Criteria

Cohort 1: Participant has provided written informed consent with HIPAA or equivalent authorization before the initiation of any study-related procedures

Cohort 1: Participant has had a prior cardiac MRI with delayed enhancement consistent with cardiac sarcoidosis as defined in the AHA Scientific Statement on the Diagnosis and Management of Cardiac Sarcoidosis (2024)

Cohort 2: Participant has provided written informed consent with HIPAA or equivalent authorization before the initiation of any study-related procedures

Exclusion Criteria

Participant is pregnant or lactating

Participant size or weight is not compatible with imaging per the investigator

Participant has severe, acute, or chronic medical conditions, psychiatric conditions, laboratory abnormalities that would impart excess risk associated with study participation or study drug administration

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo Tc 99m Tilmanocept SPECT/CT imaging to identify cardiac sarcoidosis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tc 99m Tilmanocept

Trial Overview The study tests if Tc 99m Tilmanocept SPECT/CT imaging can detect cardiac sarcoidosis. It involves two cohorts: one diagnosed with the condition and another where it's been ruled out.

How Is the Trial Designed?

Group I: Tc 99m Tilmanocept SPECT CT imaging Experimental Treatment 1 Intervention

Participants with known cardiac sarcoidosis and a cardiac positron emission tomography (PET) imaging study showing active inflammation in the past 14 days or participants with a cardiomyopathy for which sarcoidosis has been excluded will undergo Single Photon Emission Computed Tomography (SPECT-CT) imaging after administration of Tc 99m Tilmanocept intravenously.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Foundation for Sarcoidosis Research

Collaborator

Trials

5

Recruited

8,100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07159074

Repurposing Tilmanocept for Cardiac Sarcoidosis The purpose of this study is to see if Tc 99m Tilmanocept SPECT/CT imaging can be used to identify cardiac sarcoidosis. Official Title. Repurposing Tc 99m ...

2. withpower.com withpower.com/trial/phase-2-cardiac-sarcoidosis-8-2025-8c6a8

Tilmanocept for Cardiac Sarcoidosis · Info for Participants What is the purpose of this trial? The purpose of this study is to see if Tc 99m Tilmanocept SPECT/CT imaging can be used to identify cardiac sarcoidosis.

3. ctv.veeva.com ctv.veeva.com/study/repurposing-tilmanocept-for-cardiac-sarcoidosis

Repurposing Tilmanocept for Cardiac Sarcoidosis The purpose of this study is to see if Tc 99m Tilmanocept SPECT/CT imaging can be used to identify cardiac sarcoidosis.

4. reporter.nih.gov reporter.nih.gov/project-details/7339685

RePORT RePORTER In this study, we will demonstrate that cross-talk correction of simultaneous 201TI/99mTc imaging can be improved significantly in the projection data acquired ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1568997218301150

Positron emission tomography (PET) and single photon ... This review summarizes the development of macrophage targeted tracers in the last decade and the potential application of macrophage targeted tracers.

6. adisinsight.springer.com adisinsight.springer.com/trials/700386255

Repurposing Tc 99m Tilmanocept Imaging for Cardiac ... The purpose of this study is to see if Tc 99m Tilmanocept SPECT/CT imaging can be used to identify cardiac sarcoidosis.

7. htsyndication.com htsyndication.com/us-fed-news/article/clinical-trial%3A-repurposing-tilmanocept-for-cardiac-sarcoidosis/555756307

Repurposing Tilmanocept for Cardiac Sarcoidosis Brief Summary: The purpose of this study is to see if Tc 99m Tilmanocept SPECT/CT imaging can be used to identify cardiac sarcoidosis. Study ...

8. meddatax.com meddatax.com/clinical-trials/NCT07159074

Repurposing Tilmanocept for Cardiac Sarcoidosis The purpose of this study is to see if Tc 99m Tilmanocept SPECT/CT imaging can be used to identify cardiac sarcoidosis ... safety data for this ...