Could a cancer imaging agent spot hidden heart inflammation?
NCT ID NCT07159074
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study is testing whether a radioactive tracer called Tc 99m tilmanocept, already used in other imaging, can help detect cardiac sarcoidosis—a condition where inflammation forms in the heart. Researchers will give the tracer to 15 adults with confirmed sarcoidosis and take special SPECT/CT pictures. They will compare these images to standard FDG-PET scans and MRI to see if the new method works as well or better.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tc 99m tilmanocept (a radioactive tracer used for imaging)
- What this could lead to
- If successful, this could provide a new, more accurate way to diagnose cardiac sarcoidosis without the need for fasting or special preparation.
- What could go wrong
- This is a small early-phase study with only 15 participants, so results may not apply to everyone. The imaging agent is being repurposed, and its effectiveness for this specific condition is unproven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Cohort 1: 1. The participant has provided written informed consent with HIPAA (Health Information Portability and Accountability Act) or equivalent authorization before the initiation of any study-related procedures. 2. Women of reproductive potential must have a negative urine pregnancy test at the time of the study. 3. The participant is at least 18 years of age. 4. The participant has a histological diagnosis sarcoidosis and meets 2014 HRS, 2014 WASOG, or 2016 JCS criteria for cardiac sarcoidosis. 5. The participant has had a clinically indicated cardiac PET-CT showing cardiac activity in the past 14 days. 6. The participant has had a prior cardiac MRI with delayed enhancement in pattern consistent with cardiac sarcoidosis as defined in the AHA Scientific Statement on the Diagnosis and Management of Cardiac Sarcoidosis (2024). Cohort 2: 1. The participant has provided written informed consent with HIPAA (Health Information Portability and Accountability Act) or equivalent authorization before the initiation of any study-related procedures. 2. Women of reproductive potential must have a negative urine pregnancy test at the time of the study. 3. The participant is at least 18 years of age. 4. Cardiac sarcoidosis has been clinically excluded. 5. The participant has an arrhythmogenic, non-ischemic cardiomyopathy defined as the presence of a cardiomyopathy with a history of recurrent (more than 1 episode) ventricular tachycardia, atrial arrhythmias, high grade AV block not due to ischemic heart disease Exclusion Criteria: 1. The participant is pregnant or lactating. 2. The participant size or weight is not compatible with imaging per the investigator. 3. The participant has renal insufficiency as demonstrated by a glomerular filtration rate of \< 30 mL/min. 4. The participant has hepatic insufficiency as demonstrated by ALT (alanine aminotransferase \[SGPT\]) or AST (aspartate aminotransferase \[SGOT\]) greater than 3 times the upper limit of normal. 5. The participant has any severe, acute, or chronic medical conditions and/or psychiatric conditions and/or laboratory abnormalities that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration that would deem the subject inappropriate for study participation. 6. The participant has a known allergy to or has had an adverse reaction to dextran exposure. 7. The participant has received an investigational product within 30 days prior to the Tc 99m tilmanocept administration (Day 0). 8. The participant has received any radiopharmaceutical within 7 days or 10 half-lives prior to the administration of Tc 99m tilmanocept (Day 0).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Duke University Hospital
RECRUITINGDurham, North Carolina, 27710, United States
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Other studies related to the condition(s) this trial covers.
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- Can a weekly injection calm heart inflammation in sarcoidosis?
- Major study aims to uncover hidden heart disease and test steroid treatment
- New PET tracer aims to reveal hidden immune activity in tumors and arteries
- Could a simple blood test replace heart scans for sarcoidosis?