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New treatment option for Cardiac Sarcoidosis
Official title Repurposing Tilmanocept for Cardiac Sarcoidosis
ClinicalTrials.gov ID: NCT07159074
What this study is testing
What is Tc 99m tilmanocept?
Tc 99m tilmanocept is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cardiac sarcoidosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to see if Tc 99m Tilmanocept SPECT/CT imaging can be used to identify cardiac sarcoidosis.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Cohort 1:
- The participant has provided written informed consent with HIPAA (Health Information Portability and Accountability Act) or equivalent authorization...
- Women of reproductive potential must have a negative urine pregnancy test at the time of the study.
- The participant is at least 18 years of age.
- The participant has a histological diagnosis sarcoidosis and meets 2014 HRS, 2014 WASOG, or 2016 JCS criteria for cardiac sarcoidosis.
You likely can't join if
- The participant is pregnant or lactating.
- The participant size or weight is not compatible with imaging per the investigator.
- The participant has renal insufficiency as demonstrated by a glomerular filtration rate of \< 30 mL/min.
- The participant has hepatic insufficiency as demonstrated by ALT (alanine aminotransferase [SGPT]) or AST (aspartate aminotransferase [SGOT]) greater...
- The participant has any severe, acute, or chronic medical conditions and/or psychiatric conditions and/or laboratory abnormalities that would impart...
- The participant has a known allergy to or has had an adverse reaction to dextran exposure.
See the full eligibility criteria
- Cohort 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.
- Women of reproductive potential must have a negative urine pregnancy test at the time of the study.
- The participant is at least 18 years of age.
- The participant has a histological diagnosis sarcoidosis and meets 2014 HRS, 2014 WASOG, or 2016 JCS criteria for cardiac sarcoidosis.
- The participant has had a clinically indicated cardiac PET-CT showing cardiac activity in the past 14 days.
- 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...
- 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.
- Women of reproductive potential must have a negative urine pregnancy test at the time of the study.
- The participant is at least 18 years of age.
- Cardiac sarcoidosis has been clinically excluded.
- 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...
- The participant is pregnant or lactating.
- The participant size or weight is not compatible with imaging per the investigator.
- The participant has renal insufficiency as demonstrated by a glomerular filtration rate of \< 30 mL/min.
- 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.
- 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...
- The participant has a known allergy to or has had an adverse reaction to dextran exposure.
- The participant has received an investigational product within 30 days prior to the Tc 99m tilmanocept administration (Day 0).
- The participant has received any radiopharmaceutical within 7 days or 10 half-lives prior to the administration of Tc 99m tilmanocept (Day 0).
The study team makes the final eligibility decision.
Where it's taking place
- Durham, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Durham, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.