Cardiac SarcoidosisPhase 2NCT07159074
Repurposing Tilmanocept for Cardiac Sarcoidosis
A Phase 2 study testing Tc 99m tilmanocept in people with Cardiac Sarcoidosis, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to see if Tc 99m Tilmanocept SPECT/CT imaging can be used to identify cardiac sarcoidosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Sarcoidosis
- What is being tested?
- Tc 99m tilmanocept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2025to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- 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.
Show all 13Show fewer
- 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:
- 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 block not due to ischemic heart disease
Who cannot join
- 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 study participation or study drug administration that would deem the subject inappropriate for study participation.
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Hospital
Durham, North Carolina, 27710
Ravi Karra, MD
About this study
Official title: Repurposing Tc 99m Tilmanocept Imaging 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.
- Conditions
- Cardiac Sarcoidosis
- Being tested
- Tc 99m tilmanocept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tc 99m tilmanoceptDrug
150 mcg containing 10 mCi of Tc 99m tilmanocept will be administered through an IV route of injection. SPECT-CT imaging will then be performed.
Tc 99m tilmanoceptDrug
150 mcg containing 10 mCi of Tc 99m tilmanocept will be administered through a SC route of injection. SPECT-CT imaging will then be performed.
| Study group | Role | What they receive |
|---|---|---|
| Tc 99m Tilmanocept SPECT CT imaging (intravenously) | Experimental | 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 (IV). Receives: Drug: Tc 99m tilmanocept |
| Tc 99m Tilmanocept SPECT CT imaging (subcutaneously) | Experimental | 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 subcutaneously (SC). Receives: Drug: Tc 99m tilmanocept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the cardiac segments with tilmanocept uptake and the cardiac segments with fluorodeoxyglucose (FDG) uptake on cardiac PET-CT. For each imaging modality, a standard 17-segment cardiac model will be used.
Measured: At the time of the scan (Baseline)
Secondary outcomes (7)
Correlation between TUVmax from tilmanocept imaging and SUVmax from FDG-PET imaging.
Measured: At the time of the scan (Baseline)
Correlation between the cardiac segments with tilmanocept uptake and the cardiac segments with hyperenhancement on cardiac MRI. For each imaging modality, a standard 17-segment cardiac model will be used.
Measured: At the time of the scan (Baseline)
Correlation of extracardiac sites with tilmanocept uptake and FDG uptake attributed to sarcoidosis.
Measured: At the time of the scan (Baseline)
Difference in percentage of segments with tilmanocept uptake in cohort 1 compared to cohort 2
Measured: At the time of the scan (Baseline)
Adverse events, identified through clinical laboratory results (hematology, serum chemistry, vital signs).
Measured: 1 year
Difference in biodistribution measured by cardiac uptake relative to liver uptake
Measured: Baseline
Difference in biodistribution measured by uptake of the upper extremity musculature
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start17 Sep 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SarcoidosisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Sarcoidosis Research
- Responsible party
- Sponsor
- Investigators
- Ravi Karra, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159074
- Sponsor's protocol ID
- PRO00117849
- Status last verified
- Oct 2025
- First submitted
- 20 Aug 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repurposing Tc 99m Tilmanocept Imaging for Cardiac Sarcoidosis
- ClinicalTrials.gov ID
- NCT07159074
- Acronym / sponsor ID
- PRO00117849
- Conditions
- Cardiac Sarcoidosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Foundation for Sarcoidosis Research
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if Tc 99m Tilmanocept SPECT/CT imaging can be used to identify cardiac sarcoidosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tc 99m Tilmanocept SPECT CT imaging (intravenously) | Experimental | Drug: Tc 99m tilmanoceptParticipants 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 (IV). |
| Tc 99m Tilmanocept SPECT CT imaging (subcutaneously) | Experimental | Drug: Tc 99m tilmanoceptParticipants 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 subcutaneously (SC). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (8 listed)
- 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 study participation or study drug administration that would deem the subject inappropriate for study participation.
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 |
|---|---|---|
| Tc 99m tilmanocept150 mcg containing 10 mCi of Tc 99m tilmanocept will be administered through an IV route of injection. SPECT-CT imaging will then be performed. | Drug | Tc 99m Tilmanocept SPECT CT imaging (intravenously) |
| Tc 99m tilmanocept150 mcg containing 10 mCi of Tc 99m tilmanocept will be administered through a SC route of injection. SPECT-CT imaging will then be performed. | Drug | Tc 99m Tilmanocept SPECT CT imaging (subcutaneously) |
Primary outcome
Correlation between the cardiac segments with tilmanocept uptake and the cardiac segments with fluorodeoxyglucose (FDG) uptake on cardiac PET-CT. For each imaging modality, a standard 17-segment cardiac model will be used.
Time frame: At the time of the scan (Baseline)
7 secondary outcomes
Correlation between TUVmax from tilmanocept imaging and SUVmax from FDG-PET imaging.
Time frame: At the time of the scan (Baseline)
Correlation between the cardiac segments with tilmanocept uptake and the cardiac segments with hyperenhancement on cardiac MRI. For each imaging modality, a standard 17-segment cardiac model will be used.
Time frame: At the time of the scan (Baseline)
Correlation of extracardiac sites with tilmanocept uptake and FDG uptake attributed to sarcoidosis.
Time frame: At the time of the scan (Baseline)
Difference in percentage of segments with tilmanocept uptake in cohort 1 compared to cohort 2
Time frame: At the time of the scan (Baseline)
Adverse events, identified through clinical laboratory results (hematology, serum chemistry, vital signs).
Time frame: 1 year
Difference in biodistribution measured by cardiac uptake relative to liver uptake
Time frame: Baseline
Difference in biodistribution measured by uptake of the upper extremity musculature
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Cardiac Sarcoidosis
RecruitingObservational study
Cardiac Sarcoidosis Multi-Center Prospective Cohort
Cardiac Sarcoidosis
Recruiting
A Prospective Diagnostic Trial of Al[¹⁸F]F-NOTA-folate PET in Patients With Suspected Cardiac Sarcoidosis and Infective Endocarditis
Cardiac Sarcoidosis, Infective Endocarditis
RecruitingObservational study
Cardiomyopathies and Heart Muscle Diseases: Cardiac Imaging in the Evaluation of Myocardial Fibrosis Transition
Heart Failure With Preserved Ejection Fraction, Hypertrophic Cardiomyopathy
RecruitingPhase 2
Rilonacept in Subjects With Cardiac Sarcoidosis
Cardiac Sarcoidosis
RecruitingObservational study
Exosome-based Omic Signatures of Disease Activity in Cardiac Sarcoidosis (EXODACS)
Cardiac Sarcoidosis, Sarcoidosis of the Heart
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.
Ravi Karra, MD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tc 99m tilmanocept in people with Cardiac Sarcoidosis, run by Duke University 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 13 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 27 Mar 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shaheela Fnu (919-681-2723, ravi.karra@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the cardiac segments with tilmanocept uptake and the cardiac segments with fluorodeoxyglucose (FDG) uptake on cardiac PET-CT. For each imaging modality, a standard 17-segment cardiac model will be used. (time frame: At the time of the scan (Baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2026; AzTrials last refreshed its copy on 31 Oct 2026.