None listed
Conditions
Brief summary
Myocardial involvement by sarcoid is a rare, but life-threatening manifestation of the disease. Current major criteria for diagnosis include cardiac magnetic resonance imaging to detect scarring and [18F]FDG PET/CT to detect inflammation. [18F]FDG PET/CT for cardiac sarcoidosis is complex, involves arduous preparation for the patient and can carry extra risks and the results of may be inconclusive. [68Ga]FAPI (fibroblast activating protein inhibitor) is a new agent developed for cancer imaging at PET/CT, but has been shown to detect other conditions including heart disease. Siebermair et al (2021), reported increased cardiac uptake in oncology patients with a known history of myocardial infarction, coronary artery disease and left ventricular failure. If [68Ga]-FAPI PET/CT proves to be more sensitive and specific than [18F] FDG PET CT for diagnosing and quantifying the disease and monitoring response, it will also improve the ease of imaging and has a lower radiation burden. Although patients may not directly benefit from this pilot study, there may be significant benefit for future patients who require imaging for Sarcoid Heart disease.
Interventions
This Study is a Open label , non randomized prospective pilot.
We plan to conduct a prospective, observational, pilot study on 10 consecutively recruited patients with known cardiac sarcoidosis, on the basis of current accepted diagnostic criteria.
Eligible patients will be referred by their Cardiologist to the Mercy Radiology.
A member of the Research team will contact those patients to confirm eligibility and willingness to participate. Once patients have been recruited they will undergo a PE
This Study is a Open label , non randomized prospective pilot. We plan to conduct a prospective, observational, pilot study on 10 consecutively recruited patients with known cardiac sarcoidosis, on the basis of current accepted diagnostic criteria. Eligible patients will be referred by their Cardiologist to the Mercy Radiology. A member of the Research team will contact those patients to confirm eligibility and willingness to participate. Once patients have been recruited they will undergo a PET CT scan using [68Ga]Ga-FAPI. We will analyse: Patient screening rate (number of screened over time); enrolment rate (number of enrolled over time); screening failure (total number of enrolled/total number of screened); reasons for screening failure Retention rate (number of patients completing the study /number of patients enrolled) and reasons for discontinuing the study before completion. This information will determine feasibility for a larger multicentre trial We will also analyse: Number of patients with cardiac uptake at [68Ga]Ga-FAPI PET/CT deemed diagnostic by study criteria This information will determine if [68Ga]Ga-FAPI is a more effective agent in diagnosing cardiac sarcoidosis. Patients will receive 1 dose of [68Ga]Ga-FAPI before their PET scan. Average radiation dose of 260MBq. The Agent will be administered intravenously So far there is no known adverse effects of FAPI serious or otherwise The radiation exposure is considerably lower than imaging agents currently used Patients can expect a single visit to our PETCT department. The study visit will last approximately 2 hours
Sponsors
Mercy Radiology
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Patient age >= 18 years. • All patients deemed by the Auckland sarcoid multidisciplinary team to have newly diagnosed, confirmed cardiac sarcoid based on histopathological/clinical/imaging data and who have had a CMR and [18F]FDG PET/CT as part of their diagnostic work up. • Able to give informed consent • Willing to use effective contraceptive methods for the duration of the study 90 days after receiving the IMP
Exclusion criteria
• All pts in which the diagnosis could not be confirmed. • Pts with confirmed disease who have not had [18F]FDG PET CT or CMR • Patients who have started therapy for cardiac sarcoidosis. • Patients unable, or unwilling to consent • females of childbearing potential must have a negative pregnancy test on the day of treatment study initiation). Participants are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. • Breastfeeding mothers
Outcome results
None listed