Mayo Clinic
Rochester, Minnesota, 55905, United States
NCT Number: NCT07817563
The purpose of this research is to better understand the distribution of an investigational radioactive imaging agent called 68Ga-FAPI-46 in the lungs of people with interstitial lung disease (ILD) during a Positron Emission Tomography/Computed Tomography (PET/CT) scan.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 1
Rochester, Minnesota, 55905, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will have 68Ga-FAPI-46 intravenously administered
Subjects will complete a PET/CT approximately 60-70 minutes after being given ⁶⁸Ga-FAPI-46
Time frame: Approximately 1 hour post injection
Maximum standardized uptake value (SUVmax) will be measured on 68Ga-FAPI-46 PET/CT in areas of abnormal lung parenchyma suggestive of interstitial lung disease
Time frame: Approximately 1 hour post injection
Maximum standardized uptake value (SUVmax) will be measured on 68Ga-FAPI-46 PET/CT in normal lung parenchyma
Time frame: Baseline
Specificity will be calculated using diagnostic CT chest findings as the reference standard. Specificity is defined as the proportion of participants without CT evidence of interstitial lung disease that are identified as negative on 68Ga-FAPI-46 PET/CT.
Time frame: Baseline
Sensitivity will be calculated using diagnostic CT chest findings consistent with interstitial lung disease as the reference standard. Sensitivity is defined as the proportion of participants with CT evidence of interstitial lung disease that are identified as positive on 68Ga-FAPI-46 PET/CT
Time frame: Baseline
Accuracy will be calculated using diagnostic CT chest findings as the reference standard. Accuracy is defined as the proportion of true positive and true negative 68Ga-FAPI-46 PET/CT findings among all evaluated findings.
Contact information is provided by the study sponsor or research team.
Mayo Clinic
Other
A Phase I Single Center Study Evaluating 68GA-FAPI-46 PET/CT in Patients With Interstitial Lung Disease
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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