Interstitial Lung Disease
Conditions
Brief summary
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.
Interventions
DRUG⁶⁸Ga-FAPI-46
Subjects will have 68Ga-FAPI-46 intravenously administered
DIAGNOSTIC_TESTPET/CT
Subjects will complete a PET/CT approximately 60-70 minutes after being given ⁶⁸Ga-FAPI-46
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of interstitial lung disease * Radiologic lung abnormalities on diagnostic CT chest * Anatomic imaging (clinical diagnostic CT chest) obtained within ≤ 180 days prior to the planned FAPI 46 imaging exam or within 14 days after the imaging exam. * Willingness and ability to provide informed consent
Exclusion criteria
* Pregnant as determined by a pregnancy test as per institutional guidelines for individuals of child-bearing potential * Declining to use effective contraceptive methods during the study (for individuals of child-producing potential) * Need for emergent surgery that would be delayed by participation * Bacterial, viral, or fungal infections requiring systemic therapy * Serious co-morbidities and serious nonmalignant disease (e.g., hydronephrosis, kidney failure, liver failure, or other conditions) that in the opinion of the investigator, physician of record and/or Sofie could compromise patient safety and/or protocol objectives. * No available chest CT radiological data * No clear diagnosis of ILD * Intolerability to perform the exam due to exuberant dyspnea or severely low pulmonary capacity. * Breastfeeding. Note: nursing parents are allowed if the potential participant commits to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of the \[68Ga\]FAPI-46 injection. * Known hypersensitivity to any excipients used in \[68Ga\]FAPI-46
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Standardized Uptake Value in Abnormal Lung Parenchyma | 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 |
| Maximum Standardized Uptake Value in Normal Lung Parenchyma | Approximately 1 hour post injection | Maximum standardized uptake value (SUVmax) will be measured on 68Ga-FAPI-46 PET/CT in normal lung parenchyma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specificity of 68Ga-FAPI-46 PET/CT for Detection of Interstitial Lung Disease | 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. |
| Sensitivity of 68Ga-FAPI-46 PET/CT for Detection of Interstitial Lung Disease | 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 |
| Accuracy of 68Ga-FAPI-46 PET/CT for Detection of Interstitial Lung Disease | 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. |
Countries
United States
Contacts
CONTACTAlicia Meek
PRINCIPAL_INVESTIGATORLivia F. Kruger, MD
Mayo Clinic
Outcome results
None listed