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Study Evaluating 68GA-FAPI-46 PET/CT in Patients With Interstitial Lung Disease

ConditionInterstitial Lung Disease
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • ⁶⁸Ga-FAPI-46

    Drug

    Subjects will have 68Ga-FAPI-46 intravenously administered

  • PET/CT

    Diagnostic test

    Subjects will complete a PET/CT approximately 60-70 minutes after being given ⁶⁸Ga-FAPI-46

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: ⁶⁸Ga-FAPI-46 PET/CTExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Maximum Standardized Uptake Value in Abnormal Lung Parenchyma

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
2

Maximum Standardized Uptake Value in Normal Lung Parenchyma

Maximum standardized uptake value (SUVmax) will be measured on 68Ga-FAPI-46 PET/CT in normal lung parenchyma

Time frame
Approximately 1 hour post injection

Secondary outcomes

1

Specificity of 68Ga-FAPI-46 PET/CT for Detection of Interstitial Lung Disease

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
2

Sensitivity of 68Ga-FAPI-46 PET/CT for Detection of Interstitial Lung Disease

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
3

Accuracy of 68Ga-FAPI-46 PET/CT for Detection of Interstitial Lung Disease

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.

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: