Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07817563

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

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Maximum Standardized Uptake Value in Abnormal Lung Parenchyma

    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

  2. Maximum Standardized Uptake Value in Normal Lung Parenchyma

    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

Secondary outcomes

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

    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.

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

    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

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alicia Meek

CONTACT

[email protected]

507-422-9699

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

A Phase I Single Center Study Evaluating 68GA-FAPI-46 PET/CT in Patients With Interstitial Lung Disease

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Sep 14, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.