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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Livia Kruger, M.D.

Open for enrollment

Contact information:

Alicia Meek

5074229699

meek.alicia@mayo.edu

More information

Publications

Publications are currently not available