NCT07817563

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
55mo left

Started Oct 2026

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 16, 2026

Expected
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2030

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2031

Last Updated

September 18, 2026

Status Verified

September 1, 2026

Enrollment Period

3.5 years

First QC Date

September 8, 2026

Last Update Submit

September 15, 2026

Conditions

Interstitial Lung Disease

Outcome Measures

Primary Outcomes (2)

  • 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

    Approximately 1 hour post injection

  • 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

    Approximately 1 hour post injection

Secondary Outcomes (3)

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

    Baseline

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

    Baseline

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

    Baseline

Study Arms (1)

⁶⁸Ga-FAPI-46 PET/CT

EXPERIMENTAL

Subjects with interstitial lung disease will have a dose of 3 - 7 mCi (111 - 185MBq) of ⁶⁸Ga-FAPI-46 administered intravenously

Drug: ⁶⁸Ga-FAPI-46Diagnostic Test: PET/CT

Interventions

⁶⁸Ga-FAPI-46DRUG

Subjects will have 68Ga-FAPI-46 intravenously administered

⁶⁸Ga-FAPI-46 PET/CT
PET/CTDIAGNOSTIC_TEST

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

⁶⁸Ga-FAPI-46 PET/CT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission TomographyTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • Livia F. Kruger, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alicia Meek

CONTACT

507-422-9699meek.alicia@mayo.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 8, 2026

First Posted

September 14, 2026

Study Start (Estimated)

October 16, 2026

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

May 1, 2031

Last Updated

September 18, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)