Interstitial Lung DiseasePhase 1NCT07817563
Study Evaluating 68GA-FAPI-46 PET/CT in Patients With Interstitial Lung Disease
A Phase 1 study testing ⁶⁸Ga-FAPI-46 and PET/CT in people with Interstitial Lung Disease, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- ⁶⁸Ga-FAPI-46 and PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2026to May 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I Single Center 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.
- Conditions
- Interstitial Lung Disease
- Being tested
- ⁶⁸Ga-FAPI-46, PET/CT
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
⁶⁸Ga-FAPI-46Drug
Subjects will have 68Ga-FAPI-46 intravenously administered
PET/CTDiagnostic test
Subjects will complete a PET/CT approximately 60-70 minutes after being given ⁶⁸Ga-FAPI-46
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: ⁶⁸Ga-FAPI-46; Diagnostic Test: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Approximately 1 hour post injection
Secondary outcomes (3)
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.
Measured: Baseline
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
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start16 Oct 2026 (estimated)
- Primary completionMay 2030 (estimated)
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Livia Kruger, Mayo Clinic
- Investigators
- Livia F. Kruger, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817563
- Sponsor's protocol ID
- 25-009401
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Single Center Study Evaluating 68GA-FAPI-46 PET/CT in Patients With Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT07817563
- Acronym / sponsor ID
- 25-009401
- Conditions
- Interstitial Lung Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 16 Oct 2026 (estimated)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2031 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ⁶⁸Ga-FAPI-46 PET/CT | Experimental | Drug: ⁶⁸Ga-FAPI-46, Diagnostic Test: PET/CTSubjects with interstitial lung disease will have a dose of 3 - 7 mCi (111 - 185MBq) of ⁶⁸Ga-FAPI-46 administered intravenously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ⁶⁸Ga-FAPI-46Subjects will have 68Ga-FAPI-46 intravenously administered | Drug | ⁶⁸Ga-FAPI-46 PET/CT |
| PET/CTSubjects will complete a PET/CT approximately 60-70 minutes after being given ⁶⁸Ga-FAPI-46 | Diagnostic test | ⁶⁸Ga-FAPI-46 PET/CT |
Primary outcome
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
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
3 secondary outcomes
Specificity of 68Ga-FAPI-46 PET/CT for Detection of Interstitial Lung Disease
Time frame: Baseline
Sensitivity of 68Ga-FAPI-46 PET/CT for Detection of Interstitial Lung Disease
Time frame: Baseline
Accuracy of 68Ga-FAPI-46 PET/CT for Detection of Interstitial Lung Disease
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Livia F. Kruger, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ⁶⁸Ga-FAPI-46 and PET/CT in people with Interstitial Lung Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alicia Meek (507-422-9699, meek.alicia@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Standardized Uptake Value in Abnormal Lung Parenchyma (time frame: Approximately 1 hour post injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.