A Phase 1 interventional study of ⁶⁸Ga-FAPI-46 and PET/CT in Interstitial Lung Disease, sponsored by Mayo Clinic. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Mayo Clinic · Phase 1, Interventional, and Diagnostic
Among 201 studies in Lung Diseases, Interstitial with a site in United States — 69 open to participants now, 83 under way, 19 of them phase 3. Lung Diseases, Interstitial · United States.
Among the 201 studies in Lung Diseases, Interstitial with a site in United States, this one is the 123rd largest by planned enrollment of the 138 interventional ones, is one of 26 that started in 2026, is one of 12 in phase 1, reaches primary completion later than 69 of the 82 other live ones, and was the 200th registered.
680 studies on the registry are indexed under Lung Diseases, Interstitial; 246 are open to participants now.
This study's planned enrollment of 10 is below the median of 60 across 384 interventional studies indexed under Lung Diseases, Interstitial.
Browse Lung Diseases, Interstitial studies →69 of the 201 studies in Lung Diseases, Interstitial with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 174 Lung Diseases, Interstitial studies recruiting now, 109 (63%) set no upper age limit and 26 (15%) stop at 75 or younger; 13 take children under 18; 22 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →201 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 26 started in 2026.
Median enrollment 53 across the 138 interventional studies, 327 across the 60 observational. Of the 105 that completed or were terminated, 51 (49%) have results posted.
79 of 201 have an industry lead sponsor. The 10 most frequent:
Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Mayo Clinic has 7 studies filed under Lung Diseases, Interstitial — fewer than ten, so there is no comparison to draw.
24 of the studies in Lung Diseases, Interstitial with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05925803Phase 3AstraZenecaDetermine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY) | 2027-01-06 |
| NCT06806592Phase 3Boehringer IngelheimA Study to Test Whether Nerandomilast Helps People With Lung Fibrosis Related to Rheumatic Diseases | 2027-04-15 |
| NCT05943535Phase 3United TherapeuticsStudy of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF) | 2027-11 |
| NCT06195072Scleroderma Research Foundation, Inc.Platform Clinical Study for Conquering Scleroderma | 2026-11 |
| NCT07333183Pulmovant, Inc.A Study of Mosliciguat in Combination With Inhaled Treprostinil in PH-ILD | 2026-12 |
Among the 201 studies in Lung Diseases, Interstitial with a site in United States, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects with interstitial lung disease will have a dose of 3 - 7 mCi (111 - 185MBq) of ⁶⁸Ga-FAPI-46 administered intravenously
Drug: ⁶⁸Ga-FAPI-46 · Diagnostic Test: PET/CT
Subjects will have 68Ga-FAPI-46 intravenously administered
Subjects will complete a PET/CT approximately 60-70 minutes after being given ⁶⁸Ga-FAPI-46
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
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
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
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
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
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for May 2030, 43 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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