- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07817563
Study Evaluating 68GA-FAPI-46 PET/CT in Patients With Interstitial Lung Disease
15. september 2026 opdateret af: Livia Kruger, Mayo Clinic
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
10
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Alicia Meek
- Telefonnummer: 507-422-9699
- E-mail: meek.alicia@mayo.edu
Studiesteder
-
-
Minnesota
-
Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: ⁶⁸Ga-FAPI-46 PET/CT
Subjects with interstitial lung disease will have a dose of 3 - 7 mCi (111 - 185MBq) of ⁶⁸Ga-FAPI-46 administered intravenously
|
Subjects will have 68Ga-FAPI-46 intravenously administered
Subjects will complete a PET/CT approximately 60-70 minutes after being given ⁶⁸Ga-FAPI-46
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Maximum Standardized Uptake Value in Abnormal Lung Parenchyma
Tidsramme: 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
|
Approximately 1 hour post injection
|
|
Maximum Standardized Uptake Value in Normal Lung Parenchyma
Tidsramme: Approximately 1 hour post injection
|
Maximum standardized uptake value (SUVmax) will be measured on 68Ga-FAPI-46 PET/CT in normal lung parenchyma
|
Approximately 1 hour post injection
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Specificity of 68Ga-FAPI-46 PET/CT for Detection of Interstitial Lung Disease
Tidsramme: 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.
|
Baseline
|
|
Sensitivity of 68Ga-FAPI-46 PET/CT for Detection of Interstitial Lung Disease
Tidsramme: 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
|
Baseline
|
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Accuracy of 68Ga-FAPI-46 PET/CT for Detection of Interstitial Lung Disease
Tidsramme: 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.
|
Baseline
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Livia F. Kruger, MD, Mayo Clinic
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
16. oktober 2026
Primær færdiggørelse (Anslået)
1. maj 2030
Studieafslutning (Anslået)
1. maj 2031
Datoer for studieregistrering
Først indsendt
8. september 2026
Først indsendt, der opfyldte QC-kriterier
8. september 2026
Først opslået (Faktiske)
14. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Lungesygdomme
- Lungesygdomme, interstitielle
- Diagnostiske teknikker og procedurer
- Diagnose
- Tomografi
- Diagnostisk billeddannelse
- Radiografi
- Billedtolkning, computerassisteret
- Radiografisk billedforbedring
- Billedforbedring
- Fotografering
- Tomografi, røntgenbillede
- Tomografi, emission-kompettet
- Radionuclide Imaging
- Diagnostiske teknikker, radioisotop
- Positron-emissionstomografi
- Tomografi, røntgenbillede
- Multimodal billeddannelse
- Positronemissionstomografi Computertomografi
Andre undersøgelses-id-numre
- 25-009401
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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