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A Study to Evaluate the Safety and Diagnostic Performance of F18 FBPA PET/CT Imaging in Solid Tumors

2. juli 2026 opdateret af: Heron Neutron Medical Corp.
This Phase I/II clinical study, titled "A Study to Evaluate the Safety and Diagnostic Performance of F18 FBPA PET/CT Imaging in Solid Tumors", aims to evaluate the safety and diagnostic performance of F18 FBPA PET/CT imaging in subjects with solid tumors. The primary objective is to evaluate the safety and establish the optimal screening conditions (including dose, timing and image quality) of F18 FBPA PET/CT in patients with solid tumors.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Taipei, Taiwan
        • Rekruttering
        • Taipei Veterans General Hsopital
        • Kontakt:

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:

  1. Subject aged 18-80 (inclusive).
  2. Histopathological confirmed diagnosis of a solid tumor (including but not limited to osteogenic sarcoma, brain tumors, head and neck cancer, lung cancer, breast cancer, or colorectal cancer).
  3. At least one measurable lesion identified on prior imaging evaluation, assessed by RECIST version 1.1.
  4. Willingness to undergo PET/CT scan.
  5. Provision of signed informed consent.

Exclusion Criteria:

  1. Body weight > 80 kg at screening.
  2. Any contraindication to PET, including active breastfeeding. Female subjects of reproductive potential must have a negative serum pregnancy test at screening.
  3. History of claustrophobic reactions.
  4. History of phenylketonuria.
  5. History of research-related radiation exposure exceeding the Nuclear Safety Commission's current guideline of 50 mSv within the past 12 months.
  6. Inability to lie comfortably in a supine position for more than 60 minutes.as assessed by physical examination and medical history (e.g., back pain, severe arthritis).
  7. Subjects from other at-risk populations, including minors, cognitively impaired individuals.
  8. Suspected or known hypersensitivity (including allergy) to any F18 FBPA components or contrast media
  9. Hereditary fructose intolerance.
  10. A greater risk than normal for potential cardiac arrest such as history of non-compensated congestive heart failure, poorly controlled arrythmias or symptomatic non compensated cardiopathies.
  11. Inadequate organ function within 30 days prior to the F18 FBPA PET/CT, defined as:

    QTc > 460 msec; Serum Albumin < 2.8 mg/mL; Total Bilirubin > 3.0 mg/mL; ALT ≥ 400 U/L and/or AST ≥ 400 U/L; Creatinine < 0.5 mg/dL or > 1.4 mg/dL; eGFR < 60 mL/min/1.73 m2

  12. Any medical or psychiatric conditions under the supervision of the investigator may interfere with optimal participation in the study or place the subject at increased risk of AEs.
  13. History of radiation therapy within 3 months prior to the screening visit.
  14. History of renal impairments, including nephrolithiasis, nephrotic syndrome, or hematuria, and/or other severe renal conditions in the opinion of the investigator.

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: F18 FBPA Injection
Single arm treated by F18 FBPA Injection only
F18 FBPA (4-Borono-2-[18F]fluoro-L-phenylalanine) is a radiolabeled phenylalanine analog used in positron emission tomography (PET) for tumor imaging. Its uptake is mainly facilitated by the L-type amino acid transporter 1 (LAT1), which is commonly overexpressed in malignant tumors. This selective transport mechanism allows F18 FBPA to accumulate preferentially in tumor tissues rather than in normal tissues. Once taken up by cells, the fluorine-18 isotope emits positrons, enabling accurate visualization of tracer distribution through PET imaging.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To evaluate the safety and establish the optimal screening conditions (including dose, timing and image quality) of F18 FBPA PET/CT in patients with solid tumors
Tidsramme: 6 months

Safety: To evaluate the safety profile of F18 FBPA, all cohorts will undergo safety monitoring for up to one week following the F18 FBPA PET/CT scan. Monitoring will include routine assessments of adverse events (AEs), physical examinations, and vital signs.

Diagnostic efficacy: To assess the diagnostic efficacy of F18 FBPA PET/CT by quantifying tracer uptake (SUVmax, SUVmean and SUVpeak), aiming to determine the minimum effective dose and optimal imaging timepoint.

6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To evaluate the applicability of F18 FBPA PET/CT imaging for tumor detection across various solid tumor types.
Tidsramme: 6 months
To assess the added diagnostic value of F18 FBPA PET/CT for lesion detection and its correlation with clinical staging.
6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

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 (Faktiske)

20. maj 2026

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

2. juli 2026

Først indsendt, der opfyldte QC-kriterier

2. juli 2026

Først opslået (Faktiske)

9. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • HN-FBPA-001

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Solid tumor

Kliniske forsøg med F18 FBPA Injection

3
Abonner