- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07691775
A Study to Evaluate the Safety and Diagnostic Performance of F18 FBPA PET/CT Imaging in Solid Tumors
Studieoversigt
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiesteder
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Taipei, Taiwan
- Rekruttering
- Taipei Veterans General Hsopital
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Kontakt:
- YuhFeng Wang
- Telefonnummer: (02)28757301
- E-mail: yfwang6@vghtpe.gov.tw
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Subject aged 18-80 (inclusive).
- 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).
- At least one measurable lesion identified on prior imaging evaluation, assessed by RECIST version 1.1.
- Willingness to undergo PET/CT scan.
- Provision of signed informed consent.
Exclusion Criteria:
- Body weight > 80 kg at screening.
- Any contraindication to PET, including active breastfeeding. Female subjects of reproductive potential must have a negative serum pregnancy test at screening.
- History of claustrophobic reactions.
- History of phenylketonuria.
- History of research-related radiation exposure exceeding the Nuclear Safety Commission's current guideline of 50 mSv within the past 12 months.
- 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).
- Subjects from other at-risk populations, including minors, cognitively impaired individuals.
- Suspected or known hypersensitivity (including allergy) to any F18 FBPA components or contrast media
- Hereditary fructose intolerance.
- 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.
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
- 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.
- History of radiation therapy within 3 months prior to the screening visit.
- History of renal impairments, including nephrolithiasis, nephrotic syndrome, or hematuria, and/or other severe renal conditions in the opinion of the investigator.
Studieplan
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 |
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Eksperimentel: F18 FBPA Injection
Single arm treated by F18 FBPA Injection only
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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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
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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
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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To evaluate the applicability of F18 FBPA PET/CT imaging for tumor detection across various solid tumor types.
Tidsramme: 6 months
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To assess the added diagnostic value of F18 FBPA PET/CT for lesion detection and its correlation with clinical staging.
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6 months
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- HN-FBPA-001
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Solid tumor
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Memorial Sloan Kettering Cancer CenterRekrutteringSolid tumor | Solid tumor, voksen | Solid tumor, uspecificeret, voksenForenede Stater
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Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterRekrutteringSolid tumor | Solid tumor, voksen | Solid tumor, uspecificeret, voksenForenede Stater, Puerto Rico
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Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterRekrutteringSolid tumor | Solid tumor, voksen | Solid tumor, uspecificeret, voksenForenede Stater, Puerto Rico
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Memorial Sloan Kettering Cancer CenterRekrutteringSolid tumor | Solid tumor, voksenForenede Stater
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Sorrento Therapeutics, Inc.Trukket tilbageSolid tumor | Recidiverende solid tumor | Refraktær tumor
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Avelos Therapeutics Inc.RekrutteringSolid tumor | Solid tumorkræft | Solid tumor, voksen | Solid tumor, uspecificeret, voksen | Tumor, fast | Solid tumor i avanceret scene | Faste tumorer, der er ildfast til standardterapiKorea, Republikken
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Impact Therapeutics, Inc.RekrutteringSolid tumor | Avanceret solid tumorKina, Australien, Taiwan, Forenede Stater
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Partner Therapeutics, Inc.Trukket tilbageSolid tumor | Solid tumor, voksenForenede Stater
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Neurogene Inc.Merck Sharp & Dohme LLCAfsluttetSolid tumor | Avanceret solid tumorForenede Stater, Australien, Canada
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EMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyAfsluttetSolid tumor | Avanceret solid tumorSpanien, Forenede Stater, Holland, Det Forenede Kongerige
Kliniske forsøg med F18 FBPA Injection
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Stella Pharma CorporationCancer Intelligence Care Systems, Inc.; Sumitomo Heavy Industries, Ltd.Tilmelding efter invitationBrug af CICS-1 og SPM-011 og [18F]FBPA bestilt af CICS og Sumitomo Heavy Industries og STELLA PHARMAThoracic solid ondartet tumorJapan
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Jiangsu HengRui Medicine Co., Ltd.Ikke rekrutterer endnu
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Grand Medical Pty Ltd.Aktiv, ikke rekrutterende
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Beijing Boren HospitalAfsluttetAvanceret solid tumor | Recidiverende/refraktær lymfomKina
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Ruijin HospitalShanghai Essight Bio Co.,LtdRekruttering
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Staidson (Beijing) Biopharmaceuticals Co., LtdAfsluttetAcute respiratory distress syndromKina
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Jiangsu Kanion Pharmaceutical Co., LtdBeijing Bionovo Medicine Development Co., Ltd.Afsluttet
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Johns Hopkins UniversityNational Institute on Aging (NIA)Trukket tilbageSund og rask | Alzheimers sygdomForenede Stater
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Shengjing HospitalJiangsu HengRui Medicine Co., Ltd.RekrutteringHR Positiv/HER2 lav brystkræftKina
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Jeffrey S HeierKato Pharmaceuticals, Inc.AfsluttetVitreomakulær trækkraft | Vitreomakulær vedhæftning | Vitreomakulær vedhæftningForenede Stater