- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07691775
A Study to Evaluate the Safety and Diagnostic Performance of F18 FBPA PET/CT Imaging in Solid Tumors
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Lieux d'étude
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Taipei, Taïwan
- Recrutement
- Taipei Veterans General Hsopital
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Contact:
- YuhFeng Wang
- Numéro de téléphone: (02)28757301
- E-mail: yfwang6@vghtpe.gov.tw
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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To evaluate the applicability of F18 FBPA PET/CT imaging for tumor detection across various solid tumor types.
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- HN-FBPA-001
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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