Une analyse expérimentale (Me-4FDG PET/CT) pour la détection du transport sodium-glucose pour le diagnostic précoce du cancer du poumon
Détection par tomographie par émission de positrons du transport sodium-glucose pour le diagnostic précoce du cancer du poumon
The phase I/II trial assess the safety and efficacy of a new positron emission tomography (PET) test for early diagnosis of lung cancer. This study uses PET and Me-4FDG new glucose tracer (alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside) designed specifically to determine glucose update into cells in the body. PET is a non-invasive imaging method used to detect cancer in patient. Me4FDG is a radioactive glucose tracer used in PET to locate cells in the body taking up glucose by SGLT2. SLGT2 is a sodium glucose transport protein that accumulates glucose in some cells, e.g. kidney cells and tumors. This study may help researcher determine how effective PET with ME4FDG tracer works in detecting lung cancer.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
PRIMARY OBJECTIVE:
I. Assess the safety and efficacy of alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside (Me-4FDG) for early diagnosis of lung cancer.
SECONDARY OBJECTIVE:
I. Evaluate the correlation of Me-4FDG positivity with histopathological features of the disease (tumor grade, expression of sodium-glucose cotransporter-2 inhibitors.(SGLT2).
OUTLINE:
Patients receive Me-4FDG tracer intravenously (IV) and then undergo PET/CT over 15 minutes.
After completion of study , patients are followed up at 7 days.
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Lieux d'étude
-
-
California
-
Los Angeles, California, États-Unis, 90095
- Yesenia Calzada
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age > 18 years
- Lung nodule >= 1 cm visualized by CT imaging
- CANCER ARM: Pathologically confirmed lung adenocarcinoma. For patients who are surgical candidates, the pathologic report on the surgical specimen will confirm the diagnosis. For patients who are not surgical candidates, the enrollment will be contingent upon a pathologic diagnosis of lung cancer obtained by needle biopsy
- BENIGN ARM: Lung nodules considered to be clinically benign, according to the Guidelines for Management of Incidental Pulmonary Nodules from the Fleischner Society. Will consider "benign" the nodules with a lung-RADS score of 1-3
Exclusion Criteria:
- Pregnancy
- Diagnosis of diabetes
- Current treatment with SGLT2 inhibitors or metformin
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 |
|---|---|
|
Expérimental: Diagnostic (Me-4FDG PET/CT)
Patients receive Me-4FDG tracer IV and then undergo PET/CT over 15 minutes. |
Correlative studies Undergo PET/CT
Autres noms:
Undergo PET/CT
Autres noms:
Given IV
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Sensitivity of Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside (Me-4FDG) positron-emission tomography (PET) scans
Délai: within one month of surgery or biopsy
|
Will be determined by calculating the standardized uptake value (SUV) in the lesions and the contrast to noise ratio (CNR) relative to an area of normal lung surrounding the lesion, and evaluated by assessing the percentage of patients with a pathologic diagnosis of lung cancer that results positive at Me-4FDG PET scans. |
within one month of surgery or biopsy
|
|
Specificity of Me-4FDG for lung cancer
Délai: within one week of experimental PET/CT scan
|
Will be estimated by the percentage of Me-4FDG negativity in lung nodules that have been determined radiologically and/or clinically to be benign with a lung-RAD (Lung Imaging Reporting and Data System), score 1-3. |
within one week of experimental PET/CT scan
|
|
Optimal combination of sensitivity and specificity
Délai: within one week of experimental PET/CT scan
|
Will combine SUV and CNR cut-points that yield the optimal combination of sensitivity (positivity within the adenocarcinoma group) and specificity (negativity with the benign group). Optimality will be based on the cut-points that maximize the Youden index (sum of the sensitivity plus specificity). Based on the combined cut point, will construct 95% confidence intervals for the sensitivity and specificity. |
within one week of experimental PET/CT scan
|
|
Incidence of adverse events of Me-4FDG
Délai: From baseline to one week after Me-4FDG administration
|
Will tabulate the number of adverse events (AEs) and the severity of adverse events (SAEs) for the overall population as well as within subjects. |
From baseline to one week after Me-4FDG administration
|
|
Efficacy of Me-4FDG in diagnosing lung cancer
Délai: within one week of the experimental PET/CT scan
|
Will be evaluated by measuring the percentage of test positivity in patients with a pathological diagnosis of lung cancer. |
within one week of the experimental PET/CT scan
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Correlation of Me-4FDG positivity with histopathological features (tumor grade)
Délai: within one month of surgery or biopsy
|
Ordinal logistic regression will be used to assess the correlation between Me-4FDG uptake and tumor grade. |
within one month of surgery or biopsy
|
|
Correlation of Me-4FDG positivity with histopathological features (expression of SGLT2)
Délai: within two months of surgery or biopsy
|
Will be evaluated experimentally with validated specific antibodies. |
within two months of surgery or biopsy
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Claudio Scafoglio, MD, PhD, UCLA / Jonsson Comprehensive Cancer Center
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
Termes MeSH pertinents supplémentaires
- Tumeurs par site
- Tumeurs
- Tumeurs par type histologique
- Tumeurs, glandulaires et épithéliales
- Adénocarcinome
- Tumeurs des voies respiratoires
- Tumeurs thoraciques
- Tumeurs pulmonaires
- Carcinome
- Adénocarcinome du poumon
- Techniques d'investigation
- Techniques de chimie, analytique
- Analyse du spectre
- Spectroscopie de résonance magnétique
- méthyl-4-fluoro-4-désoxyglucose
Autres numéros d'identification d'étude
- 22-000027
- NCI-2022-06770 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
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
produit fabriqué et exporté des États-Unis.
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