Ein Untersuchungsscan (Me-4FDG PET/CT) zum Nachweis des Natrium-Glukose-Transports für die Frühdiagnose von Lungenkrebs
Positronen-Emissions-Tomographie-Nachweis des Natrium-Glucose-Transports zur Früherkennung von Lungenkrebs
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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 2
- Phase 1
Kontakte und Standorte
Studienorte
-
-
California
-
Los Angeles, California, Vereinigte Staaten, 90095
- Yesenia Calzada
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Diagnose
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Diagnostic (Me-4FDG PET/CT)
Patients receive Me-4FDG tracer IV and then undergo PET/CT over 15 minutes. |
Correlative studies Undergo PET/CT
Andere Namen:
Undergo PET/CT
Andere Namen:
Given IV
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Sensitivity of Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside (Me-4FDG) positron-emission tomography (PET) scans
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Correlation of Me-4FDG positivity with histopathological features (tumor grade)
Zeitfenster: 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)
Zeitfenster: within two months of surgery or biopsy
|
Will be evaluated experimentally with validated specific antibodies. |
within two months of surgery or biopsy
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Claudio Scafoglio, MD, PhD, UCLA / Jonsson Comprehensive Cancer Center
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Neubildungen nach Standort
- Neubildungen
- Neubildungen nach histologischem Typ
- Neubildungen, Drüsen und Epithelien
- Adenokarzinom
- Neubildungen der Atemwege
- Thoraxneoplasmen
- Lungentumoren
- Karzinom
- Adenokarzinom der Lunge
- Untersuchungstechniken
- Chemie -Techniken, analytisch
- Spektrumanalyse
- Magnetresonanzspektroskopie
- Methyl-4-Fluor-4-Desoxyglucose
Andere Studien-ID-Nummern
- 22-000027
- NCI-2022-06770 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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