Een onderzoeksscan (Me-4FDG PET/CT) voor de detectie van natrium-glucosetransport voor vroege diagnose van longkanker
Positron-emissietomografie Detectie van natrium-glucosetransport voor vroege diagnose van longkanker
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Fase 2
- Fase 1
Contacten en locaties
Studie Locaties
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California
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Los Angeles, California, Verenigde Staten, 90095
- Yesenia Calzada
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Sensitivity of Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside (Me-4FDG) positron-emission tomography (PET) scans
Tijdsspanne: within one month of surgery or biopsy
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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
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Specificity of Me-4FDG for lung cancer
Tijdsspanne: within one week of experimental PET/CT scan
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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
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Optimal combination of sensitivity and specificity
Tijdsspanne: within one week of experimental PET/CT scan
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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
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Incidence of adverse events of Me-4FDG
Tijdsspanne: From baseline to one week after Me-4FDG administration
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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
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Efficacy of Me-4FDG in diagnosing lung cancer
Tijdsspanne: within one week of the experimental PET/CT scan
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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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Correlation of Me-4FDG positivity with histopathological features (tumor grade)
Tijdsspanne: within one month of surgery or biopsy
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Ordinal logistic regression will be used to assess the correlation between Me-4FDG uptake and tumor grade. |
within one month of surgery or biopsy
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Correlation of Me-4FDG positivity with histopathological features (expression of SGLT2)
Tijdsspanne: within two months of surgery or biopsy
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Will be evaluated experimentally with validated specific antibodies. |
within two months of surgery or biopsy
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Claudio Scafoglio, MD, PhD, UCLA / Jonsson Comprehensive Cancer Center
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per site
- Neoplasmata
- Neoplasmata per histologisch type
- Neoplasmata, glandulair en epitheel
- Adenocarcinoom
- Neoplasmata van de luchtwegen
- Thoracale neoplasmata
- Longneoplasmata
- Carcinoom
- Adenocarcinoom van de longen
- Onderzoekstechnieken
- Chemie -technieken, analytisch
- Spectrumanalyse
- Magnetische resonantiespectroscopie
- methyl-4-fluoro-4-deoxyglucose
Andere studie-ID-nummers
- 22-000027
- NCI-2022-06770 (Register-ID: CTRP (Clinical Trial Reporting Program))
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
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