Clinical trial NCT02519062: Role of FDG PET, Immune and Hypoxic Marker in NSCLC
Official title: FDG-PET, Marker Immunologici ed Ipossici in Pazienti Affetti da Carcinoma Polmonare Non a Piccole Cellule in Stadio I-III Sottoposti a Chirurgia Radicale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Carcinoma
Non-Small-Cell Lung
FDG PET
hypoxia markers
immune markers
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2015-08-10
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will recruit a maximum number of 130 NSCLC patients operated radically (stage I-III) at our institution during 2010-2014, of which are available clinical and instrumental data and surgical tumor specimen.

Brief summary: This is a retrospective study that involves the revision of clinical, instrumental and pathologic data of an estimated cohort of maximum 130 patients with NSCLC treated with surgery with radical intent at our center.

Detailed description: This is a retrospective observation that involves the revision of clinical, instrumental and pathologic data of an estimated cohort of 130 patients with NSCLC treated with surgery with radical intent at our center.

We will review FDG-PET acquired within 30 days prior to surgery and analyze its principal imaging characteristics with respect to hypoxic and immune-related markers at immunohistochemistry (IHC). These markers will be studied on tumor tissue obtained at surgery, used for diagnostic purposes and stored in paraffin.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of NSCLC (Stage I-III)
* FDG PET before surgery

Exclusion Criteria:

* Absence of tumor specimen
* No clinical data
* FDG-PET can not be evaluated

Primary outcomes:
measure: Correlation of SUVmax (Maximal Standardized Uptake Value) in patients with non-small cell lung cancer undergoing surgery with hypoxia expression and tumor immune cell infiltration.
timeFrame: Baseline SUVmax up to 1 month before surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
Study officials:
affiliation: Humanitas Clinical and Research Hospital
name: Egesta Lopci, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lopci E, Grassi I, Chiti A, Nanni C, Cicoria G, Toschi L, Fonti C, Lodi F, Mattioli S, Fanti S. PET radiopharmaceuticals for imaging of tumor hypoxia: a review of the evidence. Am J Nucl Med Mol Imaging. 2014 Jun 7;4(4):365-84. eCollection 2014.
citation: Saintigny P, Burger JA. Recent advances in non-small cell lung cancer biology and clinical management. Discov Med. 2012 Apr;13(71):287-97.
citation: Vaupel P, Mayer A. Hypoxia in cancer: significance and impact on clinical outcome. Cancer Metastasis Rev. 2007 Jun;26(2):225-39. doi: 10.1007/s10555-007-9055-1.
citation: Lopci E, Toschi L, Grizzi F, Rahal D, Olivari L, Castino GF, Marchetti S, Cortese N, Qehajaj D, Pistillo D, Alloisio M, Roncalli M, Allavena P, Santoro A, Marchesi F, Chiti A. Correlation of metabolic information on FDG-PET with tissue expression of immune markers in patients with non-small cell lung cancer (NSCLC) who are candidates for upfront surgery. Eur J Nucl Med Mol Imaging. 2016 Oct;43(11):1954-61. doi: 10.1007/s00259-016-3425-2. Epub 2016 Jun 1.
citation: Castello A, Grizzi F, Toschi L, Rossi S, Rahal D, Marchesi F, Russo C, Finocchiaro G, Lopci E. Tumor heterogeneity, hypoxia, and immune markers in surgically resected non-small-cell lung cancer. Nucl Med Commun. 2018 Jul;39(7):636-644. doi: 10.1097/MNM.0000000000000832.
citation: Grizzi F, Castello A, Qehajaj D, Toschi L, Rossi S, Pistillo D, Paleari V, Veronesi G, Novellis P, Monterisi S, Mineri R, Rahal D, Lopci E. Independent expression of circulating and tissue levels of PD-L1: correlation of clusters with tumor metabolism and outcome in patients with non-small cell lung cancer. Cancer Immunol Immunother. 2019 Sep;68(9):1537-1545. doi: 10.1007/s00262-019-02387-9. Epub 2019 Sep 3.
citation: Grizzi F, Castello A, Qehajaj D, Russo C, Lopci E. The Complexity and Fractal Geometry of Nuclear Medicine Images. Mol Imaging Biol. 2019 Jun;21(3):401-409. doi: 10.1007/s11307-018-1236-5.