Role of FDG PET, Immune and Hypoxic Marker in NSCLC

Carcinoma, Non-Small-Cell Lung Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02519062
• Other study ID #: 1332
• Status: Completed
• Start date: December 2014
• Est. completion date: December 2018

Study information

• Verified date: September 2020
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung

Intervention

Other:
• No intervention
This is a retrospective study

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. — View 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. Review. — View 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. — View 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. Review. — View 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. — View 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. Review. — View Citation

Vaupel P, Mayer A. Hypoxia in cancer: significance and impact on clinical outcome. Cancer Metastasis Rev. 2007 Jun;26(2):225-39. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Baseline SUVmax up to 1 month before surgery.