Role of FDG PET, Immune and Hypoxic Marker in NSCLC

NCT02519062 | Completed

• 1 other identifier: 1332
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Carcinoma; Non-Small-Cell Lung; FDG PET; hypoxia markers; immune markers

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

No intervention OTHER

This is a retrospective study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

Related Publications (7)

• 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.

  PMID: 24982822 BACKGROUND

• Saintigny P, Burger JA. Recent advances in non-small cell lung cancer biology and clinical management. Discov Med. 2012 Apr;13(71):287-97.

  PMID: 22541616 BACKGROUND

• 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.

  PMID: 17440684 BACKGROUND

• 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.

  PMID: 27251642 BACKGROUND

• 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.

  PMID: 29608508 BACKGROUND

• 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.

  PMID: 31482306 BACKGROUND

• 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.

  PMID: 30003453 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tumor surgical specimen

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Egesta Lopci, MD

  Humanitas Clinical and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: August 10, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 1, 2020

Record last verified: 2020-09

Locations

IT (1)