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CompletedNCT02519062Updated Oct 1, 2020

Role of FDG PET, Immune and Hypoxic Marker in NSCLC

An observational study in Carcinoma, Non-Small-Cell Lung, sponsored by Istituto Clinico Humanitas. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-01.

Sponsored by Istituto Clinico Humanitas · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
130
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Carcinoma, Non-Small-Cell Lung

Keywords

  • Carcinoma
  • Non-Small-Cell Lung
  • FDG PET
  • hypoxia markers
  • immune markers
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.

This study's enrollment of 130 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Istituto Clinico Humanitas is the lead sponsor of 275 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
130 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • OtherNo intervention

    This is a retrospective study

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What researchers measure

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.

    Time frame: Baseline SUVmax up to 1 month before surgery.

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Study locations

1 site
  • Istituto Clinico Humanitas
    Rozzano, Milano 20089, Italy
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References and documents

Publications

  • 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. PubMed 24982822 ↗
  • Saintigny P, Burger JA. Recent advances in non-small cell lung cancer biology and clinical management. Discov Med. 2012 Apr;13(71):287-97. PubMed 22541616 ↗
  • 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. PubMed 17440684 ↗
  • 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. PubMed 27251642 ↗
  • 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. PubMed 29608508 ↗
  • 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. PubMed 31482306 ↗
  • 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. PubMed 30003453 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02519062
Lead sponsor
Istituto Clinico Humanitas
Responsible party
Sponsor
First posted
Aug 10, 2015
Start date
Dec 2014
Primary completion
Dec 2018
Completion
Dec 2018
Last update
Oct 1, 2020

Study contacts

Egesta Lopci, MD
principal investigator · Humanitas Clinical and Research Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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