Correlation of Metabolic Imaging With Immune Markers in NSCLC Candidate to Immunotherapy.

NCT03563482 | Unknown

• 1 other identifier: 1670
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the present study is to prospectively investigate the correlation between the metabolic parameters on FDG-PET before and during immunotherapy treatment with the immune infiltrate and other tissue or circulating markers in a NSCLC patients candidate to immunotherapy.

Conditions

Carcinoma, Non-Small-Cell Lung; Positron-Emission Tomography; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Correlate the tumor expression of immune markers with the metabolic characteristics on FDG-PET in patients with NSCLC candidates to immunotherapy.

  Standardized uptake value

  Baseline

Secondary Outcomes (6)

• Tumor expression of immune markers with the metabolic characteristics on FDG-PET in patients with NSCLC candidates to immunotherapy.

  Before treatment

• Correlate immune markers with the metabolic characteristics on FDG-PET in patients with NSCLC candidates to immunotherapy.

  Baseline

• Evaluate the variation of metabolic parameters on FDG-PET in patients with NSCLC before and 8 weeks after the first administration of immunotherapy.

  After 8 weeks of treatment

• Quantify the variation of metabolic parameters on FDG-PET in patients with NSCLC before and 8 weeks after the first administration of immunotherapy.

  After 8 weeks of treatment

• Evaluate other tissue or circulating markers in patients with NSCLC before and 8 weeks after the first administration of immunotherapy.

  Baseline

Other Outcomes (1)

• Correlate all defined parameters with response to treatment and outcome

  18 months of follow up

Study Arms (1)

Experimental

EXPERIMENTAL

Biopsy and PET scan

Diagnostic Test: PET scan

Interventions

PET scan DIAGNOSTIC_TEST

Tumor biopsy at baseline; PET scan performed after 8 weeks of treatment

Also known as: Biopsy

Experimental

Eligibility Criteria

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

You may qualify if:

• patients with pathological diagnosis of NSCLC eligible for immunotherapy;
• obtained informed consent.

You may not qualify if:

• age \<18 years;
• pregnancy or breast-feeding.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

RECRUITING

Related Publications (17)

• 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, Lopci E. Is it time to change our vision of tumor metabolism prior to immunotherapy? Eur J Nucl Med Mol Imaging. 2018 Jun;45(6):1072-1075. doi: 10.1007/s00259-018-3988-1. Epub 2018 Mar 12. No abstract available.

  PMID: 29532102 BACKGROUND

• Rossi S, Toschi L, Castello A, Grizzi F, Mansi L, Lopci E. Clinical characteristics of patient selection and imaging predictors of outcome in solid tumors treated with checkpoint-inhibitors. Eur J Nucl Med Mol Imaging. 2017 Dec;44(13):2310-2325. doi: 10.1007/s00259-017-3802-5. Epub 2017 Aug 16.

  PMID: 28815334 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, Toschi L, Rossi S, Mazziotti E, Lopci E. The immune-metabolic-prognostic index and clinical outcomes in patients with non-small cell lung carcinoma under checkpoint inhibitors. J Cancer Res Clin Oncol. 2020 May;146(5):1235-1243. doi: 10.1007/s00432-020-03150-9. Epub 2020 Feb 11.

  PMID: 32048008 BACKGROUND

• Rossi S, Castello A, Toschi L, Lopci E. Immunotherapy in non-small-cell lung cancer: potential predictors of response and new strategies to assess activity. Immunotherapy. 2018 Jul;10(9):797-805. doi: 10.2217/imt-2017-0187.

  PMID: 30008262 BACKGROUND

• Castello A, Lopci E. Response assessment of bone metastatic disease: seeing the forest for the trees RECIST, PERCIST, iRECIST, and PCWG-2. Q J Nucl Med Mol Imaging. 2019 Jun;63(2):150-158. doi: 10.23736/S1824-4785.19.03193-5. Epub 2019 Jul 8.

  PMID: 31286751 BACKGROUND

• Castello A, Rossi S, Mazziotti E, Toschi L, Lopci E. Hyperprogressive Disease in Patients with Non-Small Cell Lung Cancer Treated with Checkpoint Inhibitors: The Role of 18F-FDG PET/CT. J Nucl Med. 2020 Jun;61(6):821-826. doi: 10.2967/jnumed.119.237768. Epub 2019 Dec 20.

  PMID: 31862803 BACKGROUND

• Monterisi S, Castello A, Toschi L, Federico D, Rossi S, Veronesi G, Lopci E. Preliminary data on circulating tumor cells in metastatic NSCLC patients candidate to immunotherapy. Am J Nucl Med Mol Imaging. 2019 Dec 15;9(6):282-295. eCollection 2019.

  PMID: 31976158 BACKGROUND

• Castello A, Carbone FG, Rossi S, Monterisi S, Federico D, Toschi L, Lopci E. Circulating Tumor Cells and Metabolic Parameters in NSCLC Patients Treated with Checkpoint Inhibitors. Cancers (Basel). 2020 Feb 19;12(2):487. doi: 10.3390/cancers12020487.

  PMID: 32092983 BACKGROUND

• Castello A, Lopci E. Update on tumor metabolism and patterns of response to immunotherapy. Q J Nucl Med Mol Imaging. 2020 Jun;64(2):175-185. doi: 10.23736/S1824-4785.20.03251-3. Epub 2020 Feb 27.

  PMID: 32107904 BACKGROUND

• Castello A, Rossi S, Toschi L, Mansi L, Lopci E. Soluble PD-L1 in NSCLC Patients Treated with Checkpoint Inhibitors and Its Correlation with Metabolic Parameters. Cancers (Basel). 2020 May 27;12(6):1373. doi: 10.3390/cancers12061373.

  PMID: 32471030 BACKGROUND

• Castello A, Rossi S, Toschi L, Lopci E. Comparison of Metabolic and Morphological Response Criteria for Early Prediction of Response and Survival in NSCLC Patients Treated With Anti-PD-1/PD-L1. Front Oncol. 2020 Jul 31;10:1090. doi: 10.3389/fonc.2020.01090. eCollection 2020.

  PMID: 32850315 BACKGROUND

• Castello A, Lopci E. Reply: Diagnosis of Hyperprogressive Disease in Patients Treated with Checkpoint Inhibitors Using 18F-FDG PET/CT. J Nucl Med. 2020 Sep;61(9):1405. doi: 10.2967/jnumed.120.243444. Epub 2020 Mar 13. No abstract available.

  PMID: 32169909 BACKGROUND

• Lopci E, Haanen JB. Cancer management in the era of immunotherapy: much more than meets the eye. Q J Nucl Med Mol Imaging. 2020 Jun;64(2):141-142. doi: 10.23736/S1824-4785.20.03252-5. Epub 2020 Feb 27. No abstract available.

  PMID: 32107905 BACKGROUND

• Aide N, De Pontdeville M, Lopci E. Evaluating response to immunotherapy with 18F-FDG PET/CT: where do we stand? Eur J Nucl Med Mol Imaging. 2020 May;47(5):1019-1021. doi: 10.1007/s00259-020-04702-4. No abstract available.

  PMID: 31996974 BACKGROUND

• Aide N, Hicks RJ, Le Tourneau C, Lheureux S, Fanti S, Lopci E. FDG PET/CT for assessing tumour response to immunotherapy : Report on the EANM symposium on immune modulation and recent review of the literature. Eur J Nucl Med Mol Imaging. 2019 Jan;46(1):238-250. doi: 10.1007/s00259-018-4171-4. Epub 2018 Oct 5.

  PMID: 30291373 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Positron-Emission Tomography; Biopsy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Egesta Lopci

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele Tedeschi, MD

CONTACT

+390282241; michele.tedeschi@humanitas.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: June 20, 2018
• Study Start: January 1, 2017
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)