Predicting Lung Cancer-Associated Cachexia With PET Imaging (LUCAPET)

The Role of 18F-FDG PET/CT in the Early Prediction of Cachexia in Lung Cancer Patients

This prospective observational study aims to investigate the relationship between cancer cachexia, stress levels, and metabolic changes in 150 lung cancer patients. Cancer cachexia, characterized by weight loss and muscle wasting, significantly impacts patient outcomes. Psychological stress is thought to contribute to cachexia development. Assessments will include medical history, physical examinations, laboratory tests, and imaging. Cancer cachexia will be diagnosed based on weight loss, reduced food intake, and inflammation markers. Psychological stress will be evaluated using questionnaires and biomarkers. Metabolic changes will be assessed using positron emission tomography-computed tomography (PET-CT) scans. The primary objective is to determine differences in metabolic activity between cachectic and non-cachectic patients. Secondary objectives include evaluating changes in brain activity and exploring the relationship between stress, inflammation, and metabolism.

Study Overview

• Status: Recruiting
• Conditions: Cachexia; Lung Neoplasm
• Intervention / Treatment: Other: Stress Reduction Training

Detailed Description

Title: Investigation of the Relationship Between Cancer Cachexia, Stress, and Metabolic Changes in Lung Cancer Patients

Background: Cancer cachexia is a debilitating syndrome characterized by progressive weight loss, muscle wasting, and metabolic abnormalities. It significantly impacts patients' quality of life and survival outcomes. Psychological stress has been suggested as a potential contributor to cachexia development and progression. This study aims to investigate the association between cancer cachexia, stress levels, and metabolic changes in lung cancer patients.

Methods: This multicenter, prospective observational study will enroll 150 lung cancer patients. Eligible participants will undergo comprehensive assessments, including medical history review, physical examinations, laboratory tests, and diagnostic imaging. Cancer cachexia will be diagnosed based on established criteria, including weight loss, reduced food intake, and systemic inflammation markers. Psychological stress will be evaluated using validated questionnaires and stress biomarkers. Metabolic changes will be assessed through positron emission tomography-computed tomography (PET-CT) scans to measure fluorodeoxyglucose (FDG) uptake in organs and lesions.

Primary Objectives: The primary objective is to determine differences in FDG uptake between cachectic and non-cachectic lung cancer patients in various organs and lesions. Secondary objectives include evaluating changes in amygdalar FDG uptake after stress intervention and exploring the relationship between stress, inflammatory markers, and metabolic changes.

Statistical Analysis: Student's t-test will be used to compare FDG uptake between groups, and descriptive statistics will be calculated for each brain region. Sample size calculations indicate a need for approximately 30 subjects per group to detect significant differences. Data will be analyzed using appropriate statistical software.

Ethical Considerations: Informed consent will be obtained from all participants, and the study will adhere to the principles outlined in the Declaration of Helsinki and Good Clinical Practice guidelines. The study protocol has been submitted to the Ethics Committee and regulatory authorities for approval.

Conclusion: This study aims to provide insights into the relationship between cancer cachexia, stress, and metabolic changes in lung cancer patients. By investigating FDG uptake in different organs and lesions, as well as amygdalar FDG uptake before and after stress intervention, this research may contribute to the development of targeted interventions for cachexia management and improve patient outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marcus Hacker, Prof., MD; Phone Number: 55310 +43 140400; Email: marcus.hacker@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna
    • Contact: Marcus Hacker, Prof., MD; Phone Number: +43 140400 55310; Email: marcus.hacker@meduniwien.ac.at
    • Sub-Investigator: Josef Yu, MD
    • Sub-Investigator: Andreas Bergthaler, Prof.
• Germany
  • Leipzig, Germany
    • Not yet recruiting
    • University of Leipzig Medical Center
    • Contact: Osama Sabri, Prof.
• Italy
  • Florence, Italy
    • Not yet recruiting
    • AOUC Azienda Ospedaliero-Universitaria Careggi
    • Contact: Roberto Sciagra, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients aged 18 years or older.
• Confirmed diagnosis of lung cancer.
• Willingness to participate in the study and provide informed consent.
• Ability to comply with study procedures and follow-up visits.

Exclusion Criteria:

• Previous history of any other malignancy within the last 5 years, excluding non-melanoma skin cancer.
• Concurrent participation in another clinical trial involving an investigational product.
• Known contraindications or intolerance to PET/CT imaging or fluorodeoxyglucose (FDG).
• Presence of severe comorbidities that may interfere with study participation or affect the interpretation of results.
• Pregnant or lactating women, or those planning to become pregnant during the study period.
• Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment-Naive Lung Cancer Patients; This arm includes 150 treatment-naive lung cancer patients. Assessments include medical history, physical exams, lab tests, and imaging. Objective: investigate cancer cachexia, stress, and metabolic changes. Cachexia criteria: weight loss, reduced food intake, inflammation markers. Stress assessment: questionnaires, biomarkers. Metabolic changes measured by PET-CT scans analyzing FDG uptake in organs/lesions. Data will uncover the relationship between cancer cachexia, stress, and metabolic changes in treatment-naive lung cancer patients, leading to improved interventions/outcomes.

Other: Stress Reduction Training; A subgroup of patients from Vienna will undergo an additional PET/CT scan after the first follow-up PET/CT, which takes place one month after stress reduction training. The stress reduction training involves performing a breathing technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in FDG uptake (measured as SUVmean, max, min, peak) in organs, muscle, fat tissue between Cachectic and Non-Cachectic Lung Cancer Patients	Measurement of fluorodeoxyglucose (FDG) uptake in various organs and lesions to characterize the metabolic differences between cachectic and non-cachectic lung cancer patients.	F/U for 12 month minimum

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: University of Copenhagen; University of Leipzig; Careggi Hospital
• Investigators: Principal Investigator: Marcus Hacker, Prof., Medical University of Vienna, Department of Radiology and Nuclear Medicine; Principal Investigator: Thomas Beyer, Prof., Medical University of Vienna, Center for Medical Physics and Biomedical Engineering; Principal Investigator: Osama Sabri, Prof., University of Leipzig Medical Center; Principal Investigator: Roberto Sciagrà, Prof., Careggi University Hospital

Publications and helpful links

General Publications

• Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4.
• Shiyam Sundar LK, Yu J, Muzik O, Kulterer OC, Fueger B, Kifjak D, Nakuz T, Shin HM, Sima AK, Kitzmantl D, Badawi RD, Nardo L, Cherry SR, Spencer BA, Hacker M, Beyer T. Fully Automated, Semantic Segmentation of Whole-Body 18F-FDG PET/CT Images Based on Data-Centric Artificial Intelligence. J Nucl Med. 2022 Dec;63(12):1941-1948. doi: 10.2967/jnumed.122.264063. Epub 2022 Jun 30.

Helpful Links

• Project Website

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 23, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Computed tomography; Lung cancer; Muscle wasting; Fluorodeoxyglucose F18; Positron emission tomography; Cancer cachexia; Metabolic changes; Organ connection
• Additional Relevant MeSH Terms: Metabolic Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Nutrition Disorders; Body Weight; Respiratory Tract Neoplasms; Thoracic Neoplasms; Body Weight Changes; Weight Loss; Thinness; Lung Neoplasms; Wasting Syndrome; Cachexia
• Other Study ID Numbers: 2091/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No