Predicting Lung Cancer-Associated Cachexia With PET Imaging

NCT05912465 | Unknown

• 1 other identifier: 2091/2022
• Study Type: interventional
• Target: 150
• Locations: 3 countries
• Sites: 3

Brief Summary

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.

Conditions

Cachexia; Lung Neoplasm

Keywords

Cancer cachexia; Positron emission tomography; Metabolic changes; Lung cancer; Muscle wasting; Computed tomography; Fluorodeoxyglucose F18; Organ connection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Treatment-Naive Lung Cancer Patients

EXPERIMENTAL

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

Interventions

Stress Reduction Training OTHER

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.

Treatment-Naive Lung Cancer Patients

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Vienna: lead
• University of Leipzig: collaborator
• Careggi Hospital: collaborator
• University of Copenhagen: collaborator

Study Sites (3)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

University of Leipzig Medical Center

Leipzig, Germany

NOT YET RECRUITING

AOUC Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

NOT YET RECRUITING

Related Publications (2)

• 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.

  PMID: 35772962 BACKGROUND

• 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.

  PMID: 21296615 BACKGROUND

Related Links

• Project Website

MeSH Terms

Conditions

Cachexia; Lung Neoplasms; Muscular Atrophy

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcus Hacker, Prof., MD

CONTACT

+43 140400; marcus.hacker@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Division of Nuclear Medicine

Model Details: The overall model of this study involves enrolling a total of 150 patients from three different sites. These patients will undergo baseline PET/CT imaging to assess their metabolic changes, as well as provide clinical information through medical history review and physical examinations. Additionally, blood samples will be collected for laboratory tests, and patients will complete questionnaires to evaluate psychological stress levels. This comprehensive approach aims to gather a range of data including imaging, clinical information, blood biomarkers, and psychological assessments to investigate the relationship between cancer cachexia, stress, and metabolic changes in lung cancer patients.

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 22, 2023
• Study Start: July 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: March 1, 2025
• Last Updated: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); AU (1); DE (1)