Clinical trial NCT05912465: Predicting Lung Cancer-Associated Cachexia With PET Imaging
Official title: The Role of 18F-FDG PET/CT in the Early Prediction of Cachexia in Lung Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cachexia
Lung Neoplasm
Keywords: Cancer cachexia
Positron emission tomography
Metabolic changes
Lung cancer
Muscle wasting
Computed tomography
Fluorodeoxyglucose F18
Organ connection
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: University of Leipzig
name: Careggi Hospital
name: University of Copenhagen
First posted: 2023-06-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Differences in FDG uptake (measured as SUVmean, max, min, peak) in organs, muscle, fat tissue between Cachectic and Non-Cachectic Lung Cancer Patients
timeFrame: F/U for 12 month minimum
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Leipzig
country: Germany
facility: University of Leipzig Medical Center
city: Florence
country: Italy
facility: AOUC Azienda Ospedaliero-Universitaria Careggi
Study officials:
affiliation: Medical University of Vienna, Department of Radiology and Nuclear Medicine
name: Marcus Hacker, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Vienna, Center for Medical Physics and Biomedical Engineering
name: Thomas Beyer, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Leipzig Medical Center
name: Osama Sabri, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Careggi University Hospital
name: Roberto Sciagrà, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.