Medical Imaging of Cachexia

Cancer Cachexia Clinical Trial

Official title:

A Pilot Bioimaging Trial of Cancer Cachexia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04127981
• Other study ID #: ONJ2018-002
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2019
• Est. completion date: December 28, 2023

Study information

• Verified date: March 2023
• Source: Olivia Newton-John Cancer Research Institute
• Contact: Jodie Palmer, PhD
• Phone: 0394963573
• Email: jodie.palmer[@]onjcri.org.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pilot trial using 18F-FDG PET and DXA scans to determine whether these investigations are objective tools to assess cachexia.

Description:

This pilot study will establish the differences in BAT uptake of 18F-FDG in cachectic and non-cachectic cancer patients using PET imaging.

Patients willbe assessed for sarcopenia using a dual energy X-ray absorptiometry or bone densitometry scan (DXA). Given the variables which may affect uptake of BAT in cancer patients, this study will standardise patient preparation and PET scan procedure in order to obtain the most reliable assessment of BAT activity in all patients on study.

It is hypothesisd that use of this PET imaging technique, which is part of standard care to assess cancer progression, may assist clinicians in early identification of metabolic changes in a patient, with potential for early intervention and utility in monitoring success of treatments of cachexia.

A total of 40 patients will be evaluated, 20 patients with advanced/metastatic colorectal, non-small cell lung cancer (NSCLC) or pancreatic cancer without cachexia, and 20 patients with advanced/metastatic colorectal, non-small cell lung cancer (NSCLC), or pancreatic cancer with documented cachexia, all of whom are referred for standard of care 18F-FDG PET scans.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 28, 2023
• Est. primary completion date: December 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with malignant disease;

• ECOG Performance score of 0-2;

• Age = 18 years;

• Life expectancy of >4 months at screening;

• Cachexia patient group only: Fulfils diagnostic criteria for cachexia: unintentional weight loss more than 5% over the previous 6 months, or more than 2% in individuals with a decreased body-mass index of <20kg/m2, or skeletal muscle wasting (sarcopenia).

Exclusion Criteria:

Patients with uncontrolled Diabetes Mellitus;

• Psychological unstable persons presumed unfit to perform the investigations;

• Persons unable to lie or sit still for 1-2 hours;

• Pregnant patients;

• Patients who received high doses of radiotherapeutic radiation of the neck and/or upper chest in their medical history limiting nutritional intake;

• Patients who are receiving any chemotherapeutic agents which is limiting nutritional intake;

• Persons that received cervical or thoracic sympathectomy or have a nerve dysfunction which is likely to influence sympathetic nerves;

• The use of medication that influences the sympathetic nerve system: ß-blockers, a-blockers, central anti-hypertensives, certain anti-depression drugs (MAO inhibitors, tricyclic antidepressives), reserpine, cocaine, calcium channel blockers, labetalol, and certain tranquillizers (fenothiazines).

Related Conditions & MeSH terms

• Cachexia
• Cancer Cachexia

Intervention

Diagnostic Test:
• 18F-FDG PET + Dexa Scan
18F-FDG PET will be compared with Dexa Scan result within and between arms.

Locations

Country	Name	City	State
Australia	Austin Health	Heidelberg	Victoria

Sponsors (3)

Lead Sponsor	Collaborator
Olivia Newton-John Cancer Research Institute	Austin Health, La Trobe University

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of a clinical diagnosis of cachexia with the metabolic activity of brown adipose tissue, bone density and muscle mass.	Quantitation of the metabolic activity of brown adipose tissue, bone density and muscle mass using 18F-FDG uptake and bone densitometry will be correlated with a diagnosis of clinical cachexia.	7 days post enrollment
Secondary	Optimization of PET scanning methods for imaging of brown adipose tissue.	Optimization of the patient environment (ie. ambient temperature) and metabolic state (ie. Heart rate, dietary state) to minimize the impact of these factors and allow direct comparison of metabolic activity of brown adipose tissue between cachectic and non-cachectic patients.	7 days post enrollment
Secondary	To quantify change from normal of inflammatory blood biomarkers	To validate change from normal laboratory range of inflammatory blood based proteins and enzymes in cachectic vs non-cachectic patients.	7 days post enrollment
Secondary	To quantify change from normal of immune blood biomarkers	To validate change from normal laboratory range immune blood based proteins and enzymes in cachectic vs non-cachectic patients.	7 days post enrollment