Medical Imaging of Cachexia

A Pilot Bioimaging Trial of Cancer Cachexia

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

Study Overview

• Status: Recruiting
• Conditions: Cancer Cachexia
• Intervention / Treatment: Diagnostic test: 18F-FDG PET + Dexa Scan

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jodie Palmer, PhD; Phone Number: 0394963573; Email: jodie.palmer@onjcri.org.au
• Study Contact Backup: Name: Fiona Scott; Phone Number: 0394963335; Email: fiona.scott@onjcri.org.au

Study Locations

• Australia
  • Victoria
    • Heidelberg, Victoria, Australia, 3078
      • Recruiting
      • Austin Health
      • Contact: Lee Sze Ting, MBBS, PhD; Phone Number: +61394969925; Email: szeting.lee@austin.org.au
      • Sub-Investigator: Hui Gan
      • Principal Investigator: Andrew Scott
      • Principal Investigator: Sze Ting Lee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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, α-blockers, central anti-hypertensives, certain anti-depression drugs (MAO inhibitors, tricyclic antidepressives), reserpine, cocaine, calcium channel blockers, labetalol, and certain tranquillizers (fenothiazines).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patients with cancer cachexia; 20 patients with advanced/metastatic colorectal, non-small cell lung cancer (NSCLC), or pancreatic cancer with documented cachexia.	Diagnostic test: 18F-FDG PET + Dexa Scan; 18F-FDG PET will be compared with Dexa Scan result within and between arms.
Active Comparator: Patients without cancer cachexia; 20 patients with advanced/metastatic colorectal, non-small cell lung cancer (NSCLC) or pancreatic cancer without cachexia.	Diagnostic test: 18F-FDG PET + Dexa Scan; 18F-FDG PET will be compared with Dexa Scan result within and between arms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Olivia Newton-John Cancer Research Institute
• Collaborators: Austin Health; La Trobe University
• Investigators: Principal Investigator: Andrew M Scott, MD, Austin Health/ONJCRI

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2019
• Primary Completion (Anticipated): December 28, 2023
• Study Completion (Anticipated): December 28, 2023

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: 18F-FDG PET Scan; Dexa Scan; Quality of Life assessment tools
• Additional Relevant MeSH Terms: Metabolic Diseases; Nutrition Disorders; Body Weight; Body Weight Changes; Emaciation; Weight Loss; Wasting Syndrome; Cachexia; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: ONJ2018-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Cohort data will be shared via journal and conference presentations

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