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Medical Imaging of Cachexia

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

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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)

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2019-03-28

Primary completion: 2023-12-28

Study completion finish: 2023-12-28

Study type

DIAGNOSTIC

Phase

Trial ID

NCT04127981

Intervention or treatment

DIAGNOSTIC_TEST: 18F-FDG PET + Dexa Scan

Conditions

• Cancer Cachexia

Condition: Cancer Cachexia
DIAGNOSTIC_TEST: 18F-FDG PET + Dexa Scan
Heidelberg, Victoria, Australia
Sponsor: Olivia Newton-John Cancer Research Institute

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Austin Health

Research sites nearby

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Austin Health
Heidelberg, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

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

Primary Outcome Measure	Primary Outcome Description	Primary Outcome 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

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome 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

Frequently Asked Questions

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References

Clinical Trials Gov: Medical Imaging of Cachexia