An interventional study of 18F-FDG PET + Dexa Scan in Cancer Cachexia, sponsored by Olivia Newton-John Cancer Research Institute. Recruiting at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-23.
Sponsored by Olivia Newton-John Cancer Research Institute · Not applicable, Interventional, and Diagnostic
This is a pilot trial using 18F-FDG PET and DXA scans to determine whether these investigations are objective tools to assess cachexia.
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.
331 studies on the registry are indexed under Cachexia; 75 are open to participants now.
This study's planned enrollment of 40 is below the median of 74 across 226 interventional studies indexed under Cachexia.
Browse Cachexia studies →Olivia Newton-John Cancer Research Institute is the lead sponsor of 14 studies on the registry; 7 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with uncontrolled Diabetes Mellitus;
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
Time frame: 7 days post enrollment
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.
Time frame: 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.
Time frame: 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.
Time frame: 7 days post enrollment
Plan to share: No — Cohort data will be shared via journal and conference presentations
No publications or documents are linked to this record.
Started Mar 2019 (actual). Primary completion is estimated for Dec 2023, 57 months after the start.
Of 75 non-industry interventional studies with no phase under Cachexia, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 49. This study's planned 57 months is above that.
Counting every sponsor, half of 77 studies reached it within 19 months; a quarter within 12 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
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Olivia Newton-John Cancer Research Institute