NCT04127981

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2019

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2019

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 16, 2019

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2023

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

4.8 years

First QC Date

April 23, 2019

Last Update Submit

March 21, 2023

Conditions

Cancer Cachexia

Keywords

18F-FDG PET ScanDexa ScanQuality of Life assessment tools

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Optimization of PET scanning methods for imaging of brown adipose tissue.

    7 days post enrollment

  • To quantify change from normal of inflammatory blood biomarkers

    7 days post enrollment

  • To quantify change from normal of immune blood biomarkers

    7 days post enrollment

Study Arms (2)

Patients with cancer cachexia

ACTIVE COMPARATOR

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

Patients without cancer cachexia

ACTIVE COMPARATOR

20 patients with advanced/metastatic colorectal, non-small cell lung cancer (NSCLC) or pancreatic cancer without cachexia.

Diagnostic Test: 18F-FDG PET + Dexa Scan

Interventions

18F-FDG PET + Dexa ScanDIAGNOSTIC_TEST

18F-FDG PET will be compared with Dexa Scan result within and between arms.

Patients with cancer cachexiaPatients without cancer cachexia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Austin Health

Heidelberg, Victoria, 3078, Australia

RECRUITING

MeSH Terms

Interventions

Absorptiometry, Photon

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Andrew M Scott, MD

    Austin Health/ONJCRI

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jodie Palmer, PhD

CONTACT

0394963573jodie.palmer@onjcri.org.au

Fiona Scott

CONTACT

0394963335fiona.scott@onjcri.org.au

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2019

First Posted

October 16, 2019

Study Start

March 28, 2019

Primary Completion

December 28, 2023

Study Completion

December 28, 2023

Last Updated

March 23, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Cohort data will be shared via journal and conference presentations

Locations

AU(1)