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Medical Imaging of Cachexia

Primary Purpose

Cancer Cachexia

Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
18F-FDG PET + Dexa Scan
Sponsored by
Olivia Newton-John Cancer Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cancer Cachexia focused on measuring 18F-FDG PET Scan, Dexa Scan, Quality of Life assessment tools

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Austin HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Patients with cancer cachexia

Patients without cancer cachexia

Arm Description

20 patients with advanced/metastatic colorectal, non-small cell lung cancer (NSCLC), or pancreatic cancer with documented cachexia.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
April 23, 2019
Last Updated
March 21, 2023
Sponsor
Olivia Newton-John Cancer Research Institute
Collaborators
La Trobe University, Austin Health
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1. Study Identification

Unique Protocol Identification Number
NCT04127981
Brief Title
Medical Imaging of Cachexia
Official Title
A Pilot Bioimaging Trial of Cancer Cachexia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2019 (Actual)
Primary Completion Date
December 28, 2023 (Anticipated)
Study Completion Date
December 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Olivia Newton-John Cancer Research Institute
Collaborators
La Trobe University, Austin Health

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Cachexia
Keywords
18F-FDG PET Scan, Dexa Scan, Quality of Life assessment tools

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with cancer cachexia
Arm Type
Active Comparator
Arm Description
20 patients with advanced/metastatic colorectal, non-small cell lung cancer (NSCLC), or pancreatic cancer with documented cachexia.
Arm Title
Patients without cancer cachexia
Arm Type
Active Comparator
Arm Description
20 patients with advanced/metastatic colorectal, non-small cell lung cancer (NSCLC) or pancreatic cancer without cachexia.
Intervention Type
Diagnostic Test
Intervention Name(s)
18F-FDG PET + Dexa Scan
Intervention Description
18F-FDG PET will be compared with Dexa Scan result within and between arms.
Primary Outcome Measure Information:
Title
Correlation of a clinical diagnosis of cachexia with the metabolic activity of brown adipose tissue, bone density and muscle mass.
Description
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
Secondary Outcome Measure Information:
Title
Optimization of PET scanning methods for imaging of brown adipose tissue.
Description
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
Title
To quantify change from normal of inflammatory blood biomarkers
Description
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
Title
To quantify change from normal of immune blood biomarkers
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jodie Palmer, PhD
Phone
0394963573
Email
jodie.palmer@onjcri.org.au
First Name & Middle Initial & Last Name or Official Title & Degree
Fiona Scott
Phone
0394963335
Email
fiona.scott@onjcri.org.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew M Scott, MD
Organizational Affiliation
Austin Health/ONJCRI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3078
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Sze Ting, MBBS, PhD
Phone
+61394969925
Email
szeting.lee@austin.org.au
First Name & Middle Initial & Last Name & Degree
Hui Gan
First Name & Middle Initial & Last Name & Degree
Andrew Scott
First Name & Middle Initial & Last Name & Degree
Sze Ting Lee

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Cohort data will be shared via journal and conference presentations

Learn more about this trial

Medical Imaging of Cachexia

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