Medical Imaging of Cachexia

NCT ID: NCT04127981

Last Updated: 2023-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-28

Study Completion Date

2023-12-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer Cachexia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with cancer cachexia

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

Group Type ACTIVE_COMPARATOR

18F-FDG PET + Dexa Scan

Intervention Type DIAGNOSTIC_TEST

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

Patients without cancer cachexia

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

Group Type ACTIVE_COMPARATOR

18F-FDG PET + Dexa Scan

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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18F-FDG PET + Dexa Scan

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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La Trobe University

OTHER

Sponsor Role collaborator

Austin Health

OTHER_GOV

Sponsor Role collaborator

Olivia Newton-John Cancer Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew M Scott, MD

Role: PRINCIPAL_INVESTIGATOR

Austin Health/ONJCRI

Locations

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Austin Health

Heidelberg, Victoria, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Jodie Palmer, PhD

Role: CONTACT

0394963573

Fiona Scott

Role: CONTACT

0394963335

Facility Contacts

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Lee Sze Ting, MBBS, PhD

Role: primary

+61394969925

Other Identifiers

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ONJ2018-002

Identifier Type: -

Identifier Source: org_study_id

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