Assessment of in Vivo Skeletal Muscle Viscoelasticity (ARFI Imaging) With Aging and Cancer (CAPARFI)

Sarcopenia is known to be associated with loss in muscle mass that results from a reduced number of muscle fibres, an atrophy of remaining muscle fibres, and an increased infiltration of non-contractile tissue (collagen, fat). Accentuated by cancer and treatments, sarcopenia impairs muscle function resulting in a higher risk of physical disability and death. The commonly used test for sarcopenia screening consists in a DEXA (Dual energy X-ray absorptiometry) scan. However, this test can't provide structural muscle information. In contrast, the mechanical properties of muscle tissue can be explored using an acoustic radiation force impulse (ARFI). The question remains whether muscle sonoelastography using ARFI imaging could be helpful for sarcopenia screening.

For this, volunteers will be recruited in three groups: ≤ 30 years (Gr A) and ≥ 70years, both without any serious chronic disease, and patients ≥ 70 years presenting curative cares for cancer (Gr C).

The volunteers belonging to the groups A and B will be followed during one day. The patients included in the group C will be followed during 6 months. For this latter group; the first visit (t0) will take place before treatment and the second visit will take place 6 months later (t6months) Volunteers will have clinical examinations (weight, stature, BMI, performance status/ ECOG) and will be evaluated on their nutritional status (MNA-SF, 24h dietary recall) and physical capacities (IPAQ, SPPB, lower limb muscle strength, 6-min walk test, QLQ-C30 items relative to the fatigue symptom).

Study Overview

• Status: Completed
• Conditions: Sarcopenia
• Intervention / Treatment: Device: ARFI

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • CHU Bordeaux - Hôpital Saint André
  • Pessac, France, 33600
    • CHU de Bordeaux - Hopital Haut-Leveque

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Men or women 18 years old or more,
• Able to understand the protocol and to give their written consent,
• Health insurance.

Specific inclusion criteria:

• Group A: volunteers 18 to 30 yrs; without any pathology,
• Group B: volunteers ≥ 70 yrs; without any pathology,
• Group C: Performance status (ECOG) < 4; patients included in CAPADOGE study presenting curative cares for cancer by chemotherapy and/ or surgery and/or hormonotherapy and/or radiotherapy.

Exclusion Criteria:

• Intense activity in 7 preceding days,
• Functional dependency,
• under a legal protection.

Specific non-inclusion criteria:

• Groups A & B: serious chronic disease,
• Group C: Palliative care.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm A; Volunteers (18 -30 years)	Device: ARFI; Muscle sonoelastography using ARFI(Acoustic Radiation Force Impulse) imaging
Active Comparator: Arm B; Volunteers (70 years or older)	Device: ARFI; Muscle sonoelastography using ARFI(Acoustic Radiation Force Impulse) imaging
Experimental: Arm C; 70 years patient or older with curative cares for cancer	Device: ARFI; Muscle sonoelastography using ARFI(Acoustic Radiation Force Impulse) imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Viscoelasticity of the contracted Tibialis anterior muscle	Describe and compare the distribution curves of viscoelasticity of the contracted Tibialis anterior muscle, measured by the ARFI shear wave velocity, between each group.	Day 1 (group A, B and C) and month 6 (group C only)

Secondary Outcome Measures

Outcome Measure	Time Frame
Viscoelasticity of the contracted and relaxed Rectus femoris and Soleus muscles	Day 1 (group A, B and C) and month 6 (group C only)
Distribution curves of subcutaneous thickness in relaxed condition between each group on Rectus femoris and Soleus muscles	Day 1 (group A, B and C) and month 6 (group C only)
Compare fort each muscle the distribution curves of pennation angles in relaxed and contracted conditions between each group on Rectus femoris and Soleus muscles	Day 1 (group A, B and C) and month 6 (group C only)
Evaluate the influence of physical and/or nutritional status, age, and cancer pathology	Day 1 (group A, B and C) and month 6 (group C only)
Evaluate the intra-operator reproducibility	Day 1 (group A, B and C)

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Nora FRULIO, Dr, University Hospital, Bordeaux, France

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: November 22, 2011
• First Submitted That Met QC Criteria: November 30, 2011
• First Posted (Estimated): December 2, 2011

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Cancer; Sarcopenia; DEXA; ARFI
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neoplasms; Sarcopenia
• Other Study ID Numbers: CHUBX 2011/29; 2011-A01020-41 (Registry Identifier: ANSM)