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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01484821
Acronym
CAPARFI
Enrollment
65
Registered
2011-12-02
Start date
2011-11-30
Completion date
2014-10-31
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenia

Keywords

Sarcopenia, ARFI, DEXA, Cancer

Brief summary

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).

Interventions

DEVICEARFI

Muscle sonoelastography using ARFI(Acoustic Radiation Force Impulse) imaging

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Viscoelasticity of the contracted Tibialis anterior muscleDay 1 (group A, B and C) and month 6 (group C only)Describe and compare the distribution curves of viscoelasticity of the contracted Tibialis anterior muscle, measured by the ARFI shear wave velocity, between each group.

Secondary

MeasureTime frame
Viscoelasticity of the contracted and relaxed Rectus femoris and Soleus musclesDay 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 musclesDay 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 musclesDay 1 (group A, B and C) and month 6 (group C only)
Evaluate the influence of physical and/or nutritional status, age, and cancer pathologyDay 1 (group A, B and C) and month 6 (group C only)
Evaluate the intra-operator reproducibilityDay 1 (group A, B and C)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026