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Completed

NCT Number: NCT01484821

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Bordeaux - Hôpital Saint André, Bordeaux, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ARFI

Device

Muscle sonoelastography using ARFI(Acoustic Radiation Force Impulse) imaging

Primary outcomes

  1. Viscoelasticity of the contracted Tibialis anterior muscle

    Time frame: Day 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 outcomes

  1. Viscoelasticity of the contracted and relaxed Rectus femoris and Soleus muscles

    Time frame: Day 1 (group A, B and C) and month 6 (group C only)

  2. Distribution curves of subcutaneous thickness in relaxed condition between each group on Rectus femoris and Soleus muscles

    Time frame: Day 1 (group A, B and C) and month 6 (group C only)

  3. Compare fort each muscle the distribution curves of pennation angles in relaxed and contracted conditions between each group on Rectus femoris and Soleus muscles

    Time frame: Day 1 (group A, B and C) and month 6 (group C only)

  4. Evaluate the influence of physical and/or nutritional status, age, and cancer pathology

    Time frame: Day 1 (group A, B and C) and month 6 (group C only)

  5. Evaluate the intra-operator reproducibility

    Time frame: Day 1 (group A, B and C)

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: CAPARFI

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 2, 2011
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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