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

NCT01484821 | Completed

• 1 other identifier: CHUBX 2011/29
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

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).

Conditions

Sarcopenia

Keywords

Sarcopenia; ARFI; DEXA; Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

Study Arms (3)

Arm A

ACTIVE COMPARATOR

Volunteers (18 -30 years)

Device: ARFI

Arm B

ACTIVE COMPARATOR

Volunteers (70 years or older)

Device: ARFI

Arm C

EXPERIMENTAL

70 years patient or older with curative cares for cancer

Device: ARFI

Interventions

ARFI DEVICE

Muscle sonoelastography using ARFI(Acoustic Radiation Force Impulse) imaging

Arm A; Arm B; Arm C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Intense activity in 7 preceding days,
• Functional dependency,
• under a legal protection.
• Groups A \& B: serious chronic disease,
• Group C: Palliative care.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (2)

CHU Bordeaux - Hôpital Saint André

Bordeaux, 33000, France

Location

CHU de Bordeaux - Hôpital Haut-Lévêque

Pessac, 33600, France

Location

MeSH Terms

Conditions

Sarcopenia; Neoplasms

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Nora FRULIO, Dr

  University Hospital, Bordeaux, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: December 2, 2011
• Study Start: November 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 13, 2015

Record last verified: 2015-01

Locations

FR (2)