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

NCT ID: NCT01484821

Last Updated: 2015-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2014-10-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Arm A

Volunteers (18 -30 years)

Group Type: ACTIVE_COMPARATOR

ARFI

Intervention Type: DEVICE

Muscle sonoelastography using ARFI(Acoustic Radiation Force Impulse) imaging

Arm B

Volunteers (70 years or older)

Group Type: ACTIVE_COMPARATOR

ARFI

Intervention Type: DEVICE

Muscle sonoelastography using ARFI(Acoustic Radiation Force Impulse) imaging

Arm C

70 years patient or older with curative cares for cancer

Group Type: EXPERIMENTAL

ARFI

Intervention Type: DEVICE

Muscle sonoelastography using ARFI(Acoustic Radiation Force Impulse) imaging

Interventions

ARFI

Muscle sonoelastography using ARFI(Acoustic Radiation Force Impulse) imaging

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nora FRULIO, Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux, France

Locations

CHU Bordeaux - Hôpital Saint André

Bordeaux, , France

CHU de Bordeaux - Hôpital Haut-Lévêque

Pessac, , France

Countries

France

Other Identifiers

CHUBX 2011/29

Identifier Type: -

Identifier Source: org_study_id