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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01484821
First received: November 22, 2011
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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).


Condition Intervention
Sarcopenia
Device: ARFI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Viscoelasticity of the contracted Tibialis anterior muscle [ Time Frame: Day 1 (group A, B and C) and month 6 (group C only) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Evaluate the intra-operator reproducibility [ Time Frame: Day 1 (group A, B and C) ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: November 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01484821

Contacts
Contact: Nora FRULIO, Dr nora.frulio@chu-bordeaux.fr

Locations
France
CHU Bordeaux - Hôpital Saint André Recruiting
Bordeaux, France, 33000
Contact: Sophie REGUEME, Dr       sophie.regueme@chu-bordeaux.fr   
Principal Investigator: Nora FRULIO, Dr         
Sub-Investigator: Isabelle BOURDEL-MARCHASSON, Pr         
CHU de Bordeaux - Hôpital Haut-Lévêque Recruiting
Pessac, France, 33600
Contact: Sophie REGUEME         
Principal Investigator: Claire AUDER, MD         
Sub-Investigator: Julie BERNARD, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Nora FRULIO, Dr University Hospital, Bordeaux, France
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01484821     History of Changes
Other Study ID Numbers: CHUBX 2011/29
Study First Received: November 22, 2011
Last Updated: April 1, 2014
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Bordeaux:
Sarcopenia
ARFI
DEXA
Cancer

Additional relevant MeSH terms:
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014