Assessment of in Vivo Skeletal Muscle Viscoelasticity (ARFI Imaging) With Aging and Cancer (CAPARFI)
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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 |
- 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.
- 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: | May 2014 |
| Estimated Primary Completion Date: | November 2013 (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 |
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| Contact: Nora FRULIO, Dr | nora.frulio@chu-bordeaux.fr |
| 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 | |
| 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: | February 27, 2013 |
| 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 June 17, 2013