SarcopeniaCAPARFINCT01484821
Assessment of in Vivo Skeletal Muscle Viscoelasticity (ARFI Imaging) With Aging and Cancer
A study testing ARFI in people with Sarcopenia, run by University Hospital, Bordeaux at 2 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- ARFI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesFrance
- Study dates
- Nov 2011to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Bordeaux - Hôpital Saint André
Bordeaux, 33000
CHU de Bordeaux - Hôpital Haut-Lévêque
Pessac, 33600
About this study
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
- Being tested
- ARFI
- Keywords
- Sarcopenia, ARFI, DEXA, Cancer
- Medical subject headings
- Sarcopenia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARFIDevice
Muscle sonoelastography using ARFI(Acoustic Radiation Force Impulse) imaging
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Volunteers (18 -30 years) Receives: Device: ARFI |
| Arm B | Active comparator | Volunteers (70 years or older) Receives: Device: ARFI |
| Arm C | Experimental | 70 years patient or older with curative cares for cancer Receives: Device: ARFI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 1 (group A, B and C) and month 6 (group C only)
Evaluate the intra-operator reproducibility
Measured: Day 1 (group A, B and C)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionApr 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nora FRULIO, Dr, Principal investigator, University Hospital, Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484821
- Sponsor's protocol ID
- CHUBX 2011/29
- Other IDs
- 2011-A01020-41
- Acronym
- CAPARFI
- Status last verified
- Jan 2015
- First submitted
- 22 Nov 2011
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of in Vivo Skeletal Muscle Viscoelasticity (ARFI Imaging) With Aging and Cancer
- ClinicalTrials.gov ID
- NCT01484821
- Acronym / sponsor ID
- CAPARFI / CHUBX 2011/29
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia, ARFI, DEXA, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 2 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Device: ARFIVolunteers (18 -30 years) |
| Arm B | Active comparator | Device: ARFIVolunteers (70 years or older) |
| Arm C | Experimental | Device: ARFI70 years patient or older with curative cares for cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (6 listed)
- Intense activity in 7 preceding days,
- Functional dependency,
- under a legal protection.
- Groups A \& B: serious chronic disease,
- Group C: Palliative care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARFIMuscle sonoelastography using ARFI(Acoustic Radiation Force Impulse) imaging | Device | Arm A, Arm B, Arm C |
Primary outcome
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.
5 secondary outcomes
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)
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)
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)
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)
Evaluate the intra-operator reproducibility
Time frame: Day 1 (group A, B and C)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nora FRULIO, Dr principal investigator
University Hospital, Bordeaux, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARFI in people with Sarcopenia, run by University Hospital, Bordeaux at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viscoelasticity of the contracted Tibialis anterior muscle (time frame: Day 1 (group A, B and C) and month 6 (group C only)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.