Duchenne Muscular DystrophyNCT02168114
Magnetic Resonance and Optical Imaging of Dystrophic and Damaged Muscle
A study testing Exercising and Optical and Magnetic Resonance Imaging and Spectroscopy in people with Duchenne Muscular Dystrophy, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this research study is to determine the potential of Optical Imaging techniques to detect muscle damage in boys with Duchenne Muscular Dystrophy and unaffected exercised muscle. Healthy subjects will undergo two different exercises in opposite forearms before any imaging techniques are performed. Read more about this study
- Who is it for?
- Ages 10 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Duchenne Muscular Dystrophy
- What is being tested?
- Exercising and Optical and Magnetic Resonance Imaging and Spectroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to 8 Jan 2018
- 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 10 to 55 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Must be older than 18 years of age.
- Must be male.
- Exclusion Criteria for unaffected and Duchenne Muscular Dystrophy subjects:
- Contraindication to an Magnetic Resonance examination (e.g. aneurysm clip, severe claustrophobia, magnetic implants)
- Presence of a condition in patients that impacts muscle function or muscle metabolism (e.g. myasthenia gravis, endocrine disorder, mitochondrial disease)
- Medical condition leading to developmental delay or impaired motor control (e.g. cerebral palsy)
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- Unstable medical condition (e.g. uncontrolled seizure disorder)
- Behavioral problems causing an inability to cooperate during testing
- Control subjects who are participating in sport specific training 2 times or more per week
- History of allergy to iodides
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optical Imaging of Dystrophic and Damaged Muscle
The purpose of this research study is to determine the potential of Optical Imaging techniques to detect muscle damage in boys with Duchenne Muscular Dystrophy and unaffected exercised muscle. Healthy subjects will undergo two different exercises in opposite forearms before any imaging techniques are performed. Boys with Duchenne Muscular Dystrophy will only undergo the imaging techniques without exercise.
Read the detailed description
The overall objective of this proposal is to validate the potential of Optical Imaging techniques to be able to detect and quantify muscle damage in a population affected by Duchenne Muscular Dystrophy, a muscle wasting disease, and in a healthy population that has undergone temporal muscle damage resulting from an exercising intervention.
Duchenne Muscular Dystrophy is a relentlessly progressive degenerative muscle wasting disease, clinically characterized by progressive muscle weakness, a loss of ambulation, and premature mortality. Currently, no known cure exists and treatments that benefit patients diagnosed with Duchenne Muscular Dystrophy are limited. New approaches, such as cell therapy, gene transfer, and pharmacological interventions have shown promising results in animal models and human studies with great potential to develop as effective therapeutic treatments. One of the major limitations of testing these interventions; however. is the lack of effective methods to monitor cellular and tissue changes taking place in the response to therapy. The ability to determine cellular and tissue specific changes in damaged muscles in real time, non-invasively, repeatedly, without exposure to any harmful radiations, with minimal patient discomfort, and at low operating cost would enable high throughput and faster investigation of potential therapies.
The proposed study focuses on the development of Optical Imaging technologies in the near infrared range of wavelengths to differentiate damaged from normal muscle tissue. Near infrared light (700 - 900 nm) has demonstrated the ability to deeply penetrate through biological tissue, skin, and muscle without appreciable attenuation or auto-fluorescence.
The investigators anticipate that Indocyanine Green enhanced Optical Imaging can be used to image exercise induced acute muscle damage in healthy individuals and damaged muscle and in boys with Duchenne Muscular Dystrophy. It is anticipated that this work may fulfill the need for imaging biomarkers that monitor and quantify cellular damage, muscle perfusion, and drug delivery - non-invasively, using benign light, repeatedly, and in real time, with the intention of accelerating the testing of efficacy in clinical trials for neuromuscular disorders. The study is designed to determine the ability of Optical Imaging as a reliable, safe, relatively inexpensive, and facile tool to detect and quantify muscle damage. Investigators anticipate that this type of imaging modality will provide clinically useful information for diagnostic and prognostic purposes in patients with neuromuscular diseases, especially boys with Duchenne Muscular Dystrophy.
- Conditions
- Duchenne Muscular Dystrophy
- Being tested
- Exercising, Optical and Magnetic Resonance Imaging and Spectroscopy
- Keywords
- Duchenne Muscular Dystrophy, Exercise, Optical Imaging, Magnetic Resonance
- Medical subject headings
- Muscular Dystrophy, Duchenne, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExercisingOther
This arm will only include subjects that have a confirmed diagnosis of Duchenne Muscular Dystrophy. Subjects in this arm will not undergo any exercising, and will only be imaged by Optical and Magnetic Resonance Imaging and Spectroscopy techniques at a single time point.
Optical and Magnetic Resonance Imaging and SpectroscopyProcedure or surgery
This arm will contain subjects that are not affected by Duchenne Muscular Dystrophy. These subjects will undergo concentric exercising of one forearm, and eccentric exercising of the contralateral forearm. Two days following the exercising, subjects will undergo Optical Imaging and Magnetic Resonance Imaging and Spectroscopy.
| Study group | Role | What they receive |
|---|---|---|
| Duchenne Muscular Dystrophy | Experimental | This arm will only include subjects that have a confirmed diagnosis of Duchenne Muscular Dystrophy. Subjects in this arm will not undergo any exercising, and will only be imaged by Optical and Magnetic Resonance Imaging and Spectroscopy techniques at a single time point. Receives: Procedure: Optical and Magnetic Resonance Imaging and Spectroscopy |
| Non-affected Subjects | Experimental | This arm will contain subjects that are not affected by Duchenne Muscular Dystrophy. These subjects will undergo concentric exercising of one forearm, and eccentric exercising of the contralateral forearm. Two days following the exercising, subjects will undergo Optical Imaging and Magnetic Resonance Imaging and Spectroscopy. Receives: Other: Exercising; Procedure: Optical and Magnetic Resonance Imaging and Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indocyanine Green accumulation in forearm muscles
Percentage of area with elevated Indocyanine Green in muscle will be an indicator of cell membrane damage and will be measured using Optical Imaging in the forearms of study participants.
Measured: Up to 2 days
Muscle T2 elevation in forearm muscles
Muscle T2 is a noninvasive marker of muscle damage/inflammation and will be measured using Magnetic Resonance in the forearms of participants of this study.
Measured: Up to 2 days
Secondary outcomes (2)
Delayed Onset of Muscle Soreness (DOMS)
DOMS will be correlated to percentage of elevated pixels within forearms of study participants.
Measured: Up to 2 days
Serum Creatine Kinase
Serum Creatine Kinase is a marker of muscle damage and will be correlated to percentage of elevated pixels within forearms of study participants
Measured: Up to 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startJul 2014
- Primary completion8 Jan 2018
- Study completion8 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchenne Muscular DystrophyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Glenn A Walter, Ph.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168114
- Sponsor's protocol ID
- IRB201602354
- Other IDs
- MD110050, 536-2012
- Status last verified
- Jan 2018
- First submitted
- 6 Jun 2014
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Imaging of Dystrophic and Damaged Muscle
- ClinicalTrials.gov ID
- NCT02168114
- Acronym / sponsor ID
- IRB201602354
- Conditions
- Duchenne Muscular Dystrophy
- Keywords
- Duchenne Muscular Dystrophy, Exercise, Optical Imaging, Magnetic Resonance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Jul 2014
- Primary completion
- 8 Jan 2018 (actual)
- Study completion
- 8 Jan 2018 (actual)
- First posted
- 20 Jun 2014 (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.
The purpose of this research study is to determine the potential of Optical Imaging techniques to detect muscle damage in boys with Duchenne Muscular Dystrophy and unaffected exercised muscle. Healthy subjects will undergo two different exercises in opposite forearms before any imaging techniques are performed. Boys with Duchenne Muscular Dystrophy will only undergo the imaging techniques without exercise.
Detailed description
The overall objective of this proposal is to validate the potential of Optical Imaging techniques to be able to detect and quantify muscle damage in a population affected by Duchenne Muscular Dystrophy, a muscle wasting disease, and in a healthy population that has undergone temporal muscle damage resulting from an exercising intervention.
Duchenne Muscular Dystrophy is a relentlessly progressive degenerative muscle wasting disease, clinically characterized by progressive muscle weakness, a loss of ambulation, and premature mortality. Currently, no known cure exists and treatments that benefit patients diagnosed with Duchenne Muscular Dystrophy are limited. New approaches, such as cell therapy, gene transfer, and pharmacological interventions have shown promising results in animal models and human studies with great potential to develop as effective therapeutic treatments. One of the major limitations of testing these interventions; however. is the lack of effective methods to monitor cellular and tissue changes taking place in the response to therapy. The ability to determine cellular and tissue specific changes in damaged muscles in real time, non-invasively, repeatedly, without exposure to any harmful radiations, with minimal patient discomfort, and at low operating cost would enable high throughput and faster investigation of potential therapies.
The proposed study focuses on the development of Optical Imaging technologies in the near infrared range of wavelengths to differentiate damaged from normal muscle tissue. Near infrared light (700 - 900 nm) has demonstrated the ability to deeply penetrate through biological tissue, skin, and muscle without appreciable attenuation or auto-fluorescence.
The investigators anticipate that Indocyanine Green enhanced Optical Imaging can be used to image exercise induced acute muscle damage in healthy individuals and damaged muscle and in boys with Duchenne Muscular Dystrophy. It is anticipated that this work may fulfill the need for imaging biomarkers that monitor and quantify cellular damage, muscle perfusion, and drug delivery - non-invasively, using benign light, repeatedly, and in real time, with the intention of accelerating the testing of efficacy in clinical trials for neuromuscular disorders. The study is designed to determine the ability of Optical Imaging as a reliable, safe, relatively inexpensive, and facile tool to detect and quantify muscle damage. Investigators anticipate that this type of imaging modality will provide clinically useful information for diagnostic and prognostic purposes in patients with neuromuscular diseases, especially boys with Duchenne Muscular Dystrophy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duchenne Muscular Dystrophy | Experimental | Procedure: Optical and Magnetic Resonance Imaging and SpectroscopyThis arm will only include subjects that have a confirmed diagnosis of Duchenne Muscular Dystrophy. Subjects in this arm will not undergo any exercising, and will only be imaged by Optical and Magnetic Resonance Imaging and Spectroscopy techniques at a single time point. |
| Non-affected Subjects | Experimental | Other: Exercising, Procedure: Optical and Magnetic Resonance Imaging and SpectroscopyThis arm will contain subjects that are not affected by Duchenne Muscular Dystrophy. These subjects will undergo concentric exercising of one forearm, and eccentric exercising of the contralateral forearm. Two days following the exercising, subjects will undergo Optical Imaging and Magnetic Resonance Imaging and Spectroscopy. |
Who may qualify
- Ages
- 10 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Must be older than 18 years of age.
- Must be male.
- Contraindication to an Magnetic Resonance examination (e.g. aneurysm clip, severe claustrophobia, magnetic implants)
- Presence of a condition in patients that impacts muscle function or muscle metabolism (e.g. myasthenia gravis, endocrine disorder, mitochondrial disease)
- Medical condition leading to developmental delay or impaired motor control (e.g. cerebral palsy)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ExercisingThis arm will only include subjects that have a confirmed diagnosis of Duchenne Muscular Dystrophy. Subjects in this arm will not undergo any exercising, and will only be imaged by Optical and Magnetic Resonance Imaging and Spectroscopy techniques at a single time point. | Other | Non-affected Subjects |
| Optical and Magnetic Resonance Imaging and SpectroscopyThis arm will contain subjects that are not affected by Duchenne Muscular Dystrophy. These subjects will undergo concentric exercising of one forearm, and eccentric exercising of the contralateral forearm. Two days following the exercising, subjects will undergo Optical Imaging and Magnetic Resonance Imaging and Spectroscopy. | Procedure or surgery | Duchenne Muscular Dystrophy, Non-affected Subjects |
Primary outcome
Indocyanine Green accumulation in forearm muscles
Time frame: Up to 2 days
Percentage of area with elevated Indocyanine Green in muscle will be an indicator of cell membrane damage and will be measured using Optical Imaging in the forearms of study participants.
Muscle T2 elevation in forearm muscles
Time frame: Up to 2 days
Muscle T2 is a noninvasive marker of muscle damage/inflammation and will be measured using Magnetic Resonance in the forearms of participants of this study.
2 secondary outcomes
Delayed Onset of Muscle Soreness (DOMS)
Time frame: Up to 2 days
Serum Creatine Kinase
Time frame: Up to 2 days
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 12 Jan 2018.
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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.
Glenn A Walter, Ph.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercising and Optical and Magnetic Resonance Imaging and Spectroscopy in people with Duchenne Muscular Dystrophy, run by University of Florida at 1 site in United States.
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 10 inclusion and 0 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 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Indocyanine Green accumulation in forearm muscles (time frame: Up to 2 days). The study lists 2 primary outcomes in all. 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 12 Jan 2018.