SciaticaNCT02130271
PET/MRI Imaging of Neuraxial Inflammation in Sciatica Patients
An observational study of Sciatica, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to see if the spine shows areas of inflammation using a specific type of imaging (pictures). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sciatica
- What is being tested?
- Radioactive dye, PET/MRI and Blood draw
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Dec 2018
- Phase
- Observational
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Subject is currently diagnosed with lower extremity radicular/sciatica pain. 2. Healthy subjects with no pain from the local community.
Who may be able to join
- Subject is 18-75 years old.
- Subject is able to give written informed consent.
- Subject is currently diagnosed with lower extremity radicular pain regardless of specific or suspected etiologies.
- Subject has a clear dermatomal distribution of the painful area extending to the distal lower extremities.
- Subject reports ongoing pain intensity of 4 or greater using the visual analogue scale (VAS) during the week prior to enrollment.
- Subject is 18-75 years old.
- Subject is able to give written informed consent.
- Subject has no history of chronic back/spine pain.
Who cannot join
- Subject recently received a lumbar ESI (within 8 weeks).
- Subject starts new NSAID medication for pain during the study.
- Subject has predominantly axial low back pain.
- Subject has known pain condition secondary to hip joint arthritis.
- Subject is pregnant or breastfeeding.
- Subject has allergy to lidocaine.
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- Subject is treated with chronic corticosteroid therapy.
- Subject is on anticoagulation therapy (i.e. Coumadin, Plavix, or Lovenox).
- Subject has a known bleeding disorder (i.e. hemophilia).
- Subject has uncontrolled high blood pressure [>170/100].
- Subject has a known heart condition.
- Subject has known inflammatory disease (i.e. inflammatory bowel disease; ankylosing spondylitis; etc.).
- Subject has known liver dysfunction or renal insufficiency or impaired elimination (Renal dysfunction is defined as eGFR < 60. Hepatic dysfunction is defined as LFTs ≥ 3x ULN).
- Subject has been hospitalized recently (within one month) for a major psychiatric disorder (i.e. major depression, bipolar disorder, schizophrenia, anxiety disorder, or psychosis).
- Subject has contraindications to MRI and PET scanning (i.e. presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, or claustrophobia).
- Subject had research-related radiation exposure in the last 12 months.
- Subject tests positive for use of illicit drugs, marijuana, or non-prescribed drugs.
Trial locations and contacts
1 site in 1 country.
United States1 site
MGH Center for Translational Pain Research
Boston, Massachusetts, 02114
About this study
The purpose of this study is to see if the spine shows areas of inflammation using a specific type of imaging (pictures).
Read the detailed description
The purpose of this study is to determine if inflammation around the spinal nerves can be identified using a radioactive tracer [11C] PBR28 and integrated PET/MRI scan for the purpose of better treating patients who have radicular lumbar pain with epidural steroid injections.
- Conditions
- Sciatica
- Being tested
- Radioactive dye, PET/MRI, Blood draw
- Keywords
- Sciatica, PET scan, MRI, Inflammation, Epidural Steroid Injection (ESI)
- Medical subject headings
- Sciatica, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radioactive dyeDrug
Also called [11C]PBR28
The radioactive dye [11C]PBR28 will be administered through an intravenous line (IV).
PET/MRIRadiation
Also called Integrated MR-PET 3 Tesla scanner (Siemens Biograph mMR).
All subjects will undergo a simultaneous PET/MRI scan. The scan will be up to 2 hours long.
Blood drawOther
Up to 11 tablespoons of blood will be drawn through an intravenous line (IV-line) for two purposes: 1) testing for the subject's genetic affinity to the radioactive dye, and 2) testing for the presence inflammatory biomarkers.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Healthy subjects with no pain.
* Radioactive dye
* PET/MRI
* Blood draw Receives: Drug: Radioactive dye; Radiation: PET/MRI; Other: Blood draw | |
| Sciatica | Subjects with sciatica and scheduled for an epidural steroid injection (ESI).
* Radioactive dye
* PET/MRI
* Blood draw Receives: Drug: Radioactive dye; Radiation: PET/MRI; Other: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation in the spine
The presence of inflammation in the spine using the radioactive tracer [11C]PBR28.
Measured: 2 hours
Secondary outcomes (1)
Pain Scores on the Visual Analog Scale (VAS)
The subject's pain score (VAS) at baseline and up to 3 months after the ESI treatment.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2016
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SciaticaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Zhang, MD, Massachusetts General Hospital
- Investigators
- Yi Zhang, MD, PhD., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130271
- Sponsor's protocol ID
- 2013P-002174
- Status last verified
- Sep 2019
- First submitted
- 24 Apr 2014
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET/MRI Imaging of Neuraxial Inflammation in Sciatica Patients
- ClinicalTrials.gov ID
- NCT02130271
- Acronym / sponsor ID
- 2013P-002174
- Conditions
- Sciatica
- Keywords
- Sciatica, PET scan, MRI, Inflammation, Epidural Steroid Injection (ESI)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 5 May 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 study is to see if the spine shows areas of inflammation using a specific type of imaging (pictures).
Detailed description
The purpose of this study is to determine if inflammation around the spinal nerves can be identified using a radioactive tracer [11C] PBR28 and integrated PET/MRI scan for the purpose of better treating patients who have radicular lumbar pain with epidural steroid injections.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Drug: Radioactive dye, Radiation: PET/MRI, Other: Blood drawHealthy subjects with no pain. * Radioactive dye * PET/MRI * Blood draw |
| Sciatica | – | Drug: Radioactive dye, Radiation: PET/MRI, Other: Blood drawSubjects with sciatica and scheduled for an epidural steroid injection (ESI). * Radioactive dye * PET/MRI * Blood draw |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Subject is currently diagnosed with lower extremity radicular/sciatica pain. 2. Healthy subjects with no pain from the local community.
Key inclusion criteria (8 listed)
- Subject is 18-75 years old.
- Subject is able to give written informed consent.
- Subject is currently diagnosed with lower extremity radicular pain regardless of specific or suspected etiologies.
- Subject has a clear dermatomal distribution of the painful area extending to the distal lower extremities.
- Subject reports ongoing pain intensity of 4 or greater using the visual analogue scale (VAS) during the week prior to enrollment.
Key exclusion criteria (17 listed)
- Subject recently received a lumbar ESI (within 8 weeks).
- Subject starts new NSAID medication for pain during the study.
- Subject has predominantly axial low back pain.
- Subject has known pain condition secondary to hip joint arthritis.
- Subject is pregnant or breastfeeding.
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 |
|---|---|---|
| Radioactive dyeAlso: [11C]PBR28The radioactive dye [11C]PBR28 will be administered through an intravenous line (IV). | Drug | Healthy, Sciatica |
| PET/MRIAlso: Integrated MR-PET 3 Tesla scanner (Siemens Biograph mMR).All subjects will undergo a simultaneous PET/MRI scan. The scan will be up to 2 hours long. | Radiation | Healthy, Sciatica |
| Blood drawUp to 11 tablespoons of blood will be drawn through an intravenous line (IV-line) for two purposes: 1) testing for the subject's genetic affinity to the radioactive dye, and 2) testing for the presence inflammatory biomarkers. | Other | Healthy, Sciatica |
Primary outcome
Inflammation in the spine
Time frame: 2 hours
The presence of inflammation in the spine using the radioactive tracer [11C]PBR28.
1 secondary outcome
Pain Scores on the Visual Analog Scale (VAS)
Time frame: up to 3 months
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 16 Sep 2019.
- MGH Center for Translational Pain ResearchLink provided by the sponsor.
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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.
Yi Zhang, MD, PhD. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sciatica, run by Massachusetts General Hospital 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 8 inclusion and 17 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 16 Sep 2019. 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?
Inflammation in the spine (time frame: 2 hours). 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 16 Sep 2019.