Knee OsteoarthritisNCT07494838
IMAGES: Identifying Metabolic Imaging Association With Genicular Artery Embolization Success
A study testing Embolization in people with Knee Osteoarthritis and Knee Discomfort, run by Lucas R. Cusumano, MD at 1 site in United States.
Trial summary
Several clinical trials on genicular artery embolization (GAE) show significant clinical benefit for the majority of patients. However, a proportion of patients do not benefit from GAE, and responses vary across individual patients. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis, Knee Discomfort, Knee Pain Chronic
- What is being tested?
- Embolization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provided informed consent
- Age ≥ 40 years
- Ineligibility for or refusal of surgical management
- Moderate-severe knee pain as determined by visual analog scale > 5 out of 10
- Osteoarthritis based on X-ray. Kellgren-Lawrence score > 2 based on radiograph completed within 3 months of procedure date
- Resistant/failed some form of conservative treatment (e.g. NSAIDS/physical therapy/steroid joint injection/hyaluronic acid joint injection) for at least 3 months
- Able to comply with all treatments and protocol follow-up visits
Who cannot join
- Mild knee pain as determined by visual analog scale < 5 out of 10
- OA on knee radiograph resulting in greater than 20 degree varus or valgus angulation
- Moderate loss of kidney function, define as estimated glomerular filtration rate of less than 45 mL/min.
- Significant arterial atherosclerosis that would limit selective angiography
- History of fibromyalgia, autoimmune, or inflammatory disorder
- History of any lumbar spine surgery, spine injections, or radicular pain in the extremity believed to originate from the spine
Show all 13Show fewer
- Allergy to iodinated contrast agents
- Active infection or malignancy
- Recent (within 12 months) or active cigarette use
- Prior total or partial knee replacement in the subject knee
- Active pregnancy
- Uncorrectable bleeding diathesis
- Presence of pacemakers, aneurysm clips, neurostimulators, or any other metal implant not compatible with PET/MRI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lucas Cusumano, MD contact
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
Renato Escobar, (310) 956-6161, raescobar@mednet.ucla.edu
Saima Chaabane, PhD, SChabaane@mednet.ucla.edu
About this study
Several clinical trials on genicular artery embolization (GAE) show significant clinical benefit for the majority of patients. However, a proportion of patients do not benefit from GAE, and responses vary across individual patients. Changes in metabolic activity on non-invasive imaging may correlate with improvement in symptoms of knee osteoarthritis. This study will assess changes in metabolic uptake on a hybrid positron emission tomography/magnetic resonance imaging (PET/MRI) system in subjects undergoing GAE.
- Being tested
- Embolization
- Keywords
- GAE
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmbolizationDevice
Genicular artery embolization
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | Treatment with GAE Receives: Device: Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare metabolic activity
To compare change in metabolic activity detected by PET/MRI as defined as percentage change in maximum standardized uptake value (SUVmax) and incidence of clinical response in patients undergoing GAE as defined as a 50% reduction in Western Ontario and McMaster Universities Arthritis Index (WOMAC).
Measured: Screening, Month 6
Secondary outcomes (6)
Associate changes in metabolic activity detected by PET
To compare change in metabolic activity detected by PET/MRI as defined as percentage change in maximum standardized uptake value (SUVmax) and change of pain over time defined as percent change in Western Ontario and McMaster Universities Arthritis Index (WOMAC).
Measured: Screening, Month 6
Assess osseous metabolic abnormalities correlation with osseous abnormalities and cartilage degeneration
To compare spatial association between MRI Osteoarthritis Knee Score (MOAKS) defined structural abnormalities and metabolic activity. For each subregion, MOAKS scores (cartilage loss and BML size) are graded semi-quantitatively (0 to 3, with higher score representing worse disease) and paired with corresponding standardized uptake value (SUVmax) values derived from co-registered PET data.
Measured: Screening, Month 6
Safety of GAE
Outcome measure: Number of Participants Experiencing Treatment-related Adverse Events, as a Measure of Safety
Measurement description: Treatment-related adverse events from genicular artery embolization during the study period
Measured: Treatment, Month 3, Month 6, Month 12
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as a Measure of Treatment Efficacy
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a self-administered questionnaire consisting of 24 items divided into 3 subscales. Each item is scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). With a total possible range of 0-96, higher scores indicate worse pain, stiffness, and functional limitations.
Pain (5 items, possible range 0-20): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items, possible range 0-8): after first waking and later in the day Physical Function (17 items, possible range 0-68): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties.
Measured: Screen, Month 3, Month 6, Month 12
Change From Baseline in Visual Analog Scale (VAS) as a Measure of Treatment Efficacy
The patient-reported severity of knee pain was quantified using a visual analog scale (VAS) score ranging from 0 (indicating no pain) through 10 (indicating the worst pain imaginable).
Measured: Screen, Month 3, Month 6, Month 12
Assess KOOS5
Change From Baseline in Knee injury and Osteoarthritis Outcome Score, 5th subscale (KOOS5) as a Measure of Treatment Efficacy
KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Each subscale is meant to be scored separately. In this protocol, the 5th subscale (KOOS5) will be used, which measures knee-related quality of life.
Measured: Screen, Month 3, Month 6, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start30 Dec 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lucas R. Cusumano, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lucas R. Cusumano, MD, University of California, Los Angeles
- Investigators
- Lucas Cusumano, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494838
- Sponsor's protocol ID
- 25-2531
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Akira S, Takeda K. Toll-like receptor signalling. Nat Rev Immunol. 2004 Jul;4(7):499-511. doi: 10.1038/nri1391. No abstract available.
PubMed 15229469Ashraf S, Wibberley H, Mapp PI, Hill R, Wilson D, Walsh DA. Increased vascular penetration and nerve growth in the meniscus: a potential source of pain in osteoarthritis. Ann Rheum Dis. 2011 Mar;70(3):523-9. doi: 10.1136/ard.2010.137844. Epub 2010 Nov 15.
PubMed 21081524Bagla S, Piechowiak R, Hartman T, Orlando J, Del Gaizo D, Isaacson A. Genicular Artery Embolization for the Treatment of Knee Pain Secondary to Osteoarthritis. J Vasc Interv Radiol. 2020 Jul;31(7):1096-1102. doi: 10.1016/j.jvir.2019.09.018. Epub 2019 Dec 16.
PubMed 31837946Bagla S, Piechowiak R, Sajan A, Orlando J, Hartman T, Isaacson A. Multicenter Randomized Sham Controlled Study of Genicular Artery Embolization for Knee Pain Secondary to Osteoarthritis. J Vasc Interv Radiol. 2022 Jan;33(1):2-10.e2. doi: 10.1016/j.jvir.2021.09.019. Epub 2021 Oct 2.
PubMed 34610422Berenbaum F. Osteoarthritis as an inflammatory disease (osteoarthritis is not osteoarthrosis!). Osteoarthritis Cartilage. 2013 Jan;21(1):16-21. doi: 10.1016/j.joca.2012.11.012. Epub 2012 Nov 27.
PubMed 23194896Bonomo G, Pedicini V, Monfardini L, Della Vigna P, Poretti D, Orgera G, Orsi F. Bland embolization in patients with unresectable hepatocellular carcinoma using precise, tightly size-calibrated, anti-inflammatory microparticles: first clinical experience and one-year follow-up. Cardiovasc Intervent Radiol. 2010 Jun;33(3):552-9. doi: 10.1007/s00270-009-9752-y. Epub 2009 Dec 3.
PubMed 19957182Chan WP, Lang P, Stevens MP, Sack K, Majumdar S, Stoller DW, Basch C, Genant HK. Osteoarthritis of the knee: comparison of radiography, CT, and MR imaging to assess extent and severity. AJR Am J Roentgenol. 1991 Oct;157(4):799-806. doi: 10.2214/ajr.157.4.1892040.
PubMed 1892040Chandran V, Abji F, Perruccio AV, Gandhi R, Li S, Cook RJ, Gladman DD. Serum-based soluble markers differentiate psoriatic arthritis from osteoarthritis. Ann Rheum Dis. 2019 Jun;78(6):796-801. doi: 10.1136/annrheumdis-2018-214737. Epub 2019 Mar 25.
PubMed 30910989Cheng H, Hao B, Sun J, Yin M. C-Terminal Cross-Linked Telopeptides of Type II Collagen as Biomarker for Radiological Knee Osteoarthritis: A Meta-Analysis. Cartilage. 2020 Oct;11(4):512-520. doi: 10.1177/1947603518798884. Epub 2018 Sep 15.
PubMed 30221987Collins NJ, Misra D, Felson DT, Crossley KM, Roos EM. Measures of knee function: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, Knee Injury and Osteoarthritis Outcome Score (KOOS), Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS), Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL), Lysholm Knee Scoring Scale, Oxford Knee Score (OKS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Activity Rating Scale (ARS), and Tegner Activity Score (TAS). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S208-28. doi: 10.1002/acr.20632. No abstract available.
PubMed 22588746Conde J, Scotece M, Gomez R, Lopez V, Gomez-Reino JJ, Gualillo O. Adipokines and osteoarthritis: novel molecules involved in the pathogenesis and progression of disease. Arthritis. 2011;2011:203901. doi: 10.1155/2011/203901. Epub 2011 Aug 18.
PubMed 22046513Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19.
PubMed 24553908Deyle GD, Allen CS, Allison SC, Gill NW, Hando BR, Petersen EJ, Dusenberry DI, Rhon DI. Physical Therapy versus Glucocorticoid Injection for Osteoarthritis of the Knee. N Engl J Med. 2020 Apr 9;382(15):1420-1429. doi: 10.1056/NEJMoa1905877.
PubMed 32268027Dominick KL, Ahern FM, Gold CH, Heller DA. Health-related quality of life and health service use among older adults with osteoarthritis. Arthritis Rheum. 2004 Jun 15;51(3):326-31. doi: 10.1002/art.20390.
PubMed 15188315Greco G, Cascella T, Facciorusso A, Nani R, Lanocita R, Morosi C, Vaiani M, Calareso G, Greco FG, Ragnanese A, Bongini MA, Marchiano AV, Mazzaferro V, Spreafico C. Transarterial chemoembolization using 40 microm drug eluting beads for hepatocellular carcinoma. World J Radiol. 2017 May 28;9(5):245-252. doi: 10.4329/wjr.v9.i5.245.
PubMed 28634515
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMAGES: Identifying Metabolic Imaging Association With Genicular Artery Embolization Success
- ClinicalTrials.gov ID
- NCT07494838
- Acronym / sponsor ID
- 25-2531
- Keywords
- GAE
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Lucas R. Cusumano, MDUniversity, hospital or other
- Study start
- 30 Dec 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- 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.
Several clinical trials on genicular artery embolization (GAE) show significant clinical benefit for the majority of patients. However, a proportion of patients do not benefit from GAE, and responses vary across individual patients. Changes in metabolic activity on non-invasive imaging may correlate with improvement in symptoms of knee osteoarthritis. This study will assess changes in metabolic uptake on a hybrid positron emission tomography/magnetic resonance imaging (PET/MRI) system in subjects undergoing GAE.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Device: EmbolizationTreatment with GAE |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provided informed consent
- Age ≥ 40 years
- Ineligibility for or refusal of surgical management
- Moderate-severe knee pain as determined by visual analog scale > 5 out of 10
- Osteoarthritis based on X-ray. Kellgren-Lawrence score > 2 based on radiograph completed within 3 months of procedure date
Key exclusion criteria (13 listed)
- Mild knee pain as determined by visual analog scale < 5 out of 10
- OA on knee radiograph resulting in greater than 20 degree varus or valgus angulation
- Moderate loss of kidney function, define as estimated glomerular filtration rate of less than 45 mL/min.
- Significant arterial atherosclerosis that would limit selective angiography
- History of fibromyalgia, autoimmune, or inflammatory disorder
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 |
|---|---|---|
| EmbolizationGenicular artery embolization | Device | Treatment |
Primary outcome
Compare metabolic activity
Time frame: Screening, Month 6
To compare change in metabolic activity detected by PET/MRI as defined as percentage change in maximum standardized uptake value (SUVmax) and incidence of clinical response in patients undergoing GAE as defined as a 50% reduction in Western Ontario and McMaster Universities Arthritis Index (WOMAC).
6 secondary outcomes
Associate changes in metabolic activity detected by PET
Time frame: Screening, Month 6
Assess osseous metabolic abnormalities correlation with osseous abnormalities and cartilage degeneration
Time frame: Screening, Month 6
Safety of GAE
Time frame: Treatment, Month 3, Month 6, Month 12
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as a Measure of Treatment Efficacy
Time frame: Screen, Month 3, Month 6, Month 12
Change From Baseline in Visual Analog Scale (VAS) as a Measure of Treatment Efficacy
Time frame: Screen, Month 3, Month 6, Month 12
Assess KOOS5
Time frame: Screen, Month 3, Month 6, Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 15229469Akira S, Takeda K. Toll-like receptor signalling. Nat Rev Immunol. 2004 Jul;4(7):499-511. doi: 10.1038/nri1391. No abstract available.
- Background: PubMed 21081524Ashraf S, Wibberley H, Mapp PI, Hill R, Wilson D, Walsh DA. Increased vascular penetration and nerve growth in the meniscus: a potential source of pain in osteoarthritis. Ann Rheum Dis. 2011 Mar;70(3):523-9. doi: 10.1136/ard.2010.137844. Epub 2010 Nov 15.
- Background: PubMed 31837946Bagla S, Piechowiak R, Hartman T, Orlando J, Del Gaizo D, Isaacson A. Genicular Artery Embolization for the Treatment of Knee Pain Secondary to Osteoarthritis. J Vasc Interv Radiol. 2020 Jul;31(7):1096-1102. doi: 10.1016/j.jvir.2019.09.018. Epub 2019 Dec 16.
- Background: PubMed 34610422Bagla S, Piechowiak R, Sajan A, Orlando J, Hartman T, Isaacson A. Multicenter Randomized Sham Controlled Study of Genicular Artery Embolization for Knee Pain Secondary to Osteoarthritis. J Vasc Interv Radiol. 2022 Jan;33(1):2-10.e2. doi: 10.1016/j.jvir.2021.09.019. Epub 2021 Oct 2.
- Background: PubMed 23194896Berenbaum F. Osteoarthritis as an inflammatory disease (osteoarthritis is not osteoarthrosis!). Osteoarthritis Cartilage. 2013 Jan;21(1):16-21. doi: 10.1016/j.joca.2012.11.012. Epub 2012 Nov 27.
- Background: PubMed 19957182Bonomo G, Pedicini V, Monfardini L, Della Vigna P, Poretti D, Orgera G, Orsi F. Bland embolization in patients with unresectable hepatocellular carcinoma using precise, tightly size-calibrated, anti-inflammatory microparticles: first clinical experience and one-year follow-up. Cardiovasc Intervent Radiol. 2010 Jun;33(3):552-9. doi: 10.1007/s00270-009-9752-y. Epub 2009 Dec 3.
- Background: PubMed 1892040Chan WP, Lang P, Stevens MP, Sack K, Majumdar S, Stoller DW, Basch C, Genant HK. Osteoarthritis of the knee: comparison of radiography, CT, and MR imaging to assess extent and severity. AJR Am J Roentgenol. 1991 Oct;157(4):799-806. doi: 10.2214/ajr.157.4.1892040.
- Background: PubMed 30910989Chandran V, Abji F, Perruccio AV, Gandhi R, Li S, Cook RJ, Gladman DD. Serum-based soluble markers differentiate psoriatic arthritis from osteoarthritis. Ann Rheum Dis. 2019 Jun;78(6):796-801. doi: 10.1136/annrheumdis-2018-214737. Epub 2019 Mar 25.
- Background: PubMed 30221987Cheng H, Hao B, Sun J, Yin M. C-Terminal Cross-Linked Telopeptides of Type II Collagen as Biomarker for Radiological Knee Osteoarthritis: A Meta-Analysis. Cartilage. 2020 Oct;11(4):512-520. doi: 10.1177/1947603518798884. Epub 2018 Sep 15.
- Background: PubMed 22588746Collins NJ, Misra D, Felson DT, Crossley KM, Roos EM. Measures of knee function: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, Knee Injury and Osteoarthritis Outcome Score (KOOS), Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS), Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL), Lysholm Knee Scoring Scale, Oxford Knee Score (OKS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Activity Rating Scale (ARS), and Tegner Activity Score (TAS). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S208-28. doi: 10.1002/acr.20632. No abstract available.
- Background: PubMed 22046513Conde J, Scotece M, Gomez R, Lopez V, Gomez-Reino JJ, Gualillo O. Adipokines and osteoarthritis: novel molecules involved in the pathogenesis and progression of disease. Arthritis. 2011;2011:203901. doi: 10.1155/2011/203901. Epub 2011 Aug 18.
- Background: PubMed 24553908Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19.
- Individual participant dataSharing planned: No
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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.
Lucas Cusumano, MD contact
Lucas Cusumano, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embolization in people with Knee Osteoarthritis and Knee Discomfort, run by Lucas R. Cusumano, MD 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 7 inclusion and 13 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: opening soon, as of the sponsor's last update on 21 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renato Escobar (310-956-6161, raescobar@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare metabolic activity (time frame: Screening, Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07494838, which also lists 47 linked publications.
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 21 Sep 2026.