Safety and Efficacy of a Lipiodol Emulsion for the Embolization of Hypervascularizations in Patients With Knee Pain (LipioJoint1)

NCT04733092 | Completed Phase 1 DMC

• 2 other identifiers: APHP1908912020-002206-10
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Knee osteoarthritis is a common cause of disability in patients who are often young and active. Surgery being an option only for the most severe cases, there is little alternative in case of failure of recommended medication. Inflammatory hypervascularization of the joint is a known source of pain. Temporary embolization of intra-arterial inflammatory hypervascularization has been used since 2012 with good results on pain relief to treat patients with musculoskeletal disorders that are resistant to conventional treatments. Lipiodol® has transient embolizing properties when in emulsion with a contrast agent. It has been used as an emulsion with chemotherapy for the treatment of metastases and primary intra-arterial liver cancer (chemo-embolization) for many years without serious side effects. We hypothesized that Lipiodol® in emulsion could serve as a temporary embolization agent for the treatment of inflammatory hypervascularization responsible for musculoskeletal disorders in humans.

Conditions

Knee Osteoarthritis

Keywords

Lipiodol; musculoskeletal disorders; embolization

Outcome Measures

Primary Outcomes (1)

• Serious Adverse Events (SAE)

  Number of SAE related to Embolization

  1 month

Secondary Outcomes (14)

• Immediate Technical success

  Intraoperative

• Pain improvement 1 week after embolization

  1 week

• Pain improvement 1 month after embolization

  1 month

• Pain improvement 3 month after embolization

  3 months

• Articular impotence improvement 1 week after embolization

  1 week

Study Arms (1)

Embolization

EXPERIMENTAL

Embolization of the inflammatory hypervascularization with a lipiodol emulsion

Drug: Lipiodol

Interventions

Lipiodol DRUG

Lipiodol in emulsion with contrast agent

Also known as: Optiray

Embolization

Eligibility Criteria

• Age: 35 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of primary inflammatory knee osteoarthritis of the target joint defined by a knee osteoarthritis according to the American College of Rheumatology (ACR) classification and a score ≥ 2 according to the classification of Kellgren and Lawrence
• Patient not eligible for surgery (or refusing surgery)
• Analog Visual Scale (VAS) pain ≥ 40 mm despite analgesic treatment for at least 3 months
• Failure or intolerance of treatment with NSAIDs and/or tramadol and/or acetaminophen, and/or failure or intolerance or patient refusing strong opioids medication (morphine, codeine)
• Failure or patient refusal of corticosteroid infiltration
• Patient who has signed an informed consent

You may not qualify if:

• Patient who is unable or unable to comply with the follow-up schedule
• Infiltration of target joint less than three months old
• Treated hyperthyroidism
• Traumatic injury, hemorrhage or bleeding less than 1 week old in the target joint
• Known arterial disease of the lower limbs stage ≥ 2 according to the classification of Leriche and Fontaine
• Known severe allergy to Lipiodol® and/or iodized contrast product
• Known severe kidney failure (creatinine clearance \< 30 ml/min)
• Pregnant or breastfeeding woman
• Patient not affiliated with a French Medicare
• Patient benefiting from legal protection
• Participation in another interventional research

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Guerbet: collaborator

Study Sites (1)

Hôpital européen Georges Pompidou

Paris, 75015, France

Location

Related Publications (1)

• Sapoval M, Querub C, Pereira H, Pellerin O, Boeken T, Di Gaeta A, Ahmar MA, Lefevre-Colau MM, Nguyen C, Daste C, Lacroix M, Laredo JD, Sabatier B, Martelli N, Chatellier G, Dean C, Rannou F. Genicular artery embolization for knee osteoarthritis: Results of the LipioJoint-1 trial. Diagn Interv Imaging. 2024 Apr;105(4):144-150. doi: 10.1016/j.diii.2023.12.003. Epub 2023 Dec 14.

  PMID: 38102013 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Musculoskeletal Diseases

Interventions

Ethiodized Oil; ioversol

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Iodized Oil; Plant Oils; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Marc MD Sapoval, PhD

  AP-HP, Hôpital Européen Georges Pompidou, Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: February 1, 2021
• Study Start: March 3, 2021
• Primary Completion: June 20, 2022
• Study Completion: September 20, 2022
• Last Updated: August 3, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 2 years after the last publication
• Access Criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Data sharing must respect the agreements made with funders. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement. Processing of shared data must comply with European General Data Protection Regulation (GDPR). Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contracting

Locations

FR (1)