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

NCT ID: NCT04733092

Last Updated: 2023-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-03
• Study Completion Date: 2022-09-20

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.

Detailed Description

It is a Phase 1, Single-Arm, Open-label, Multicenter Interventional Prospective Study.

In order to ensure the best possible patient safety, a sequential inclusion of the first 6 patients is planned. Thus, the inclusion of each subsequent patient (patient 2-6) will only be considered after reviewing previously included patient safety data. Safety data after the inclusion of each patient (after a step-back of at least one week), as well as the cumulative review of previously included patient safety data, will be brought to the attention of all investigators involved in this research.

In addition, the following information will be transmitted to the Competent Authority without delay:

• a review of the safety and efficacy of the first 3 patients included with a step back for the last patient of at least one week after the administration of the experimental drug, as well as an argument as to the continuation of this research with regard to these data, with a discussion of the risks incurred in relation to the expected profit
• a review of the safety and effectiveness of the first 3 patients after the inclusion of the first 6 patients, as well as an argument as to the continuation of this research with regard to these data, with a discussion of the risks incurred compared to the expected benefit.

The patients will be embolized by the Interventional Radiology Department of the European Hospital Georges Pompidou (HEGP). Embolization will be performed by an experienced radiologist during a conventional hospitalization or a day hospitalization. A clinical follow-up will be carried out at 1 week, 1 month and 3 months after embolization by clinics and patient self-assessment (WOMAC, SF-36).

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Embolization

Embolization of the inflammatory hypervascularization with a lipiodol emulsion

Group Type: EXPERIMENTAL

Lipiodol

Intervention Type: DRUG

Lipiodol in emulsion with contrast agent

Interventions

Lipiodol

Lipiodol in emulsion with contrast agent

Intervention Type: DRUG

Other Intervention Names

Optiray

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guerbet

INDUSTRY

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc MD Sapoval, PhD

Role: PRINCIPAL_INVESTIGATOR

AP-HP, Hôpital Européen Georges Pompidou, Paris

Locations

Hôpital européen Georges Pompidou

Paris, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 38102013 (View on PubMed)

Other Identifiers

2020-002206-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

APHP190891

Identifier Type: -

Identifier Source: org_study_id