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Multicentre Canadian Study to Measure the Safety and Efficacy of Radiosynoviorthesis (RSO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01615991
Recruitment Status : Active, not recruiting
First Posted : June 11, 2012
Last Update Posted : December 4, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

Radiation synovectomy by intra-articular injection of beta-emitting radionuclides is considered a reliable and easy-to-perform therapy without harmful side-effects for the treatment of inflammatory joint disease in many countries.

The goal of this study is to demonstrate Yttrium-90 citrate colloid or Rhenium-186 sulfide synovectomy are appropriate therapeutic interventions in patients with persistent active synovitis of a joint (characterized by pain, tenderness, and effusion) which is resistant to systemic therapy and intra-articular corticosteroid injections.

The primary objective will be to assess the safety of an intra-articular administration of Yttrium-90 citrate colloid or Rhenium-186 sulfide.

The secondary objective will be to assess the efficacy on synovitis.

Condition or disease Intervention/treatment Phase
Arthritis Drug: Radiosynoviorthesis Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicentre Canadian Study to Measure the Safety and Efficacy of Synoviorthesis Performed With Yttrium-90 or Rhenium-186 Sulfide
Study Start Date : May 2012
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Yttrium
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
radiosynoviorthesis with yttrium-90 or rhenium -186
Patients suffering from arthritis or chronic inflammatory joint disease.
Drug: Radiosynoviorthesis
Intraarticular administration from 111 to 222 Mbq yttrium-90 per joint
Other Name: Yttrium-90 colloid suspension for local injection

Outcome Measures

Primary Outcome Measures :
  1. safety [ Time Frame: 3-4 days post -treatment ]
    The safety profile will be assessed by the incidence of AEs. All the AEs will be described by system/organ class and preferred terms and overall sorted by frequency.

Secondary Outcome Measures :
  1. Efficacy [ Time Frame: Clinical response post treatment ]
    Efficacy outcomes will be the clinical response over 1 year post treatment ( at 3, 6 and 12 months):The comparison will be done with a confidence interval approach based on a Chi²-test for each of the above secondary criterion assessed at different times during the follow-up compared to the same criterion assessed at baseline.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • There is no age limit for RSO
  • Patient referred by a medical joint specialist (orthopedist, rheumatologist or internal medicine in the absence of local joint specialist)
  • Patient having a refractory inflammatory articular disease:
  • Failure of medical therapy after 6 months
  • Clinical signs of an active mono or oligo synovitis
  • Joint X-ray, echo or MR showing minimal cartilage or bone destruction
  • Pain limits normal activities or requires significant analgesic medication

Exclusion Criteria:

  • Prior RSO within last 3 months in that joint
  • Collapse of the articular plateau or intra-articular fracture
  • Surgery or arthroscopy within last 6 weeks
  • Painful prosthesis
  • Joint infection, local skin infection, bacteremia
  • Joint puncture within last 2 weeks (increased risk of soft tissue necrosis along the needle track)
  • Pregnancy or breast feeding
  • Synovial cyst rupture
  • Massive hemarthrosis
  • Generalized synovitis defined as more than 5 uncontrolled joints by clinical examination or 3 phases bone scan
  • Surgical synovectomy within 6months
  • Cancer with bone metastases
  • Hypersensitivity, allergies or contraindication to the used radiopharmaceutical agent
  • Participation in any other ongoing clinical trial for the underlying inflammatory condition
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01615991

Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada
Canada, British Columbia
Lion's Gate Hospital
Vancouver, British Columbia, Canada, V7L 2L1
Canada, Manitoba
Health Science Centre
Winnipeg, Manitoba, Canada
Canada, Ontario
Southlake Regional Health Centre
Newmarket, Ontario, Canada
Canada, Quebec
Centre de santé et services sociaux Pierre-Boucher, Hôpital Pierre-Boucher
Longueuil, Quebec, Canada
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
CHR Trois-Rivières
Trois-Rivières, Quebec, Canada
Centre Hospitalier Universitaire de Québec
Quebec, Canada
Sponsors and Collaborators
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Principal Investigator: Eric Turcotte, MD Centre de recherche du Centre hospitalier universitaire de Sherbrooke
More Information

Responsible Party: Dr Éric E Turcotte, MD, Head, Clinical research, Centre d'imagerie moléculaire de Sherbrooke; Associate Professor, Université de Sherbrooke;Nuclear Medecine Specialist, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT01615991     History of Changes
Other Study ID Numbers: CIMS-2012-01
First Posted: June 11, 2012    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: November 2017