99mTc-rhAnnexin V-128 in Diagnosis of Spondyloarthritis
Twenty evaluable patients with clinical suspicion or confirmed diagnosis of spondyloarthritis due to ankylosing spondylitis, or associated with other known clinical conditions like inflammatory bowel disease, psoriatic arthritis, or undifferentiated spondyloarthropathy. Five patients will be recruited in the first part of the trial, as a Proof of Concept (PoC) phase. The PoC phase will assess the imaging potential of 99mTc-rhAnnexin V-128 in terms of imaging quality, disease-lesion radiotracer uptake and medical relevance to enable the decision-making to terminate or to continue the clinical investigation completing the enrollment with the remaining 15 patients.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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|Eligible Ages||18 Years and Over|
Inclusion Criteria:For the first 5 patients enrolled in the POC part: 1. Patients with clinical suspicion or confirmed diagnosis of SpA, based on the ASA criteria with active symptoms including back, hip or buttock pain prior to:
- - A change in NSAID therapy or - A change in non-biologic DMARD or - A start of non-biologic DMARD.
- - A change in NSAIDs therapy - A change in non-biologic DMARD - A start of non-biologic DMARD - A start of biologic DMARD For all patients: 2.
Exclusion Criteria:1. Pregnancy or lactation 2. Liver impairment (ALT, AST or Bilirubin > 2 ULN) at screening visit or baseline 3. Kidney impairment (serum creatinine > 1.5 mg/dL) 4. History of any disease or relevant physical or psychiatric condition or abnormal physical finding which may interfere with the study objectives at the investigator judgment 5. Known hypersensitivity to the investigational drug or any of its components 6. Contraindication(s) to the MRI procedure (claustrophobia, prosthetic valve, pacemaker, inability to lie still in a supine position) 7. Participation to another clinical trial within 4 weeks before study inclusion except for patients who have participated or who are currently participating in an interventional study without any study drug administration.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Advanced Accelerator Applications|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Diagnosis of Spondyloarthritis|
Contact a Trial Team
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Cedars Sinai Medical Center
Los Angeles, California, 90048
Alan Waxman, MD