99mTc-rhAnnexin V-128 in Diagnosis of Spondyloarthritis
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|ClinicalTrials.gov Identifier: NCT03232580|
Recruitment Status : Terminated (Sponsor Decision)
First Posted : July 28, 2017
Last Update Posted : March 12, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Diagnosis of Spondyloarthritis||Drug: rhAnnexin V-128||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of 99mTc-rhAnnexin V-128 Radionuclide Imaging in Patients With Clinical Suspicion or Confirmed Diagnosis of Spondyloarthritis (SpA)|
|Actual Study Start Date :||September 18, 2017|
|Actual Primary Completion Date :||November 12, 2018|
|Actual Study Completion Date :||November 12, 2018|
All patients will receive a single administration of 99mTc-rhAnnexin V-128 at Day 0.
Drug: rhAnnexin V-128
Patients will receive a single administration of 99mTc-rhAnnexin V-128 at Day 0
- 99mTc-rhAnnexin V-128 uptake [ Time Frame: 1 Month ]uptake compared with background should be assessed for each affected area by nuclear medicine physicians using a 4-grade scoring system (e.g. 0, none; 1, mild or present but < to background uptake; 2, moderate or = to background uptake; 3, intense or > to background uptake).
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): NCT03232580
|United States, California|
|Cedars Sinai Medical Center|
|Los Angeles, California, United States, 90048|