Ignite Creation Date:
2024-05-06 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03232580
Status:
TERMINATED
Last Update Posted:
2019-12-13
First Post:
2017-07-13
Brief Title:
99mTc-rhAnnexin V-128 in Diagnosis of Spondyloarthritis
Sponsor:
Advanced Accelerator Applications
Organization:
Advanced Accelerator Applications
Study Overview
Official Title:
Phase II Study of 99mTc-rhAnnexin V-128 Radionuclide Imaging in Patients With Clinical Suspicion or Confirmed Diagnosis of Spondyloarthritis SpA
Status:
TERMINATED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor Decision based on strategic considerations
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Annexin 03
Brief Summary:
This single center open-label proof of concept PoC Phase II study aimed to assess the investigational imaging agent 99mTc-rhAnnexin V-128 in detecting spondyloarthritis SpA lesions
Overall it was planned to recruit 20 adults with suspected or confirmed SpA First 5 patients were enrolled into a proof of concept phase to assess the imaging potential of 99mTc-rhAnnexin V-128 in terms of imaging quality disease-lesion radiotracer uptake and medical relevance Based on these results the Data Monitoring Committee DMC was to decide whether to terminate the study or whether to continue and enroll the next 15 planned patients
Overall it was planned to recruit 20 adults with suspected or confirmed SpA First 5 patients were enrolled into a proof of concept phase to assess the imaging potential of 99mTc-rhAnnexin V-128 in terms of imaging quality disease-lesion radiotracer uptake and medical relevance Based on these results the Data Monitoring Committee DMC was to decide whether to terminate the study or whether to continue and enroll the next 15 planned patients
Detailed Description:
The study was prematurely terminated by the sponsor after the first 5 patients completed the PoC phase based on strategic considerations
Novartis acquired Advanced Accelerator Applications SA
Novartis acquired Advanced Accelerator Applications SA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CAAA113A22201 | OTHER | Novartis | None |