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Blue Earth Diagnostics Ltd

πŸ‡³πŸ‡΄Norway
Ownership
-
Employees
-
Market Cap
-
Website

Clinical Trials

11

Active:0
Completed:11

Trial Phases

4 Phases

Phase 1:1
Phase 2:1
Phase 3:7
+1 more phases

Drug Approvals

4

FDA:2
EMA:2

Drug Approvals

POSLUMA

Approval Date
Dec 13, 2023
FDA

Axumin

Approval Date
Dec 8, 2023
FDA

Clinical Trials

Distribution across different clinical trial phases (10 trials with phase data)β€’ Click on a phase to view related trials

Phase 3
7 (70.0%)
Phase 1
1 (10.0%)
Phase 2
1 (10.0%)
Phase 4
1 (10.0%)

Intrapatient Comparison of Urinary Radioactivity Following Piflufolastat (18F) and Flotufolastat (18F) PET in Men With Low PSA Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy

Phase 4
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2024-09-19
Last Posted Date
2025-09-11
Lead Sponsor
Blue Earth Diagnostics
Target Recruit Count
55
Registration Number
NCT06604442
Locations
πŸ‡ΊπŸ‡Έ

Mayo Clinic, Jacksonville, Florida, United States

πŸ‡ΊπŸ‡Έ

City of Hope Medical Center, Duarte, California, United States

πŸ‡ΊπŸ‡Έ

Tower Urology, Los Angeles, California, United States

and more 5 locations

Study to Establish Image Interpretation Criteria for 18F Fluciclovine PET in Detecting Recurrent Brain Metastases (PURSUE)

Phase 2
Completed
Conditions
Brain Metastases
Interventions
First Posted Date
2020-06-01
Last Posted Date
2025-07-20
Lead Sponsor
Blue Earth Diagnostics
Target Recruit Count
23
Registration Number
NCT04410367
Locations
πŸ‡ΊπŸ‡Έ

John Wayne Cancer Institute at Providence St. John's Health Center, Santa Monica, California, United States

πŸ‡ΊπŸ‡Έ

Yale School of Medicine, New Haven, Connecticut, United States

πŸ‡ΊπŸ‡Έ

Miami Cancer Institute, Miami, Florida, United States

and more 6 locations

Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases

Phase 3
Completed
Conditions
Brain Metastases
Interventions
First Posted Date
2020-06-01
Last Posted Date
2025-08-28
Lead Sponsor
Blue Earth Diagnostics
Target Recruit Count
151
Registration Number
NCT04410133
Locations
πŸ‡ΊπŸ‡Έ

University of Alabama at Birmingham, Birmingham, Alabama, United States

πŸ‡ΊπŸ‡Έ

St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States

πŸ‡ΊπŸ‡Έ

University of California, San Francisco, San Francisco, California, United States

and more 16 locations

Imaging Study to Investigate Safety and Diagnostic Performance of 18F rhPSMA 7.3 PET Ligand in Suspected Prostate Cancer Recurrence

Phase 3
Completed
Conditions
Prostate Cancer
Interventions
Drug: rhPSMA-7.3 (18F) Injection
Diagnostic Test: Positron emission tomography scan
First Posted Date
2019-12-05
Last Posted Date
2025-02-26
Lead Sponsor
Blue Earth Diagnostics
Target Recruit Count
391
Registration Number
NCT04186845
Locations
πŸ‡ΊπŸ‡Έ

University of Alabama at Birmingham, Birmingham, Alabama, United States

πŸ‡ΊπŸ‡Έ

Tower Urology, Los Angeles, California, United States

πŸ‡ΊπŸ‡Έ

University of California Irvine Medical Center (UCIMC), Orange, California, United States

and more 25 locations

Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer.

Phase 3
Completed
Conditions
Prostate Cancer
Interventions
Drug: rhPSMA-7.3 (18F) Injection
Diagnostic Test: Positron Emission Tomography scan
First Posted Date
2019-12-05
Last Posted Date
2025-02-26
Lead Sponsor
Blue Earth Diagnostics
Target Recruit Count
356
Registration Number
NCT04186819
Locations
πŸ‡ΊπŸ‡Έ

University of Alabama at Birmingham, Birmingham, Alabama, United States

πŸ‡ΊπŸ‡Έ

Tower Urology, Los Angeles, California, United States

πŸ‡ΊπŸ‡Έ

University of California Irvine Medical Center (UCIMC), Orange, California, United States

and more 31 locations
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News

FDA Approves Posluma, First Radiohybrid PSMA-Targeted PET Imaging Agent for Prostate Cancer

The FDA has approved flotufolastat F 18 injection (Posluma) for PET imaging of PSMA-positive lesions in prostate cancer patients, aiding in metastasis detection and recurrence assessment.

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