Clinical trial · Observational
Retrospective Observational Study Investigating Fluciclovine (18F) (FACBC)
A Retrospective Observational Study Investigating the Safety and Effectiveness of Fluciclovine (18F) (FACBC) PET Ligand in Human Subjects
NCT02443571CI-TRIAL-00036181completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This retrospective observational multi centered study has been established to collect the clinical experience relating to the administration of Fluciclovine 18F employed in both investigator initiated studies and named patient/compassionate use programmes in up to 5 sites.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluciclovine (18F) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
- timeFrame
- Up to 35 days post Fluciclovine 18F
- description
- Treatment-emergent Adverse Events and Treatment-Emergent Serious Adverse Events
- measure
- Positive Predictive Value of FACBC Compared to Histology to Detect Recurrence in Patients Previously Diagnosed With Prostate Cancer
- timeFrame
- Up to 1 year post Fluciclovine 18F
- description
- Positive Predictive Value is the percentage of participants with a positive Fluciclovine 18F scan who truly have positive finding in biopsy.
- measure
- Positive Predictive Value of FACBC to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer
- timeFrame
- Up to 1 year post Fluciclovine 18F
- description
- Positive Predictive Value is the percentage of participants with a positive Fluciclovine 18F scan who truly have positive finding in biopsy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient managed by a site at which ethical committee approval for retrospective data collection under this protocol has been received * Patient has received at least one injection of fluciclovine (18F) for the detection of a malignant tumour at any location Exclusion Criteria: * Subjects will be excluded from the analyses if any of the following criteria are met: * Patients participating in clinical trials or open access programmes at countries or sites not participating in this study. * Patients managed at sites without ethical committee approval for retrospective data collection under this protocol.
References
Publications (1)
- RESULTBach-Gansmo T, Nanni C, Nieh PT, Zanoni L, Bogsrud TV, Sletten H, Korsan KA, Kieboom J, Tade FI, Odewole O, Chau A, Ward P, Goodman MM, Fanti S, Schuster DM, Willoch F. Multisite Experience of the Safety, Detection Rate and Diagnostic Performance of Fluciclovine (18F) Positron Emission Tomography/Computerized Tomography Imaging in the Staging of Biochemically Recurrent Prostate Cancer. J Urol. 2017 Mar;197(3 Pt 1):676-683. doi: 10.1016/j.juro.2016.09.117. Epub 2016 Oct 13. PMID 27746282