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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.
This study will collect clinical data from consenting patients (unless a HIPAA waiver or equivalent was granted) who received the PET radiotracer Fluciclovine 18F (FACBC) (a synthetic amino acid analog) for imaging of patients with various cancers at participating sites in the US and Europe.
Data collection will cover baseline medical history and medications in all patients.
The result of PET radiotracer and other imaging findings, and reports of histopathology from biopsied tissue (where available) and in a time window relevant to the use of PET imaging in the diagnosis of primary/recurrent prostate cancer will be recorded.
In all subjects, with regards to safety monitoring, available data for physical examination, vital signs and laboratory test results will be collected from 28 days prior to and out to a 35 day window after Fluciclovine 18F (FACBC) administration.
The major goals of the investigation are to consolidate the safety profile of Fluciclovine 18F (FACBC), to evaluate its use in the detection of local and extraprostatic recurrence of prostate cancer and to evaluate its ability to detect malignancy in patients undergoing screening for primary prostate cancer.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluciclovine (18F) | Radiation | Not applicable. This is an observational study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events | Treatment-emergent Adverse Events and Treatment-Emergent Serious Adverse Events | Up to 35 days post Fluciclovine 18F |
| Positive Predictive Value of FACBC Compared to Histology to Detect Recurrence in Patients Previously Diagnosed With Prostate Cancer | Positive Predictive Value is the percentage of participants with a positive Fluciclovine 18F scan who truly have positive finding in biopsy. | Up to 1 year post Fluciclovine 18F |
| Positive Predictive Value of FACBC to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer | Positive Predictive Value is the percentage of participants with a positive Fluciclovine 18F scan who truly have positive finding in biopsy. | Up to 1 year post Fluciclovine 18F |
| Measure | Description | Time Frame |
|---|---|---|
| Detection Rate, Sensitivity, Specificity, and Negative Predictive Value in Biochemically Recurrent Prostate Cancer | Detection rate is the percentage of participants with positive finding in Fluciclovine 18F scan. Sensitivity is the percentage of participants with positive finding in biopsy correctly identified as positive by Fluciclovine 18F scan. Specificity is the percentage of participants with negative finding in biopsy correctly identified as negative by Fluciclovine 18F scan. Negative Predictive Value is the percentage of participants with a negative Fluciclovine 18F scan who truly don't have positive finding in biopsy. |
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Inclusion Criteria:
Exclusion Criteria:
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All patients (male/female) who underwent PET scanning using fluciclovine (18F) as the radiotracer for the detection of cancer at a clinical site participating in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Penelope Ward, MBBS FFPM | Blue Earth Diagnostics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital | Atlanta | Georgia | 30322 | United States | ||
| University Hospital Sant'Orsola Malpighi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27746282 | Result | Bach-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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Recurrent Prostate Cancer | Recurrent Prostate Cancer |
| FG001 | Primary Prostate Cancer | Primary Prostate Cancer |
| FG002 | Other Cancers | Other Cancers |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Recurrent Prostate Cancer | Recurrent Prostate Cancer |
| BG001 | Primary Prostate Cancer | Primary Prostate Cancer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events | Treatment-emergent Adverse Events and Treatment-Emergent Serious Adverse Events | Patients who have received at least one dose of Fluciclovine 18F | Posted | Count of Participants | Participants | Up to 35 days post Fluciclovine 18F |
|
All Treatment Emergent Adverse Events (TEAEs) occurring up to 35 days after each 18F-fluciclovine administration, and for all TEAEs occurring between two consecutive administrations of 18F and up to 35 days after the last 18F administration.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 18F-Fluciclovine PET | 18F-Fluciclovine PET | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site extravasation | General disorders | MedDRA (17.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Blue Earth Diagnostics Ltd. | +44 (0) 1865 784 186 | contact@blueearthdx.com |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C117460 | fluciclovine F-18 |
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| Up to 1 year post Fluciclovine 18F |
| Detection Rate, Sensitivity, Specificity, and Negative Predictive Value to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer | Detection rate is the percentage of participants with positive finding in Fluciclovine 18F scan. Sensitivity is the percentage of participants with positive finding in biopsy correctly identified as positive by Fluciclovine 18F scan. Specificity is the percentage of participants with negative finding in biopsy correctly identified as negative by Fluciclovine 18F scan. Negative Predictive Value is the percentage of participants with a negative Fluciclovine 18F scan who truly don't have positive finding in biopsy. | Up to 1 year post Fluciclovine 18F |
| Bologna |
| 40138 |
| Italy |
| Oslo University Hospital | Oslo | 0424 | Norway |
| Aleris Kreftsenter | Oslo | N-0264 | Norway |
| BG002 |
| Other Cancers |
Other Cancers |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Other Cancers |
|
|
| Primary | Positive Predictive Value of FACBC Compared to Histology to Detect Recurrence in Patients Previously Diagnosed With Prostate Cancer | Positive Predictive Value is the percentage of participants with a positive Fluciclovine 18F scan who truly have positive finding in biopsy. | Standard of truth was histology. For the prostate/bed region standard TRUS/biopsy or MRI/TRUS fusion biopsy was used to establish truth while blinded to PET findings. When feasible, clinically relevant 18F-fluciclovine positive extraprostatic areas underwent directed biopsy based on cognitive fusion of the PET/CT data with biopsy technique. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 1 year post Fluciclovine 18F |
|
|
|
| Primary | Positive Predictive Value of FACBC to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer | Positive Predictive Value is the percentage of participants with a positive Fluciclovine 18F scan who truly have positive finding in biopsy. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 1 year post Fluciclovine 18F |
|
|
|
| Secondary | Detection Rate, Sensitivity, Specificity, and Negative Predictive Value in Biochemically Recurrent Prostate Cancer | Detection rate is the percentage of participants with positive finding in Fluciclovine 18F scan. Sensitivity is the percentage of participants with positive finding in biopsy correctly identified as positive by Fluciclovine 18F scan. Specificity is the percentage of participants with negative finding in biopsy correctly identified as negative by Fluciclovine 18F scan. Negative Predictive Value is the percentage of participants with a negative Fluciclovine 18F scan who truly don't have positive finding in biopsy. | Posted | Number | 95% Confidence Interval | Percentages | Up to 1 year post Fluciclovine 18F |
|
|
|
| Secondary | Detection Rate, Sensitivity, Specificity, and Negative Predictive Value to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer | Detection rate is the percentage of participants with positive finding in Fluciclovine 18F scan. Sensitivity is the percentage of participants with positive finding in biopsy correctly identified as positive by Fluciclovine 18F scan. Specificity is the percentage of participants with negative finding in biopsy correctly identified as negative by Fluciclovine 18F scan. Negative Predictive Value is the percentage of participants with a negative Fluciclovine 18F scan who truly don't have positive finding in biopsy. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 1 year post Fluciclovine 18F |
|
|
|
| 714 |
| 2 |
| 714 |
| 9 |
| 714 |
| Post Procedural Pulmonary Embolism | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Blood Pressure Decreased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
|
| Prostate & Prostate Bed Region PPV |
|
|
| Title | Measurements |
|---|---|
|
| Negative Predictive Value |
|