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| ID | Type | Description | Link |
|---|---|---|---|
| FACBC | Other Identifier | Other |
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Optimal histolgic verification support such as whole mount analysis could not be made available.
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The purpose of this research project is to test if a compound (chemical substance) has a natural tendency to go to prostate cancer. This compound has a small amount of radioactivity attached to it and is called a radiotracer. The name of the radiotracer is FACBC and can be detected on a special imaging device called a PET scanner (positron emission tomography). The radiotracer is treated in the body much like an amino acid which is a nutrient required for normal functioning. Tumors also use these nutrients. Earlier studies have shown that this radiotracer may be able to detect prostate cancer.
The investigators will perform a study with 20 patients in whom they know have prostate cancer after a biopsy and who are scheduled for an operation in which the prostate is removed and the nearby lymph nodes are examined. This operation is called prostatectomy. The investigators think that this radiotracer can help us determine where exactly the prostate cancer is present in the prostate or if it has spread. This information may be useful in the future to help with other non-surgical therapy such as radiation beam therapy.
The investigators will compare the results of the FACBC PET scan to the results of the pathology analysis of the removed prostate. In this way the investigators can determine how good a test FACBC PET is for finding out where and if prostate cancer is located in the prostate or nearby lymph nodes. The investigators will also do more advanced analysis on the biopsy samples to see if they can tell why FACBC goes into prostate cancer cells.
This radiotracer has been tested in over 100 human subjects without incident. It has also been chosen by the National Institutes of Health (NIH) as a promising radiotracer. The NIH is funding this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FACBC Imaging | Experimental | Dynamic FACBC PET of primary prostate carcinoma. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti [18F]FACBC | Drug | Anti[18F]FACBC (10mci) will be given intravenously over 1-2 minutes prior to obtaining PET-CT images At 4 minutes, 10 consecutive/4minutes images will be obtained of the pelvis to include the prostate. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis | Each of 12 sextants per prostate (for a total of 120 sextants for the 10 patients) were analyzed separately at 4, 16, 28 and 40 min post-injection for the presence or absence of focal activity suspicious for tumor. Sensitivity: Proportion of people with a disease who have a positive test result Specificity: The proportion of people without disease who have a negative test result Positive Predictive Value (PPV):The probability that a person who has a positive test result has the disease for which the test was conducted. Negative Predictive Value (NPV): The probability that a person who has a negative test result does not have the disease for which the test was conducted Accuracy: Ability of the test to differentiate between disease and non-disease. Note: 'n=' is the denominator used to compute each parameter. | At 4, 16, 28 and 40 minutes post-injection of FACBC |
| Measure | Description | Time Frame |
|---|---|---|
| Mean SUVmax of Low Versus High Gleason Groups | To determine id radiotracer uptake correlates with gleason score | 4 minutes,16 minutes,28 minutes and 40 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David M Schuster, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23342303 | Result | Schuster DM, Taleghani PA, Nieh PT, Master VA, Amzat R, Savir-Baruch B, Halkar RK, Fox T, Osunkoya AO, Moreno CS, Nye JA, Yu W, Fei B, Wang Z, Chen Z, Goodman MM. Characterization of primary prostate carcinoma by anti-1-amino-2-[(18)F] -fluorocyclobutane-1-carboxylic acid (anti-3-[(18)F] FACBC) uptake. Am J Nucl Med Mol Imaging. 2013;3(1):85-96. Epub 2013 Jan 5. |
| Label | URL |
|---|---|
| Click here for more information on this study | View source |
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Recruitment period: 5/2008-3/2011. Subjects were referred from physician's offices
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiotracer | [18F] FACBC 10mci injected intravenously prior to PET scan |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiotracer | [18F] FACBC 10mci injected intravenously prior to PET scan |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis | Each of 12 sextants per prostate (for a total of 120 sextants for the 10 patients) were analyzed separately at 4, 16, 28 and 40 min post-injection for the presence or absence of focal activity suspicious for tumor. Sensitivity: Proportion of people with a disease who have a positive test result Specificity: The proportion of people without disease who have a negative test result Positive Predictive Value (PPV):The probability that a person who has a positive test result has the disease for which the test was conducted. Negative Predictive Value (NPV): The probability that a person who has a negative test result does not have the disease for which the test was conducted Accuracy: Ability of the test to differentiate between disease and non-disease. Note: 'n=' is the denominator used to compute each parameter. | The number of participants for analysis was based on the protocol.Each prostate was divided into 12 sextants and then each sextant was visualized for abnormal focal uptake.The SUVmax for the malignant sextants were compared to that of the benign sextants. Note: 'n=' is the denominator used to compute each parameter. | Posted | Number | 95% Confidence Interval | Percentage of Sextants | At 4, 16, 28 and 40 minutes post-injection of FACBC | Sextants | Participants |
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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 | Radiotracer | [18F] FACBC 10mci injected intravenously prior to PET scan |
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A major limitation of our study is lack of step section whole mount histology at our institution which restricted the ability to ensure an exact correlation of histology to imaging.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Schuster, MD | Emory University | 404-712-4859 | dschust@emory.edu |
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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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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Diagnostic Performance Per Sextant at 4mins Post Injection | Each of the 120 sextants was visually analyzed for the presence or absence of tumor. 71 true positive, 7 True negative, 32 false positive and 8 false negative. Because of a technical error, 2 of the 120 sextants were not analysed at this time point. |
| OG001 | Diagnostic Performance Per sextant16mins Post Injetion | At this time point, the 120 sextants analysed were categorized as followed: 68 sextants were seen as true positive, 14 true negative, 25 false positive and 13 false negative |
| OG002 | Diagnostic Performance Per Sextant 28mins Post Injection | At this time point, the 120 sextants analysed were categorized as followed: 65 sextants were seen as true positive, 20 true negative, 20 false positive and 15 false negative |
| OG003 | Diagnostic Performance Per Sextant 40minutes Post Injection | At this time point, the 120 sextants analysed were categorized as followed: 63 sextants were seen as true positive, 15 true negative, 25 false positive and 17 false negative |
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| Secondary | Mean SUVmax of Low Versus High Gleason Groups | To determine id radiotracer uptake correlates with gleason score | Posted | Mean | Standard Deviation | Mean SUV max | 4 minutes,16 minutes,28 minutes and 40 minutes |
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| 0 |
| 11 |
| 0 |
| 11 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| High gleason group |
|