| ID | Type | Description | Link |
|---|---|---|---|
| 08-C-0226 |
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Background:
Objectives:
Eligibility:
Design:
Background:
Objectives:
Primary Objective:
- To compare the biodistribution of (11C) acetate ((11C)AC) PET/CT imaging in tumor and non-tumorous regions of the prostate in patients with known prostate cancer.
Secondary Objective:
Eligibility:
Design:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 11C-acetate for Prostate Cancer Patients | Experimental | 11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (C-11 Acetate) | Drug | 11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare the Biodistribution of 11C-acetate Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging in Tumor and Non Tumorous Regions of the Prostate | Standard uptake values (SUV) measurements of 11C-acetate will be obtained in each sextant (e.g. region) on each patient. Sextant-specific malignancy will be determined pathologically based on a subsequent prostatectomy. Initially, on each patient, we will, average SUV measurements in tumor and non-tumor regions (i.e., sextants with malignancy and no malignancy, respectively). The patient average SUV measurements across tumors and non-tumor regions will then be compared using a paired t-test. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Count of Participants With Adverse Events | Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. | 2 years |
| Diagnostic Accuracy of the Standardized Uptake Value of [11C]AC Obtained Using Positron Emission Tomography (PET)/Computed Tomography (CT) for Detecting Region (Sextant)-Specific Malignancy Using Receiver Operating Curves (ROC) for a Lesion >0.9cm |
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EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Peter L Choyke, M.D. | National Cancer Institute, National Institutes of Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12679398 | Background | Oyama N, Miller TR, Dehdashti F, Siegel BA, Fischer KC, Michalski JM, Kibel AS, Andriole GL, Picus J, Welch MJ. 11C-acetate PET imaging of prostate cancer: detection of recurrent disease at PSA relapse. J Nucl Med. 2003 Apr;44(4):549-55. | |
| 15564406 | Background | Jung JA, Coakley FV, Vigneron DB, Swanson MG, Qayyum A, Weinberg V, Jones KD, Carroll PR, Kurhanewicz J. Prostate depiction at endorectal MR spectroscopic imaging: investigation of a standardized evaluation system. Radiology. 2004 Dec;233(3):701-8. doi: 10.1148/radiol.2333030672. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 11C-acetate for Prostate Cancer Patients | 11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 11C-acetate for Prostate Cancer Patients | 11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Compare the Biodistribution of 11C-acetate Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging in Tumor and Non Tumorous Regions of the Prostate | Standard uptake values (SUV) measurements of 11C-acetate will be obtained in each sextant (e.g. region) on each patient. Sextant-specific malignancy will be determined pathologically based on a subsequent prostatectomy. Initially, on each patient, we will, average SUV measurements in tumor and non-tumor regions (i.e., sextants with malignancy and no malignancy, respectively). The patient average SUV measurements across tumors and non-tumor regions will then be compared using a paired t-test. | One patient was not imaged because of failed tracer synthesis. | Posted | Mean | Standard Deviation | ng/mL | 2 years |
|
2 years
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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 | 11C-acetate for Prostate Cancer Patients | 11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constitutional Symptoms-Other (Specify, Funny smell) | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter L. Choyke | National Cancer Institute, National Institutes of Health | 301-402-8409 | pchoyke@mail.nih.gov |
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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 |
|---|---|
| C438206 | carbon-11 acetate |
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The diagnostic accuracy of 11C-Acetate PET/CT imaging in prostate cancer was compared with multi-parametric magnetic resonance imaging (MP-MRI) using sector based analysis, generating receiver-operating-characteristic (ROC) curves (plots of 1-specificity versus sensitivity) for both modalities. |
| 2 years |
| Pelvic Biodistribution of [11C]AC Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging | Pelvic biodistribution was obtained for the prostate tumor, normal prostate and benign prostatic hyperplasia (BPH). Uptake is expressed in standardized uptake value (SUV). | 2 years |
| Count of Participants With Physiological Effects of [11C]AC | Buildup of positron emission tomography (PET) radiopharmaceuticals excreted by the urinary system can accumulate in the bladder and limit pelvic imaging. This effect contributes to low physiologic distribution in the pelvis. | 2 years |
| Incidence of Extraprostatic Lesions Accumulating [11C]AC Positron Emission Tomography (PET)/Computed Tomography (CT) Detection | Suspicious lesions noted on biopsy were compared with standard care imaging diagnostic modalities, additional biopsies, and/or clinical follow up performed at the discretion of the referring physician. | 2 years |
| Standardized Uptake Value (SUV) of Grouping Tumors Based on Gleason Score | Intensity [11C]AC uptake with histopathologic Gleason grade were done with a Spearman rank correlation following prostatectomy. Two biopsies were performed and graded according to tumor pattern. The two grades were added together for a final Gleason score. Gleason score equal to or less than 3+4 is considered low risk. Gleason score equal to or greater than 4+3 is considered high-risk. | 2 years |
| Lesion Based Sensitivity Analysis Using Positron Emission Tomography (PET)/Computed Tomography (CT), Multi-parametric Magnetic Resonance Imaging (MP-MRI), Diffusion Weighted-Magnetic Resonance Imaging (DW-MRI), and DCE-MRI. | PET/CT, MP-MRI, DW-MRI, and dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) were used to detect lesion sensitivity. | 2 years |
| 11C-Acetate Standardized Uptake Value (SUV)Max and Serum Prostate Specific Antigen (PSA) Levels Using Spearman Correlation | Tumor foci was histopathologically identified and tested to determine SUVmax relative to PSA levels. PSA normal range is 0-4ng/mL. | 2 years |
| 22343504 | Result | Mena E, Turkbey B, Mani H, Adler S, Valera VA, Bernardo M, Shah V, Pohida T, McKinney Y, Kwarteng G, Daar D, Lindenberg ML, Eclarinal P, Wade R, Linehan WM, Merino MJ, Pinto PA, Choyke PL, Kurdziel KA. 11C-Acetate PET/CT in localized prostate cancer: a study with MRI and histopathologic correlation. J Nucl Med. 2012 Apr;53(4):538-45. doi: 10.2967/jnumed.111.096032. Epub 2012 Feb 17. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Interval Between Magnetic Resonance Imaging and Prostatectomy | Prostatectomy is a partial or total removal of the prostate gland. | One patient was not imaged due to failed tracer synthesis. One patient was not evaluable due to inadequate registration between the transmission scan and magnetic resonance imaging. | Mean | Full Range | Days |
|
| Days to Radical Prostatectomy | Radical prostatectomy is removal of the entire prostate gland. and additional tissue | One patient was not imaged due to failed tracer synthesis. One patient was not evaluable due to inadequate registration between the transmission scan and magnetic resonance imaging. | Mean | Full Range | Days |
|
|
|
| Secondary | Count of Participants With Adverse Events | Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Secondary | Diagnostic Accuracy of the Standardized Uptake Value of [11C]AC Obtained Using Positron Emission Tomography (PET)/Computed Tomography (CT) for Detecting Region (Sextant)-Specific Malignancy Using Receiver Operating Curves (ROC) for a Lesion >0.9cm | The diagnostic accuracy of 11C-Acetate PET/CT imaging in prostate cancer was compared with multi-parametric magnetic resonance imaging (MP-MRI) using sector based analysis, generating receiver-operating-characteristic (ROC) curves (plots of 1-specificity versus sensitivity) for both modalities. | One patient was not imaged because of failed tracer synthesis. | Posted | Number | 95% Confidence Interval | Percentage ROC curve | 2 years |
|
|
|
| Secondary | Pelvic Biodistribution of [11C]AC Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging | Pelvic biodistribution was obtained for the prostate tumor, normal prostate and benign prostatic hyperplasia (BPH). Uptake is expressed in standardized uptake value (SUV). | One patient was not imaged because of failed tracer synthesis. | Posted | Mean | Standard Deviation | SUV | 2 years |
|
|
|
|
| Secondary | Count of Participants With Physiological Effects of [11C]AC | Buildup of positron emission tomography (PET) radiopharmaceuticals excreted by the urinary system can accumulate in the bladder and limit pelvic imaging. This effect contributes to low physiologic distribution in the pelvis. | One patient was not imaged because of failed tracer synthesis. | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Secondary | Incidence of Extraprostatic Lesions Accumulating [11C]AC Positron Emission Tomography (PET)/Computed Tomography (CT) Detection | Suspicious lesions noted on biopsy were compared with standard care imaging diagnostic modalities, additional biopsies, and/or clinical follow up performed at the discretion of the referring physician. | One patient was not imaged because of failed tracer synthesis. | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Secondary | Standardized Uptake Value (SUV) of Grouping Tumors Based on Gleason Score | Intensity [11C]AC uptake with histopathologic Gleason grade were done with a Spearman rank correlation following prostatectomy. Two biopsies were performed and graded according to tumor pattern. The two grades were added together for a final Gleason score. Gleason score equal to or less than 3+4 is considered low risk. Gleason score equal to or greater than 4+3 is considered high-risk. | One patient was not imaged because of failed tracer synthesis. | Posted | Mean | Standard Deviation | SUV | 2 years |
|
|
|
|
| Secondary | Lesion Based Sensitivity Analysis Using Positron Emission Tomography (PET)/Computed Tomography (CT), Multi-parametric Magnetic Resonance Imaging (MP-MRI), Diffusion Weighted-Magnetic Resonance Imaging (DW-MRI), and DCE-MRI. | PET/CT, MP-MRI, DW-MRI, and dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) were used to detect lesion sensitivity. | One patient was not imaged because of failed tracer synthesis. | Posted | Number | 95% Confidence Interval | percentage of sensitivity | 2 years |
|
|
|
| Secondary | 11C-Acetate Standardized Uptake Value (SUV)Max and Serum Prostate Specific Antigen (PSA) Levels Using Spearman Correlation | Tumor foci was histopathologically identified and tested to determine SUVmax relative to PSA levels. PSA normal range is 0-4ng/mL. | One patient was not imaged because of failed tracer synthesis. | Posted | Mean | Standard Deviation | SUVmax | 2 years |
|
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 14 |
| 40 |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Taste alteration (dysgeusia) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Syncope (fainting) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Pain: Back | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain: Extremity-limb | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Title | Measurements |
|---|---|
|
| MRI specificity |
|
| Title | Measurements |
|---|---|
|
| 0.65 |
The reported p-value is representative of the BPH high uptake level. |
| Superiority |
| Title | Measurements |
|---|---|
|
| DCE-MRI |
|
| Title | Measurements |
|---|---|
|