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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-02972 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000666327 | |||
| MGH-09364 | |||
| 09-364 | Other Identifier | Massachusetts General Hospital Cancer Center | |
| 8336 | Other Identifier | CTEP | |
| P30CA006516 | U.S. NIH Grant/Contract | View source | |
| N01CM37120 | U.S. NIH Grant/Contract | View source |
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This phase 0 trial studies whole body fluorine F 18 sodium fluoride positron emission tomography (PET)/computed tomography (CT) scan and whole body magnetic resonance imaging (MRI) in finding bone metastases in patients with prostate cancer. Diagnostic procedures, such as whole body fluorine F 18 sodium fluoride PET/CT scan and whole body MRI, may help find and diagnose bone metastases.
PRIMARY OBJECTIVES:
I. To evaluate the sensitivity and specificity of whole-body fluorine F 18 sodium fluoride PET/CT scan in detecting bone metastases in patients with high-risk prostate cancer using bone scan as the reference standard.
II. To evaluate the sensitivity and specificity of whole-body MRI in detecting bone metastases in patients with high-risk prostate cancer using bone scan as the reference standard.
OUTLINE:
Patients undergo technetium Tc 99m methylene diphosphonate bone scan, fluorine F 18 sodium fluoride PET/CT scan, and whole-body MRI for the detection of bone metastases. Patients with discordant imaging results (negative bone scan and positive PET/CT scan and/or MRI) undergo additional imaging at 6, 12, 18, and 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (fluorine F 18 sodium fluoride PET) | Experimental | Patients undergo technetium Tc 99m methylene diphosphonate bone scan, fluorine F 18 sodium fluoride PET/CT scan, and whole-body MRI for the detection of bone metastases. Patients with discordant imaging results (negative bone scan and positive PET/CT scan and/or MRI) undergo additional imaging at 6, 12, 18, and 24 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| magnetic resonance imaging | Procedure | Undergo whole-body MRI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Uptake of fluorine F 18 sodium fluoride on PET/CT scan | Determine if increased uptake of 18F-fluoride on PET/CT scan is directly correlated to the metastatic tumor burden within the bones using bone scan as the reference standard. | Up to 24 months |
| Incidence of focal MRI abnormality | Determine if focal MRI abnormality is directly correlated to the metastatic tumor burden within the bones using bone scan as the reference standard. | Up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mukesh Harisinghani | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
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| fluorine F 18 sodium fluoride | Radiation | Undergo fluorine F 18 sodium fluoride PET/CT scan |
|
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| positron emission tomography | Procedure | Undergo fluorine F 18 sodium fluoride PET/CT scan |
|
|
| computed tomography | Procedure | Undergo fluorine F 18 sodium fluoride PET/CT scan |
|
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| technetium Tc 99m methylene diphosphonate | Radiation | Undergo technetium Tc 99m methylene diphosphonate bone scan |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| C062942 | 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole |
| D013669 | Technetium Tc 99m Medronate |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D015609 | Organotechnetium Compounds |
| D009942 | Organometallic Compounds |
| D009930 | Organic Chemicals |
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
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