Whole Body Fluorine F 18 Sodium Fluoride PET/CT Scan and Whole Body MRI in Finding Bone Metastases in Patients With Prostate Cancer
This study has been completed.
Sponsor:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00956163
First received: August 7, 2009
Last updated: July 1, 2014
Last verified: December 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bone Metastases Recurrent Prostate Cancer Stage I Prostate Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer Stage III Prostate Cancer Stage IV Prostate Cancer |
Procedure: magnetic resonance imaging Radiation: fluorine F 18 sodium fluoride Procedure: positron emission tomography Procedure: computed tomography Radiation: technetium Tc 99m methylene diphosphonate Other: laboratory biomarker analysis |
Early Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | F-18 NaF PET for Detection of Bone Metastases in Men With Prostate Cancer: Exploratory Study |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Uptake of fluorine F 18 sodium fluoride on PET/CT scan [ Time Frame: Up to 24 months ]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.
- Incidence of focal MRI abnormality [ Time Frame: Up to 24 months ]Determine if focal MRI abnormality is directly correlated to the metastatic tumor burden within the bones using bone scan as the reference standard.
| Enrollment: | 50 |
| Study Start Date: | March 2010 |
| Study Completion Date: | May 2014 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Diagnostic (fluorine F 18 sodium fluoride PET)
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.
|
Procedure: magnetic resonance imaging
Undergo whole-body MRI
Other Names:
Radiation: fluorine F 18 sodium fluoride
Undergo fluorine F 18 sodium fluoride PET/CT scan
Other Names:
Procedure: positron emission tomography
Undergo fluorine F 18 sodium fluoride PET/CT scan
Other Names:
Procedure: computed tomography
Undergo fluorine F 18 sodium fluoride PET/CT scan
Other Name: tomography, computed
Radiation: technetium Tc 99m methylene diphosphonate
Undergo technetium Tc 99m methylene diphosphonate bone scan
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Any ethnic group
- Pathologically proven prostate cancer with high risk for bone metastases
- Rising prostate-specific antigen (PSA) despite androgen deprivation therapy (ADT), PSA > 10 ng/mL
- Ability to understand and the willingness to sign a written combined Health Insurance Portability and Accountability Act (HIPAA) and informed consent document
- Patients Eastern Cooperative Oncology Group (ECOG) performance is =< 1
Exclusion Criteria:
- Patients may not receive any other investigational therapeutic agents from within 7 days prior to study drug administration through 7 days following study drug administration
- Patients with known contraindications to MR imaging such as presence of MRI incompatible devices such as pacemakers and certain aneurysm clips, severe claustrophobia, or any other condition which would preclude proximity to a strong magnetic field; this exclusion is a standard of practice
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; patients in this category are excluded to reduce medical risk to their safety and to avoid confounding variables in regard to the possibility of adverse events
- Patient is unable to tolerate or has a lifer threatening allergy to the radiopharmaceutical used for bone scan or 18F-fluoride PET
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00956163
Please refer to this study by its ClinicalTrials.gov identifier: NCT00956163
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114 | |
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Mukesh Harisinghani | Massachusetts General Hospital |
More Information
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00956163 History of Changes |
| Other Study ID Numbers: |
NCI-2011-02972 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 ( US NIH Grant/Contract Award Number ) N01CM37120 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | August 7, 2009 |
| Last Updated: | July 1, 2014 |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Neoplasm Metastasis Bone Neoplasms Bone Marrow Diseases Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Neoplastic Processes Pathologic Processes Bone Diseases Musculoskeletal Diseases Hematologic Diseases |
Sodium Fluoride Fluorides Listerine Technetium Tc 99m Medronate Methylene diphosphonate Diphosphonates Cariostatic Agents Protective Agents Physiological Effects of Drugs Anti-Infective Agents, Local Anti-Infective Agents Radiopharmaceuticals Molecular Mechanisms of Pharmacological Action Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 22, 2017