Combined 18F-NaF/18F-FDG PET/MRI for Detection of Skeletal Metastases
NCT ID: NCT00375830
Last Updated: 2023-12-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
114 participants
INTERVENTIONAL
2006-01-31
2019-03-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
18F-NaF and 18F-FDG are radioactive substances (radiolabels) that are absorbed by cancerous cells and allow for the cancer to be found using diagnostic procedures such as positron emission tomography (PET)/ whole body magnetic resonance imaging (WBMRI). PET/WBMRI is a combination procedure that combines the detailed PET images of areas inside the body from PET with the WBMRI scans, and may help find and diagnose skeletal metastases in patients with breast or prostate cancer. It is not yet known whether 18F-NaF/18F-FDG PET/WBMRI is better than standard imaging methods in detecting skeletal metastases.
Eligible participants diagnosed with breast/prostate cancers and who have had 99mTc MDP bone scanning as part of their routine care are recruited and enrolled. Participants then receive an 18F-NaF/18F-FDG positron emission tomography (PET)/ WBMRI combination scan.
The PET/MRI scans will be interpreted by 2 American Board Nuclear Medicine (ABNM)-certified physicians and 2 American Board of Radiology (ABR)-certified radiologists, all with significant clinical experience, who are blinded to the subjects' medical history and the results of other imaging modalities.
The scans will be analyzed and compared against each other, with a consensus read will be obtained for each scan. Characterization of lesions as true-positive, true-negative, false-positive or false-negative will be done through a combination of clinical follow-up, imaging follow-up and/or histopathology findings. An overall diagnosis based on each scan will be determined on a 5-point scale (1=benign, 2=likely benign, 3=uncertain, 4=likely malignant, 5=malignant) to conduct a receiver operating characteristic (ROC) analysis.
If the diagnosis is positive for metastases on any of the scans, the investigator will identify the number of lesions and locations of positivity, and record this information.
Clinical is obtained at about 12 months after the initial scans.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans
Preliminary pilot assessment to confirm feasibility \& improved diagnostic accuracy of the combined 18F-NaF CT \& 18F-FDG PET scan procedures, as compared to the regular medical care procedure, 99mTc MDP bone scans.
Bone scan
Scan to diagnose a number of bone conditions including cancer or metastasis
99mTc-methyl diphosphonate
Radiolabel for bone scan procedures
Positron Emission Tomography (PET) scan
Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG)
Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan
Scan to detect \& analyze X-rays
18F-Sodium Fluoride (18F-NaF)
Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.
Gadopentetate dimeglumine
A gadolinium-based contrast agent for MRI
Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans
Assessment to define the accuracy of the combined 18F-NaF CT \& 18F-FDG PET/CT scan procedures compared to 99mTc MDP bone scan.
Bone scan
Scan to diagnose a number of bone conditions including cancer or metastasis
99mTc-methyl diphosphonate
Radiolabel for bone scan procedures
Positron Emission Tomography (PET) scan
Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG)
Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan
Scan to detect \& analyze X-rays
18F-Sodium Fluoride (18F-NaF)
Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.
Whole Body Magnetic Resonance Imaging (WB-MRI) scan
Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Scan that uses strong magnetic fields \& radio waves to generate images of the organs in the body.
Gadofosveset
A gadolinium-based contrast agent for MRI
Gadobutrol
A gadolinium-based contrast agent for MRI
Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI scan
Assessment to define the utility of 18F-NaF \& 18F-FDG as the radiolabels in a single combined PET / WB-MRI procedure.
Bone scan
Scan to diagnose a number of bone conditions including cancer or metastasis
99mTc-methyl diphosphonate
Radiolabel for bone scan procedures
Positron Emission Tomography (PET) scan
Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG)
Radiolabel for positron emission tomography scan procedures
18F-Sodium Fluoride (18F-NaF)
Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.
Whole Body Magnetic Resonance Imaging (WB-MRI) scan
Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Scan that uses strong magnetic fields \& radio waves to generate images of the organs in the body.
Gadofosveset
A gadolinium-based contrast agent for MRI
Gadobutrol
A gadolinium-based contrast agent for MRI
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bone scan
Scan to diagnose a number of bone conditions including cancer or metastasis
99mTc-methyl diphosphonate
Radiolabel for bone scan procedures
Positron Emission Tomography (PET) scan
Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG)
Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan
Scan to detect \& analyze X-rays
18F-Sodium Fluoride (18F-NaF)
Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.
Whole Body Magnetic Resonance Imaging (WB-MRI) scan
Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Scan that uses strong magnetic fields \& radio waves to generate images of the organs in the body.
Gadopentetate dimeglumine
A gadolinium-based contrast agent for MRI
Gadofosveset
A gadolinium-based contrast agent for MRI
Gadobutrol
A gadolinium-based contrast agent for MRI
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* ≥ Stage 3 breast cancer OR ≥ stage 2 prostate cancer OR prostate-specific antigen (PSA) \> 10 micrograms/L OR recurrent breast or prostate cancer
* Capable of complying with study procedures
* Able to remain still for duration of imaging procedure (about one hour)
* Written informed consent
Exclusion Criteria
* Metallic implants that contraindicate MRI
* Renal function impairment that contraindicates MRI
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Stanford University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Andrei Iagaru
Professor of Radiology (Nuclear Medicine)
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andrei Iagaru, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stanford University School of Medicine
Stanford, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Iagaru A, Young P, Mittra E, Dick DW, Herfkens R, Gambhir SS. Pilot prospective evaluation of 99mTc-MDP scintigraphy, 18F NaF PET/CT, 18F FDG PET/CT and whole-body MRI for detection of skeletal metastases. Clin Nucl Med. 2013 Jul;38(7):e290-6. doi: 10.1097/RLU.0b013e3182815f64.
Minamimoto R, Loening A, Jamali M, Barkhodari A, Mosci C, Jackson T, Obara P, Taviani V, Gambhir SS, Vasanawala S, Iagaru A. Prospective Comparison of 99mTc-MDP Scintigraphy, Combined 18F-NaF and 18F-FDG PET/CT, and Whole-Body MRI in Patients with Breast and Prostate Cancer. J Nucl Med. 2015 Dec;56(12):1862-8. doi: 10.2967/jnumed.115.162610. Epub 2015 Sep 24.
Iagaru A, Minamimoto R, Jamali M, Barkodhodari A, Gambhir SS, Vasanawala S. Imaging patients with breast and prostate cancers using combined 18F NaF/18F FDG and TOF simultaneous PET/ MRI. EJNMMI Phys. 2015 Dec;2(Suppl 1):A65. doi: 10.1186/2197-7364-2-S1-A65. No abstract available.
Sonni I, Minamimoto R, Baratto L, Gambhir SS, Loening AM, Vasanawala SS, Iagaru A. Simultaneous PET/MRI in the Evaluation of Breast and Prostate Cancer Using Combined Na[18F] F and [18F]FDG: a Focus on Skeletal Lesions. Mol Imaging Biol. 2020 Apr;22(2):397-406. doi: 10.1007/s11307-019-01392-9.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
96754
Identifier Type: OTHER
Identifier Source: secondary_id
BONE0001
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-03778
Identifier Type: -
Identifier Source: org_study_id