Combined 18F-NaF/18F-FDG PET/MRI for Detection of Skeletal Metastases
3 other identifiers
interventional
114
1 country
1
Brief Summary
This clinical trial studies the use of sodium fluorine-18 (18F-NaF) plus fluorine-18 (18F) fluorodeoxyglucose (FDG) positron emission tomography (PET)/ whole body magnetic resonance imaging (WBMRI) to detect skeletal metastases in patients with stage III-IV breast cancer or stage II-IV prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 cancer
Started Jan 2006
Longer than P75 for phase_2 cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 11, 2006
CompletedFirst Posted
Study publicly available on registry
September 13, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 17, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 14, 2019
CompletedResults Posted
Study results publicly available
November 8, 2019
CompletedDecember 12, 2023
November 1, 2023
11.3 years
September 11, 2006
October 19, 2019
November 18, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Cohort 1 - NaF PET/CT vs 99mTc-MDP Bone Scintigraphy
The medical value of 18F-sodium fluoride (NaF) positron emission tomography / computed tomography (PET/CT) vs 99mTc-methylene diphosphonate (MDP) bone scintigraphy was assessed on the basis of the radiation oncologist's medical assessment of image quality and detected extent of disease, for each participant. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom the medical value of the image was superior for 18F-NaF vs 99mTc-MDP bone scintigraphy ("18F-NaF \> 99mTc-MDP"), the same between both scans ("18F-NaF = 99mTc-MDP"), or inferior for 18F-NaF vs 99mTc-MDP bone scintigraphy ("18F-NaF \< 99mTc-MDP").
30 days
Secondary Outcomes (11)
Cohort 1 - 18F-NaF PET/CT vs 18F-FDG PET/CT
30 days
Cohort 1 - Whole-body MRI vs 18F-NaF PET/CT
30 days
Cohort 1 - Whole-body MRI vs 18F-FDG PET/CT
30 days
Cohort 1 - Detection of Osseous (Skeletal) Metastases by 18F-NaF and 18F-FDG PET/CT
30 days
Cohort 2 - 18F-NaF/18F-FDG PET/CT vs Whole-body MRI for Detection of Extraskeletal Lesions
30 days
- +6 more secondary outcomes
Study Arms (3)
Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans
EXPERIMENTALPreliminary 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.
Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans
EXPERIMENTALAssessment to define the accuracy of the combined 18F-NaF CT \& 18F-FDG PET/CT scan procedures compared to 99mTc MDP bone scan.
Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI scan
EXPERIMENTALAssessment to define the utility of 18F-NaF \& 18F-FDG as the radiolabels in a single combined PET / WB-MRI procedure.
Interventions
Scan to diagnose a number of bone conditions including cancer or metastasis
Radiolabel for bone scan procedures
Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
Radiolabel for positron emission tomography scan procedures
Scan to detect \& analyze X-rays
Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.
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.
A gadolinium-based contrast agent for MRI
A gadolinium-based contrast agent for MRI
A gadolinium-based contrast agent for MRI
Eligibility Criteria
You may qualify if:
- ≥ 18 years old at the time of the drug administration
- ≥ 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
You may not qualify if:
- Pregnant or nursing
- Metallic implants that contraindicate MRI
- Renal function impairment that contraindicates MRI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University School of Medicine
Stanford, California, 94305, United States
Related Publications (4)
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.
PMID: 23455520RESULTMinamimoto 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.
PMID: 26405167RESULTIagaru 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.
PMID: 26956325RESULTSonni 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.
PMID: 31236756RESULT
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Andrei Iagaru, Professor of Radiology (Nuclear Medicine)
- Organization
- Stanford University
Study Officials
- PRINCIPAL INVESTIGATOR
Andrei Iagaru, MD
Stanford University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Radiology (Nuclear Medicine)
Study Record Dates
First Submitted
September 11, 2006
First Posted
September 13, 2006
Study Start
January 1, 2006
Primary Completion
April 17, 2017
Study Completion
March 14, 2019
Last Updated
December 12, 2023
Results First Posted
November 8, 2019
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share