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Combined 18F-NaF/18F-FDG PET/MRI for Detection of Skeletal Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00375830
Recruitment Status : Completed
First Posted : September 13, 2006
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Stanford University

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.

Condition or disease Intervention/treatment Phase
Cancer Procedure: Bone scan Drug: 99mTc-methyl diphosphonate (99mTc-MDP; t99-MDP) Procedure: Positron Emission Tomography (PET) scan Drug: 18F-Fludeoxyglucose (18F-FDG) Procedure: Computed Tomography (CT) scan Drug: 18F-Sodium Fluoride (18F-NaF) Procedure: Whole Body Magnetic Resonance Imaging (WB-MRI) scan Drug: Gadopentetate dimeglumine Drug: Gadofosveset Drug: Gadobutrol Phase 2

Detailed Description:

Eligible participants had previously received a bone scan using the radiolabel 99mTc-methyl diphosphonate (t99-MDP) as part of their regular medical care.

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 recieve 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Combined 18F-NaF/18F-FDG PET/MRI for Detection of Skeletal Metastases
Actual Study Start Date : January 2006
Actual Primary Completion Date : April 17, 2017
Actual Study Completion Date : March 14, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans
Preliminary pilot assessment to confirm feasibility and improved diagnostic accuracy of the combined sodium fluorine-18 (18F-NaF) computed tomography (CT) and fluorine-18 (18F) fluorodeoxyglucose (FDG, 18F-FDG) positron emission tomography (PET) scan procedures, as compared to the regular medical care procedure, 99mTc MDP bone scans.
Procedure: Bone scan
A medical imaging scan useful to diagnose a number of bone conditions, including cancer or metastasis, infection, inflammation, and/or fractures
Other Name: Bone scintigraphy

Drug: 99mTc-methyl diphosphonate (99mTc-MDP; t99-MDP)
Radiolabel for bone scan procedures
Other Names:
  • 99mTc-methylene diphosphonate
  • Technetium 99mTc medronate

Procedure: Positron Emission Tomography (PET) scan
A medical imaging scan that is either a "stand alone" scan, or as part of a PET/MRI or PET/CT procedure that detects gamma rays emitted by a positron-emitting radioligand such as fluorine-18 (18F).

Drug: 18F-Fludeoxyglucose (18F-FDG)
Radiolabel for positron emission tomography (PET) scan procedures
Other Names:
  • 2-Deoxy-2-(18F)Fluoro-D-Glucose
  • 2-F18-Fluoro-2-deoxy-D-glucose
  • 2-F18-Fluoro-2-deoxyglucose
  • 18F 2-Fluoro-2-deoxy-D-Glucose
  • Fludeoxyglucose F-18
  • Fluorodeoxyglucose F18

Procedure: Computed Tomography (CT) scan
A medical imaging scan based on detection and computerized analysis of X-rays after the X-rays pass through tissue
Other Names:
  • Computerized Axial Tomograph (CAT) scan
  • Computer-aided Tomography (CAT) scan

Drug: 18F-Sodium Fluoride (18F-NaF)
Radiolabel for computed tomography (CT) and positron emission tomography (PET) scan procedures, and as a contrast agent for magnetic resonance imaging (MRI) scan procedures.
Other Name: 18F-Sodium Fluorine

Drug: Gadopentetate dimeglumine
A gadolinium-based contrast agent for magnetic resonance imaging (MRI), including whole body MRI (WB-MRI)
Other Name: Magnevist

Experimental: Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans
Assessment to confirm and defined the improved diagnostic accuracy of the combined sodium fluorine-18 (18F-NaF) computed tomography (CT) and fluorine-18 (18F) fluorodeoxyglucose (FDG, 18F-FDG) positron emission tomography (PET) scan procedures over the regular medical care procedure, 99mTc MDP bone scan.
Procedure: Bone scan
A medical imaging scan useful to diagnose a number of bone conditions, including cancer or metastasis, infection, inflammation, and/or fractures
Other Name: Bone scintigraphy

Drug: 99mTc-methyl diphosphonate (99mTc-MDP; t99-MDP)
Radiolabel for bone scan procedures
Other Names:
  • 99mTc-methylene diphosphonate
  • Technetium 99mTc medronate

Procedure: Positron Emission Tomography (PET) scan
A medical imaging scan that is either a "stand alone" scan, or as part of a PET/MRI or PET/CT procedure that detects gamma rays emitted by a positron-emitting radioligand such as fluorine-18 (18F).

Drug: 18F-Fludeoxyglucose (18F-FDG)
Radiolabel for positron emission tomography (PET) scan procedures
Other Names:
  • 2-Deoxy-2-(18F)Fluoro-D-Glucose
  • 2-F18-Fluoro-2-deoxy-D-glucose
  • 2-F18-Fluoro-2-deoxyglucose
  • 18F 2-Fluoro-2-deoxy-D-Glucose
  • Fludeoxyglucose F-18
  • Fluorodeoxyglucose F18

Procedure: Computed Tomography (CT) scan
A medical imaging scan based on detection and computerized analysis of X-rays after the X-rays pass through tissue
Other Names:
  • Computerized Axial Tomograph (CAT) scan
  • Computer-aided Tomography (CAT) scan

Drug: 18F-Sodium Fluoride (18F-NaF)
Radiolabel for computed tomography (CT) and positron emission tomography (PET) scan procedures, and as a contrast agent for magnetic resonance imaging (MRI) scan procedures.
Other Name: 18F-Sodium Fluorine

Procedure: Whole Body Magnetic Resonance Imaging (WB-MRI) scan
A non-radiological medical imaging scan that uses strong magnetic fields, magnetic field gradients, and radio waves to generate images of the organs in the body. Scan quality is usually enhanced by the use of a gadolinium-based contrast agent.

Drug: Gadofosveset
A gadolinium-based contrast agent for magnetic resonance imaging (MRI), including whole body MRI (WB-MRI)
Other Name: Ablavar

Drug: Gadobutrol
A gadolinium-based contrast agent for magnetic resonance imaging (MRI), including whole body MRI (WB-MRI)
Other Name: Gadavist

Experimental: Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI scan
Assessment to define the utility of sodium fluorine-18 (18F-NaF) and fluorine-18 (18F) fluorodeoxyglucose (FDG, 18F-FDG) as the radiolabels in a single combined positron emission tomography (PET)/whole body magnetic resonance imaging (WB-MRI) procedure. The computed tomography (CT) scan, a scan based on ionizing radiation, is omitted.
Procedure: Bone scan
A medical imaging scan useful to diagnose a number of bone conditions, including cancer or metastasis, infection, inflammation, and/or fractures
Other Name: Bone scintigraphy

Drug: 99mTc-methyl diphosphonate (99mTc-MDP; t99-MDP)
Radiolabel for bone scan procedures
Other Names:
  • 99mTc-methylene diphosphonate
  • Technetium 99mTc medronate

Procedure: Positron Emission Tomography (PET) scan
A medical imaging scan that is either a "stand alone" scan, or as part of a PET/MRI or PET/CT procedure that detects gamma rays emitted by a positron-emitting radioligand such as fluorine-18 (18F).

Drug: 18F-Fludeoxyglucose (18F-FDG)
Radiolabel for positron emission tomography (PET) scan procedures
Other Names:
  • 2-Deoxy-2-(18F)Fluoro-D-Glucose
  • 2-F18-Fluoro-2-deoxy-D-glucose
  • 2-F18-Fluoro-2-deoxyglucose
  • 18F 2-Fluoro-2-deoxy-D-Glucose
  • Fludeoxyglucose F-18
  • Fluorodeoxyglucose F18

Drug: 18F-Sodium Fluoride (18F-NaF)
Radiolabel for computed tomography (CT) and positron emission tomography (PET) scan procedures, and as a contrast agent for magnetic resonance imaging (MRI) scan procedures.
Other Name: 18F-Sodium Fluorine

Procedure: Whole Body Magnetic Resonance Imaging (WB-MRI) scan
A non-radiological medical imaging scan that uses strong magnetic fields, magnetic field gradients, and radio waves to generate images of the organs in the body. Scan quality is usually enhanced by the use of a gadolinium-based contrast agent.

Drug: Gadofosveset
A gadolinium-based contrast agent for magnetic resonance imaging (MRI), including whole body MRI (WB-MRI)
Other Name: Ablavar

Drug: Gadobutrol
A gadolinium-based contrast agent for magnetic resonance imaging (MRI), including whole body MRI (WB-MRI)
Other Name: Gadavist




Primary Outcome Measures :
  1. Concordance between 99mTc MDP bone scan and 18F NaF/18F FDG PET/MRI as the proportion of patients where the modalities agree [ Time Frame: 12 months ]
    Calculate the concordance between the modalities across outcomes (combining cases and controls) and evaluate the results by calculating the kappa coefficient.


Secondary Outcome Measures :
  1. Concordance in cases and controls, sensitivity, specificity, positive predicted value, and negative predictive value (per patient) [ Time Frame: 12 months ]
    Calculated both as aggregates of the 3diseases and separately by disease. Sensitivities and other summaries will only be calculated if they involve a denominator of at least 10.

  2. Distribution of lesions seen on each modality (per lesion) [ Time Frame: 12 months ]
    Calculated both as aggregates of the 3diseases and separately by disease. Sensitivities and other summaries will only be calculated if they involve a denominator of at least 10.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

All patients were enrolled after recieving a regular medical care bone scan using the radiolabel 99mTc-methyl diphosphonate (t99-MDP).

INCLUSION CRITERIA

  • ≥ 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

EXCLUSION CRITERIA

  • Pregnant or nursing
  • Metallic implants that contraindicate MRI
  • Renal function impairment that contraindicates MRI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00375830


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Andrei Iagaru, MD Stanford University
  Study Documents (Full-Text)

Documents provided by Stanford University:
Informed Consent Form  [PDF] April 26, 2019


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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00375830     History of Changes
Other Study ID Numbers: IRB-03778
96754 ( Other Identifier: Stanford University Alternate IRB Approval Number )
BONE0001 ( Other Identifier: OnCore )
First Posted: September 13, 2006    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Diphosphonates
Methylene diphosphonate
Listerine
Deoxyglucose
Fluorides
Sodium Fluoride
Fluorodeoxyglucose F18
Technetium Tc 99m Medronate
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Bone Density Conservation Agents