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

Stanford University

Status and phase: Completed; Phase 2

Conditions: Cancer

Treatments: Procedure: Bone scan; Procedure: Whole Body Magnetic Resonance Imaging (WB-MRI) scan; Drug: Gadopentetate dimeglumine; Drug: 18F-Sodium Fluoride (18F-NaF); Drug: 18F-Fludeoxyglucose (18F-FDG); Drug: Gadobutrol; Procedure: Positron Emission Tomography (PET) scan; Drug: Gadofosveset; Drug: 99mTc-methyl diphosphonate; Procedure: Computed Tomography (CT) scan

Study type: Interventional

Funder types: Other

Identifiers

NCT00375830

IRB-03778

BONE0001 (Other Identifier)

96754 (Other Identifier)

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

All patients were enrolled after receiving 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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114 participants in 3 patient groups

Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans

Experimental group

Description:

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.

Treatment:

Drug: 18F-Sodium Fluoride (18F-NaF)

Drug: 99mTc-methyl diphosphonate

Procedure: Positron Emission Tomography (PET) scan

Drug: 18F-Fludeoxyglucose (18F-FDG)

Procedure: Computed Tomography (CT) scan

Drug: Gadopentetate dimeglumine

Procedure: Bone scan

Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans

Experimental group

Description:

Assessment to define the accuracy of the combined 18F-NaF CT \& 18F-FDG PET/CT scan procedures compared to 99mTc MDP bone scan.

Treatment:

Procedure: Whole Body Magnetic Resonance Imaging (WB-MRI) scan

Drug: 18F-Sodium Fluoride (18F-NaF)

Drug: 99mTc-methyl diphosphonate

Drug: Gadofosveset

Procedure: Positron Emission Tomography (PET) scan

Drug: Gadobutrol

Drug: 18F-Fludeoxyglucose (18F-FDG)

Procedure: Computed Tomography (CT) scan

Procedure: Bone scan

Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI scan

Experimental group

Description:

Assessment to define the utility of 18F-NaF \& 18F-FDG as the radiolabels in a single combined PET / WB-MRI procedure.

Treatment:

Procedure: Whole Body Magnetic Resonance Imaging (WB-MRI) scan

Drug: 18F-Sodium Fluoride (18F-NaF)

Drug: 99mTc-methyl diphosphonate

Drug: Gadofosveset

Procedure: Positron Emission Tomography (PET) scan

Drug: Gadobutrol

Drug: 18F-Fludeoxyglucose (18F-FDG)

Procedure: Bone scan