Clinical trial NCT00375830: Combined 18F-NaF/18F-FDG PET/MRI for Detection of Skeletal Metastases
Official title: Combined 18F-NaF/18F-FDG PET/MRI for Detection of Skeletal Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2006-09-13
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

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.

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 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.

Eligibility 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

Primary outcomes:
measure: Cohort 1 - NaF PET/CT vs 99mTc-MDP Bone Scintigraphy
timeFrame: 30 days
Secondary outcomes:
measure: Cohort 1 - 18F-NaF PET/CT vs 18F-FDG PET/CT
timeFrame: 30 days
measure: Cohort 1 - Whole-body MRI vs 18F-NaF PET/CT
timeFrame: 30 days
measure: Cohort 1 - Whole-body MRI vs 18F-FDG PET/CT
timeFrame: 30 days
measure: Cohort 1 - Detection of Osseous (Skeletal) Metastases by 18F-NaF and 18F-FDG PET/CT
timeFrame: 30 days
measure: Cohort 2 - 18F-NaF/18F-FDG PET/CT vs Whole-body MRI for Detection of Extraskeletal Lesions
timeFrame: 30 days
measure: Cohort 2 - 18F-NaF/18F-FDG vs Whole-body MRI for Detection of Skeletal Lesions
timeFrame: 30 days
measure: Cohort 2 - 18F-NaF/18F-FDG vs 99mTc-MDP Bone Scintigraphy for Detection of Skeletal Lesions
timeFrame: 30 days
measure: Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI
timeFrame: 30 days
measure: Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI/99mTc-MDP Bone Scintigraphy
timeFrame: 30 days
measure: Cohort 3 - Skeletal Lesions Identified by 99mTc MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI
timeFrame: 30 days
measure: Cohort 3 - Total Skeletal Lesions Identified, Tc-99m MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI
timeFrame: 30 days
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Andrei Iagaru, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.