[F-18]NaF-PET for bone imaging

[F-18]NaF-PET study for diagnosis of metastatic bone tumor

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2052230066

Enrollment

Registered

2023-07-08

Start date

2023-07-31

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastatic bone tumor PET, bone meta.

Interventions

[F-18]NaF PET/CT, whole body MRI

D049268

[F-18]NaF PET

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Suspected metastatic bone tumor in clinical practice (by bone pain, tumor markers, imaging except for bone scintigrapgy, etc.) - Adults 20 years of age or older who have been informed of the disease name and condition, and who have the capacity to consent. - ECOG Performance Status: 0-1

Exclusion criteria

Exclusion criteria: - Patients who have difficulty with supine rest for 30 minutes or longer. - Patients who have already started treatment for metastatic bone tumors. - Patients who have been diagnosed with osteoporosis and are being or will be treated. - Pregnant, possibly pregnant, or nursing mothers. - Patients with serious drug allergies. - Patients with pacemakers or other non-MRI-compatible metal objects in the body. - Patients with tattoos including art makeup. - Patients with claustrophobia. - Patients deemed inappropriate by the investigator/ subinvestigator due to medical, psychological, or other factors.

Design outcomes

Primary

Measure	Time frame
To verify that the diagnostic accuracy of the [F-18]NaF PET test for bone metastases exceeds the clinically required value (accuracy of bone scintigraphy).	—

Secondary

Measure	Time frame
1) Sensitivity, specificity, positive predictive value, and negative predictive value of [F-18]NaF PET in the diagnosis of bone metastases. 2) Diagnostic performance (positive predictive value, sensitivity, specificity, positive predictive value, negative predictive value) of [F-18]NaF PET/CT examinations (including CT and fusion imaging). 3) Diagnostic performance (positive predictive value, sensitivity, specificity, positive predictive value, negative predictive value) of [F-18]NaF-PET for metastatic bone lesions in each site by classifying whole body bones into extremities (upper arm, forearm, femur, lower leg to foot), skull, ribs, sternum, clavicle, spine (CV, ThV, LV, sacrum to coccyx), and pelvis bones.	—

Measure

Time frame

1) Sensitivity, specificity, positive predictive value, and negative predictive value of [F-18]NaF PET in the diagnosis of bone metastases. 2) Diagnostic performance (positive predictive value, sensitivity, specificity, positive predictive value, negative predictive value) of [F-18]NaF PET/CT examinations (including CT and fusion imaging). 3) Diagnostic performance (positive predictive value, sensitivity, specificity, positive predictive value, negative predictive value) of [F-18]NaF-PET for metastatic bone lesions in each site by classifying whole body bones into extremities (upper arm, forearm, femur, lower leg to foot), skull, ribs, sternum, clavicle, spine (CV, ThV, LV, sacrum to coccyx), and pelvis bones.

—

Contacts

Public ContactHidehiko Okazawa

University of Fukui

okazawa@u-fukui.ac.jp+81-776-61-8491

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026