[F-18]NaF-PET for bone imaging

JRCT ID: jRCT2052230066

Registered date:08/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: metastatic bone tumor
• Date of first enrollment: 31/07/2023
• Target sample size: 23
• Study type: Interventional
• Intervention(s): [F-18]NaF PET/CT, whole body MRI

Outcome(s)

• Primary Outcome: 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 Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Okazawa Hidehiko