Clinical trial · Interventional
Combined 18F-NaF/18F-FDG PET/MRI for Detection of Skeletal Metastases
NCT00375830CI-TRIAL-00072158completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-Fludeoxyglucose (18F-FDG) | Drug | — | UNRESOLVED |
| 18F-Sodium Fluoride (18F-NaF) | Drug | — | UNRESOLVED |
| 99mTc-methyl diphosphonate | Drug | — | UNRESOLVED |
| Bone scan | Procedure | — | UNRESOLVED |
| Computed Tomography (CT) scan | Procedure | — | UNRESOLVED |
| Gadobutrol | Drug | — | UNRESOLVED |
| Gadofosveset | Drug | — | UNRESOLVED |
| Gadopentetate dimeglumine | Drug | — | UNRESOLVED |
| Positron Emission Tomography (PET) scan |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans
- 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.
- interventionNames
- Procedure: Bone scan
- Drug: 99mTc-methyl diphosphonate
- Procedure: Positron Emission Tomography (PET) scan
- Drug: 18F-Fludeoxyglucose (18F-FDG)
- Procedure: Computed Tomography (CT) scan
- Drug: 18F-Sodium Fluoride (18F-NaF)
- Drug: Gadopentetate dimeglumine
- type
- EXPERIMENTAL
- label
- Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans
- description
- Assessment to define the accuracy of the combined 18F-NaF CT \& 18F-FDG PET/CT scan procedures compared to 99mTc MDP bone scan.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- RESULTIagaru 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. PMID 23455520
- RESULTMinamimoto 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. PMID 26405167
- RESULTIagaru 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. PMID 26956325
- RESULTSonni 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. PMID 31236756