Clinical trial · Observational
18F-NaF-PET/MR vs 99mTc-MDP-SPECT/CT to Detect Bone Metastases in Prostate Cancer Patients.
- 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)
The number of metastases in a patient with primary or recurrent prostate cancer has major prognostic implication. The purpose is to compare, in a pilot study, the diagnostic performance of 18F-NaF-PET/MR with respect to the results of the scintigraphy 99mTc-MDP-SPECT/CT (routine exam) for determining the presence or absence of bone lesions in prostate cancer patient, with up to five metastases (oligo-bone metastatic) based on scintigraphy 99mTc-MDP-SPECT/CT. The gold standard will be a combination of clinical follow-up, additional imaging and biopsy, as indicated by the multidisciplinary discussion at the tumor board. The findings from whole-body 99mTc-MDP-SPECT/CT, 18F-NaF-PET/MR, and the combination of the 2 modalities will be categorized by 2 teams of 2 readers as benign or probably benign, equivocal, or malignant or probably malignant and compared with the results of follow-up for JAFROC and ROC analysis.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Metastases | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-NaF-PET/MR | Other | — | UNRESOLVED |
| scintigraphy 99mTc-MDP-SPECT/CT. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- prostate cancer patient, with up to five metastases
- description
- prostate cancer patient, with up to five metastases (oligo-bone metastatic) based on scintigraphy 99mTc-MDP-SPECT/CT.
- interventionNames
- Other: scintigraphy 99mTc-MDP-SPECT/CT.
- Other: 18F-NaF-PET/MR
Primary outcomes (1)
- measure
- Compare the diagnostic performance of 18F-NaF-PET/MR scanning to that of whole body 99mTc-MDP-SPECT/CT for detecting cancer that has spread to the bone (bone metastasis)
- timeFrame
- through study completion, an average of 2 years
- description
- the primary measure will be differences in the area under the curves (AUC) of the receiver operating characteristic (ROC) curves that will be generated from the interpretations of each technology.
Secondary outcomes (2)
- measure
- To assess differences in sensitivity and specificity in detecting bone metastases between the two imaging modalities.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Oligo- metastatic patient with prostate cancer and bone lesions (up to five metastases) based on scintigraphy and whole-body SPECT/CT (staging or recurrence). * Patient must be able to provide informed consent. * Patient is ≥ 18 years old Exclusion Criteria: * Patient with another active malignancy. * Patient is \< 18 years old * Patients with contraindications of MRI procedure (metal implants, cardiac pacemakers, old type of prosthesis) * Patients with severe renal impairment (MDRD \< 30)
References
Publications (0)
Data not yet available