Bone Metastases, Prostate Cancer
Conditions
Keywords
prostate cancer, bone metastases, PET/MRI
Brief summary
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.
Interventions
OTHERscintigraphy 99mTc-MDP-SPECT/CT.
SPECT/CT will be performed for every patient in the frame of their clinical follow up
OTHER18F-NaF-PET/MR
a 18F-NaF-PET/MR will be performed, in the frame of this clinical study, to the patients to assess the difference of sensitivity of the 2 exams
Sponsors
University Hospital, Geneva
Valentina Garibotto
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | through study completion, an average of 2 years | 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
| Measure | Time frame | Description |
|---|---|---|
| To assess differences in sensitivity and specificity in detecting bone metastases between the two imaging modalities. | through study completion, an average of 2 years | Sensitivity and specificity of PET and SPECT for the detection of secondary bone lesions (gold standard: clinical and imaging follow up) |
| To determine the number of equivocal and diagnostic tests resulting from the two imaging modalities. | through study completion, an average of 2 years | rate of equivocal/non equivocal findings for the two modalities |
Countries
Switzerland
Outcome results
None listed