18F-NaF-PET/MR vs 99mTc-MDP-SPECT/CT to Detect Bone Metastases in Prostate Cancer Patients.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bone Metastases
- Sponsor
- Valentina Garibotto
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- 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)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Valentina Garibotto
Professor
University Hospital, Geneva
Eligibility Criteria
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)
Outcomes
Primary Outcomes
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)
Time Frame: 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 Outcomes
- To assess differences in sensitivity and specificity in detecting bone metastases between the two imaging modalities.(through study completion, an average of 2 years)
- To determine the number of equivocal and diagnostic tests resulting from the two imaging modalities.(through study completion, an average of 2 years)