Trials / Completed
CompletedNCT02969564
18F-NaF-PET/MR vs 99mTc-MDP-SPECT/CT to Detect Bone Metastases in Prostate Cancer Patients.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 12 (actual)
- Sponsor
- Valentina Garibotto · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | scintigraphy 99mTc-MDP-SPECT/CT. | SPECT/CT will be performed for every patient in the frame of their clinical follow up |
| OTHER | 18F-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 |
Timeline
- Start date
- 2016-05-01
- Primary completion
- 2018-05-01
- Completion
- 2020-09-14
- First posted
- 2016-11-21
- Last updated
- 2020-11-04
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT02969564. Inclusion in this directory is not an endorsement.