Clinical Trials Directory

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

TypeNameDescription
OTHERscintigraphy 99mTc-MDP-SPECT/CT.SPECT/CT will be performed for every patient in the frame of their clinical follow up
OTHER18F-NaF-PET/MRa 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.