18F-NaF-PET/MR vs 99mTc-MDP-SPECT/CT to Detect Bone Metastases in Prostate Cancer Patients.
NCT ID: NCT02969564
Last Updated: 2020-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
12 participants
OBSERVATIONAL
2016-05-31
2020-09-14
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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prostate cancer patient, with up to five metastases
prostate cancer patient, with up to five metastases (oligo-bone metastatic) based on scintigraphy 99mTc-MDP-SPECT/CT.
scintigraphy 99mTc-MDP-SPECT/CT.
SPECT/CT will be performed for every patient in the frame of their clinical follow up
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
Interventions
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scintigraphy 99mTc-MDP-SPECT/CT.
SPECT/CT will be performed for every patient in the frame of their clinical follow up
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
Eligibility Criteria
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Inclusion Criteria
* Patient must be able to provide informed consent.
* Patient is ≥ 18 years old
Exclusion Criteria
* 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)
18 Years
MALE
No
Sponsors
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University Hospital, Geneva
OTHER
Valentina Garibotto
OTHER
Responsible Party
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Valentina Garibotto
Professor
Locations
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Geneva University Hospital
Geneva, , Switzerland
Countries
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Other Identifiers
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15-118
Identifier Type: -
Identifier Source: org_study_id