18F-NaF-PET/MR vs 99mTc-MDP-SPECT/CT to Detect Bone Metastases in Prostate Cancer Patients.

Completed

• Conditions: Bone Metastases; Prostate Cancer
• Interventions: Other: scintigraphy 99mTc-MDP-SPECT/CT.; Other: 18F-NaF-PET/MR

• Registration Number: NCT02969564
• Lead Sponsor: Valentina Garibotto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-21
• Study Start: 2016-05
• Study First Submitted QC: 2016-11-16
• Study First Posted: 2016-11-21
• Primary Completion: 2018-05
• Study Completion: 2020-09-14
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
prostate cancer patient, with up to five metastases	scintigraphy 99mTc-MDP-SPECT/CT.	prostate cancer patient, with up to five metastases (oligo-bone metastatic) based on scintigraphy 99mTc-MDP-SPECT/CT.
prostate cancer patient, with up to five metastases	18F-NaF-PET/MR	prostate cancer patient, with up to five metastases (oligo-bone metastatic) based on scintigraphy 99mTc-MDP-SPECT/CT.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Geneva University Hospital; 🇨🇭 Geneva, Switzerland