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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02969564
• Other study ID #: 15-118
• Status: Completed
• Start date: May 2016
• Est. completion date: September 14, 2020

Study information

• Verified date: November 2020
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 14, 2020
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Metastases
• Bone Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• 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

Locations

Country	Name	City	State
Switzerland	Geneva University Hospital	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
Valentina Garibotto	University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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.	through study completion, an average of 2 years
Secondary	To assess differences in sensitivity and specificity in detecting bone metastases between the two imaging modalities.	Sensitivity and specificity of PET and SPECT for the detection of secondary bone lesions (gold standard: clinical and imaging follow up)	through study completion, an average of 2 years
Secondary	To determine the number of equivocal and diagnostic tests resulting from the two imaging modalities.	rate of equivocal/non equivocal findings for the two modalities	through study completion, an average of 2 years