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

Valentina Garibotto

Status: Completed

Conditions: Prostate Cancer; Bone Metastases

Treatments: Other: 18F-NaF-PET/MR; Other: scintigraphy 99mTc-MDP-SPECT/CT.

Study type: Observational

Funder types: Other

Identifiers

NCT02969564

15-118

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

12 participants in 1 patient group

prostate cancer patient, with up to five metastases

Description:

prostate cancer patient, with up to five metastases (oligo-bone metastatic) based on scintigraphy 99mTc-MDP-SPECT/CT.

Treatment:

Other: 18F-NaF-PET/MR

Other: scintigraphy 99mTc-MDP-SPECT/CT.