Whole Body Fluorine F 18 Sodium Fluoride PET/CT Scan and Whole Body MRI in Finding Bone Metastases in Patients With Prostate Cancer

National Cancer Institute (NCI)

Status and phase

Completed

Early Phase 1

Conditions

Stage IV Prostate Cancer

Stage I Prostate Cancer

Stage IIA Prostate Cancer

Stage III Prostate Cancer

Recurrent Prostate Cancer

Stage IIB Prostate Cancer

Bone Metastases

Treatments

Procedure: computed tomography

Other: laboratory biomarker analysis

Radiation: technetium Tc 99m methylene diphosphonate

Procedure: magnetic resonance imaging

Radiation: fluorine F 18 sodium fluoride

Procedure: positron emission tomography

Study type

Interventional

Funder types

NIH

Identifiers

NCT00956163

CDR0000666327

NCI-2011-02972 (Registry Identifier)

P30CA006516 (U.S. NIH Grant/Contract)

N01CM37120 (U.S. NIH Grant/Contract)

09-364 (Other Identifier)

8336 (Other Identifier)

MGH-09364

Details and patient eligibility

About

This phase 0 trial studies whole body fluorine F 18 sodium fluoride positron emission tomography (PET)/computed tomography (CT) scan and whole body magnetic resonance imaging (MRI) in finding bone metastases in patients with prostate cancer. Diagnostic procedures, such as whole body fluorine F 18 sodium fluoride PET/CT scan and whole body MRI, may help find and diagnose bone metastases.

Full description

PRIMARY OBJECTIVES:

I. To evaluate the sensitivity and specificity of whole-body fluorine F 18 sodium fluoride PET/CT scan in detecting bone metastases in patients with high-risk prostate cancer using bone scan as the reference standard.

II. To evaluate the sensitivity and specificity of whole-body MRI in detecting bone metastases in patients with high-risk prostate cancer using bone scan as the reference standard.

OUTLINE:

Patients undergo technetium Tc 99m methylene diphosphonate bone scan, fluorine F 18 sodium fluoride PET/CT scan, and whole-body MRI for the detection of bone metastases. Patients with discordant imaging results (negative bone scan and positive PET/CT scan and/or MRI) undergo additional imaging at 6, 12, 18, and 24 months.

Enrollment

50 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Any ethnic group
Pathologically proven prostate cancer with high risk for bone metastases
Rising prostate-specific antigen (PSA) despite androgen deprivation therapy (ADT), PSA > 10 ng/mL
Ability to understand and the willingness to sign a written combined Health Insurance Portability and Accountability Act (HIPAA) and informed consent document
Patients Eastern Cooperative Oncology Group (ECOG) performance is =< 1

Exclusion criteria

Patients may not receive any other investigational therapeutic agents from within 7 days prior to study drug administration through 7 days following study drug administration
Patients with known contraindications to MR imaging such as presence of MRI incompatible devices such as pacemakers and certain aneurysm clips, severe claustrophobia, or any other condition which would preclude proximity to a strong magnetic field; this exclusion is a standard of practice
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; patients in this category are excluded to reduce medical risk to their safety and to avoid confounding variables in regard to the possibility of adverse events
Patient is unable to tolerate or has a lifer threatening allergy to the radiopharmaceutical used for bone scan or 18F-fluoride PET