18f-naf pet imaging for bone scintigraphy

Conditions: Bone Metastases From Breast or Prostate Cancer

Summary: the purpose of this study is to compare, in patients with prostate or breast cancer, the accuracy of 18f-naf pet imaging to 99mtc whole body bone scans with single-photon emission computed tomography (spect).

technetium-99m (99mtc) is the most widely used radionuclide in diagnostic nuclear medicine studies. it is used in 20 million diagnostic procedures worldwide annually. it became popular as a radioisotope because of its easy availability from a 99molybdenum (99mo)/99mtc generator, historic low costs, and previous high availability. the national research universal (nru) reactor at chalk river laboratories (ontario, canada) was shut down unexpectedly in may 2009 following a leak of heavy water. the nru reactor supplied approximately a third of the world's demand of 99mo for 99mo/99mtc generators used diagnostic nuclear medicine tests. given the fragility of 99mo supply, alternative radiopharmaceuticals, such as 18f-sodium fluoride (18f-naf), are attractive options to replace 99mtc bone scans. several studies suggest that 18f-naf may be more accurate and more sensitive in the detection of bone metastases than 99mtc bone scans.

Eligibility criteria:
all subject inclusion criteria * all subjects must have a who performance status 0-2. * subjects ≥ 18/19 years of age (depending on the age of majority in the province where the trial is conducted) for prostate cancer: male subjects requiring a bone scan for evaluation of bone metastasis with one (or more) of the following criteria: * symptomatic subjects with clinically suspected bone metastases based on a history of non-joint skeletal pain or non-joint skeletal tenderness on physical examination. the physician must have a high index of suspicion based on history or physical examination, such as night time pain or new onset of pain unexplained by trauma. such subjects must have a measurable psa level ≥ 4 ng/ml. * subjects with findings on other examinations (such as plain x-ray, ct, mri or bone scintigraphy and others) that are suspicious for bone metastases but not conclusively diagnostic of bone metastases. * asymptomatic subjects with newly diagnosed localized prostate cancer\[1\] and biopsy gleason sum 8 -10 (e.g. scores 3+5, 5+3, 4+4, 4+5, 5+4 or 5+5) prior to treatment. * asymptomatic subjects with newly diagnosed localized prostate cancer\[1\] and biopsy gleason score (4+3) and either psa level ≥ 20 or palpable disease (ct2b or greater) prior to treatment. * asymptomatic subjects with newly diagnosed localized prostate cancer\[1\] with psa level ≥ 20 and palpable disease (any ct2 or greater) prior to treatment. * asymptomatic subjects with a prior history of treated prostate cancer, and rising psa, with a psa doubling time \< 6 months, and a minimum psa level ≥ 4 ng/ml * asymptomatic subjects with a prior history of treated prostate cancer, and rising psa while under androgen deprivation therapy, with a clearly measurable psa doubling time \< 6 months (treatment does not need to be discontinued for eligibility). notes: \[1\] subjects with newly diagnosed prostate cancer who receive androgen deprivation therapy, for a duration of \< 6 months at the time of enrolment, prior to radiation therapy or surgery, remain eligible to participate in this study if they meet these inclusion criteria. for breast cancer: subjects (male or female) requiring a bone scan for evaluation of bone metastasis with one (or more) of the following criteria (19-23): * symptomatic subjects with clinically suspected bone metastases based on a history of non-joint skeletal pain or non-joint skeletal tenderness on physical examination. the physician must have a high index of suspicion based on history or physical examination, such as night time pain or new onset of pain unexplained by trauma. * subjects with findings on other examinations (such as plain x-ray, ct, mri or bone scintigraphy and others) that are suspicious for bone metastases but not conclusively diagnostic of bone metastases. * asymptomatic subjects with newly diagnosed extra-skeletal metastatic breast cancer (stage iv). * asymptomatic subjects with elevated serum cancer antigen (ca) 15.3 or alkaline phosphatase and newly diagnosed locally advanced breast cancer (stage iii). * asymptomatic subjects with nodal or extra-skeletal metastatic relapse during follow-up after curative-intent therapy. * asymptomatic subjects with new elevation of ca 15.3 or alkaline phosphatase during follow-up after curative-intent therapy. subject exclusion criteria * pregnancy. * inability to lie supine for the duration of the imaging studies. * subjects previously known for bone metastasis diagnosed by imaging or biopsy.

Keywords: 18f-naf pet/ct bone imaging