18F-NaF PET Imaging for Bone Scintigraphy
Bone Metastases From Breast or Prostate Cancer
About this trial
This is an interventional diagnostic trial for Bone Metastases From Breast or Prostate Cancer focused on measuring 18F-NaF PET/CT, Bone imaging
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.
Sites / Locations
- Edmonton Cross Cancer Institute
- BC Cancer Agency
- QEII Health Sciences Centre
- Hamilton Health Sciences Corp.
- St. Joseph's Healthcare Hamilton
- London Health Sciences Centre
- The Ottawa Hospital
- University Health Network
- Centre hospitalier universitaire de Sherbrooke
- Centre hospitalier universitaire de Montréal
Arms of the Study
Arm 1
Experimental
18F-NaF PET Imaging for Bone Scintigraphy
All participants will receive PET/CT Imaging using the investigational drug 18F-NaF and a 99mTc-medronate whole body bone scan with SPECT to compare the diagnostic ability of the two methods for the presence of bone metastases.