18F-NaF PET Imaging for Bone Scintigraphy

• Status: Completed
• Trial end date: 2019-03-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: British Columbia Cancer Agency
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Treatments: Fluorides; Listerine; Sodium Fluoride; Technetium Tc 99m Medronate

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.