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Bone Metastases From Breast or Prostate Cancer | 18F-NaF PET Imaging for Bone Scintigraphy

Bone Metastases From Breast or Prostate Cancer research study

What is the primary objective of this study?

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).

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Bone Metastases From Breast or Prostate Cancer

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure:NaF PET/CT ImagingDiagnostic imaging test that is considered investigational

Procedure:99mTc-medronate whole body bone scan with SPECT99mTc-medronate whole body bone scan with SPECT imaging. Note, that this is a standard procedure in this patient population and thus is not considered investigational.

Drug:18F-Sodium Fluoride (NaF)A single radioactive dose of 18F-NaF (185-370 MBq) is intravenously administered to subject 60 minutes prior to PET/CT imaging to evaluate whether or not subject has bone metastasis from advanced prostate or breast cancer. Entire procedure from injection to scan completion will take about 2.25 hours

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

18F-NaF PET Imaging for Bone ScintigraphyAll 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.

Study Status

Completed

Start Date: July 2014

Completed Date: March 31, 2019

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Accuracy, sensitivity, and specificity of 18F-Sodium Fluoride (18F-NaF) Positron Emission Tomography compared to 99mTc-Methylene Diphosphonate (MDP) bone SPECT imaging for detection of bone metastasis.

Secondary Outcome: The secondary outcome is to monitor the short-term side-effects following 18F-NaF PET/CT to assess for adverse drug reactions

Study sponsors, principal investigator, and references

Principal Investigator: Francois Benard, MD

Lead Sponsor: British Columbia Cancer Agency

Collaborator: Canadian Institutes of Health Research (CIHR)

More information:https://clinicaltrials.gov/show/NCT01930812

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