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Trial record 80 of 291 for:    Sodium Fluoride OR Duraphat

18F-NaF PET Imaging for Bone Scintigraphy

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ClinicalTrials.gov Identifier: NCT01930812
Recruitment Status : Completed
First Posted : August 29, 2013
Last Update Posted : April 25, 2019
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
British Columbia Cancer Agency

Brief 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).

Condition or disease Intervention/treatment Phase
Bone Metastases From Breast or Prostate Cancer Procedure: NaF PET/CT Imaging Procedure: 99mTc-medronate whole body bone scan with SPECT Drug: 18F-Sodium Fluoride (NaF) Phase 3

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 286 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 18F- Sodium Fluoride PET Imaging as a Replacement for Bone Scintigraphy
Actual Study Start Date : July 2014
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Procedure: NaF PET/CT Imaging
Diagnostic imaging test that is considered investigational

Procedure: 99mTc-medronate whole body bone scan with SPECT
99mTc-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




Primary Outcome Measures :
  1. 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. [ Time Frame: At the 24 month post PET/CT follow-up physical examination. ]
    To compare the accuracy, sensitivity, and specificity of 18F-NaF imaging and 99mTc-MDP bone SPECT imaging for bone metastasis detection in patients with breast and prostate cancer.


Secondary Outcome Measures :
  1. The secondary outcome is to monitor the short-term side-effects following 18F-NaF PET/CT to assess for adverse drug reactions [ Time Frame: Short-term side effects will be monitored for 24 hours following the injection of 18F-NaF (investigational product), and 72 hours following administration of 99mTc-MDP (standard treatment) ]
    Given that 18F-NaF is the investigational agent in this study, the collection of adverse events will focus on identifying potential events related to the administration of this radiopharmaceutical. Adverse events will also be collected for bone scanning with 99mTc-medronate.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01930812


Locations
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Canada, Alberta
Edmonton Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Nova Scotia
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Hamilton Health Sciences Corp.
Hamilton, Ontario, Canada, L8N 3Z5
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
University Health Network
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Centre hospitalier universitaire de Sherbrooke
Fleurimont, Quebec, Canada, J1H 5N4
Centre hospitalier universitaire de Montréal
Montreal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
British Columbia Cancer Agency
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Francois Benard, MD British Columbia Cancer Agency

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Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT01930812     History of Changes
Other Study ID Numbers: MITNEC-A1
First Posted: August 29, 2013    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: December 2018
Keywords provided by British Columbia Cancer Agency:
18F-NaF PET/CT
Bone imaging
Additional relevant MeSH terms:
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Listerine
Fluorides
Sodium Fluoride
Prostatic Neoplasms
Neoplasm Metastasis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neoplastic Processes
Pathologic Processes
Technetium Tc 99m Medronate
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action