NaF PET Imaging for Bone Cancer
Palo Alto (17 mi)Overseen byÉric E Turcotte, MD
Age: Any Age
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?18F-sodium fluoride (18F-NaF) was already investigated numerous times in the last 40 years as a PET alternative to standard 99m-technetium-derived bone scintigraphy. However, lack of universal tracer availability and higher costs contributed to the failure of 18F-NaF to systematically supplant bone scintigraphy as a standard of care.
Recently, an isotope shortage crisis occurred and evidenced the need to have non-reactor-derived alternatives for many nuclear medicine procedures, including bone scintigraphy. Since 18F-NaF is cyclotron-produced, it could become a necessary alternative to bone scintigraphy in case of another worldwide isotope shortage.
The study aims to evaluate the safety profile of 18F-NaF injection. Moreover, a patient registry will be compiled in order to perform sub-studies on 18F-NaF diagnostic performance on diverse bone and articular diseases.
Is the drug 18F-sodium fluoride a promising treatment for bone cancer?Yes, 18F-sodium fluoride is a promising drug for bone cancer. It provides high-quality images that help doctors accurately detect and assess bone cancer. This drug is more sensitive and specific than older methods, making it a valuable tool in diagnosing and managing bone cancer.12457
What safety data exists for 18F-NaF PET imaging in bone cancer?18F-NaF, a radiopharmaceutical approved by the FDA in 1972, is used in PET/CT imaging for bone cancer. It has favorable pharmacokinetics, high sensitivity, and specificity for detecting bone metastases. While no robust evidence-based safety data is explicitly mentioned, its clinical use and expanded coverage by the National Oncologic PET Registry suggest a recognized safety profile.12478
What data supports the idea that NaF PET Imaging for Bone Cancer is an effective treatment?The available research shows that NaF PET Imaging is effective for bone cancer because it provides better detection of bone metastases compared to older methods. It has higher sensitivity and specificity, meaning it is more accurate in identifying cancer spread to the bones. This imaging technique also offers quicker results, which is more convenient for patients. Compared to traditional methods, NaF PET Imaging is more reliable and efficient in evaluating bone disease, making it a valuable tool in cancer treatment.12346
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators or your doctor for guidance.
Eligibility Criteria
This trial is for patients who need a bone scan (99mTc-biphosphonate bone scintigraphy) due to conditions like infections, arthritis, or bone tumors. It includes adults and children with cancer or infectious diseases needing this test. Pregnant individuals, those allergic to 18F-NaF, or unable to lie flat for at least 15 minutes cannot participate.Inclusion Criteria
I can lie on my back comfortably.
I am a child needing a bone scan for cancer or infection.
Exclusion Criteria
I cannot lie on my back for more than 15 minutes.
Treatment Details
The study tests the safety and effectiveness of using an imaging agent called 18F-sodium fluoride (18F-NaF) in PET scans as an alternative to standard bone scintigraphy. This could be important if there's another shortage of the usual radioactive material used in these scans.
1Treatment groups
Experimental Treatment
Group I: 18F-NaF eligible patientsExperimental Treatment1 Intervention
Eligibility for 18F-NaF PET scans is the same than for bone scintigraphy routinely prescribed in the clinic.
18F-sodium fluoride is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as 18F-NaF for:
- Bone metastasis detection
- Skeletal imaging for benign and malignant disorders
🇪🇺 Approved in European Union as 18F-NaF for:
- Bone metastasis detection
- Skeletal imaging for benign and malignant disorders
Find a clinic near you
Research locations nearbySelect from list below to view details:
CHUSSherbrooke, Canada
Université deSherbrookeSherbrooke, Canada
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Who is running the clinical trial?
Centre de recherche du Centre hospitalier universitaire de SherbrookeLead Sponsor
Université de SherbrookeCollaborator
References
Clinical utility of (18)F-fluoride PET/CT in benign and malignant bone diseases. [2016](18)F labeled sodium fluoride is a positron-emitting, bone seeking agent with more favorable skeletal kinetics than conventional phosphate and diphosphonate compounds. With the expanding clinical usage of PET/CT, there is renewed interest in using (18)F-fluoride PET/CT for imaging bone diseases. Growing evidence indicates that (18)F fluoride PET/CT offers increased sensitivity, specificity, and diagnostic accuracy in evaluating metastatic bone disease compared to (99m)Tc based bone scintigraphy. National Oncologic PET Registry (NOPR) has expanded coverage for (18)F sodium fluoride PET scans since February 2011 for the evaluation of osseous metastatic disease. In this article, we reviewed the pharmacological characteristics of sodium fluoride, as well as the clinical utility of PET/CT using (18)F-fluoride in both benign and malignant bone disorders.
Newer PET application with an old tracer: role of 18F-NaF skeletal PET/CT in oncologic practice. [2022]The skeleton is one of the most common sites for metastatic disease, particularly from breast and prostate cancer. Bone metastases are associated with considerable morbidity, and accurate imaging of the skeleton is important in determining the appropriate therapeutic plan. Sodium fluoride labeled with fluorine 18 (sodium fluoride F 18 [(18)F-NaF]) is a positron-emitting radiopharmaceutical first introduced several decades ago for skeletal imaging. (18)F-NaF was approved for clinical use as a positron emission tomographic (PET) agent by the U.S. Food and Drug Administration in 1972. The early use of this agent was limited, given the difficulties of imaging its high-energy photons on the available gamma cameras. For skeletal imaging, it was eventually replaced by technetium 99m ((99m)Tc)-labeled agents because of the technical limitations of (18)F-NaF. During the past several years, the widespread availability and implementation of hybrid PET and computed tomographic (CT) dual-modality systems (PET/CT) have encouraged a renewed interest in (18)F-NaF PET/CT for routine clinical use in bone imaging. Because current PET/CT systems offer high sensitivity and spatial resolution, the use of (18)F-NaF has been reevaluated for the detection of malignant and nonmalignant osseous disease. Growing evidence suggests that (18)F-NaF PET/CT provides increased sensitivity and specificity in the detection of bone metastases. Furthermore, the favorable pharmacokinetics of (18)F-NaF, combined with the superior imaging characteristics of PET/CT, supports the routine clinical use of (18)F-NaF PET/CT for oncologic imaging for skeletal metastases. In this article, a review of the indications, imaging appearances, and utility of (18)F-NaF PET/CT in the evaluation of skeletal disease is provided, with an emphasis on oncologic imaging.
18F-fluoride PET used for treatment monitoring of systemic cancer therapy: results from the National Oncologic PET Registry. [2022]In a national prospective registry, we previously studied the impact of (18)F-sodium fluoride PET (NaF PET) on the intended management of cancer patients with osseous metastases. The clinical impact of NaF PET for monitoring the response to systemic therapies in such patients is unknown. The objective of this study was to assess the impact of NaF PET results obtained for treatment monitoring of systemic cancer therapy.
(18)F NaF PET/CT in the Assessment of Malignant Bone Disease. [2016]Diagnostic imaging plays a major role in the evaluation of patients with malignant bone disease. (18)F-Labeled sodium fluoride ((18)F NaF) is a positron-emitting radiopharmaceutical with desirable characteristics (rapid blood clearance and bone uptake) for high-quality functional imaging of the skeleton. In addition to higher sensitivity and specificity, (18)F NaF PET combined with computed tomography (PET/CT) allows for shorter imaging time, thus improving patients' convenience and benefiting the overall workflow of the imaging facility. Although as yet no robust evidence-based data exist, this article summarizes the published data currently available on the role of (18)F NaF PET/CT in the assessment of malignant bone disease.
The Role of 18F-Sodium Fluoride PET/CT Bone Scans in the Diagnosis of Metastatic Bone Disease from Breast and Prostate Cancer. [2022]We describe the role of 18F-sodium fluoride (18F-NaF) PET/CT bone scanning in the staging of breast and prostate cancer. 18F-NaF PET was initially utilized as a bone scanning agent in the 1960s and early 1970s, however, its use was restricted by the then-available γ-cameras. The advent of hybrid PET/CT cameras in the late 1990s has shown a resurgence of interest in its use and role. After a brief introduction, this paper describes the radiopharmaceutical properties, dosimetry, pharmacokinetics, and mechanism of uptake of 18F-NaF. The performance of 18F-NaF PET/CT is then compared with that of conventional bone scintigraphy using current evidence from the literature. Strengths and weaknesses of 18F-NaF PET/CT imaging are highlighted. Clinical examples of improved accuracy of diagnosis and impact on patient management are illustrated. Limitations of 18F-NaF PET/CT imaging are outlined.
Skeletal Metastases and Benign Mimics on NaF PET/CT: A Pictorial Review. [2019]Label="OBJECTIVE" NlmCategory="OBJECTIVE">The aim of this article is to present examples in which sodium fluoride labelled with 18F (NaF) bone PET/CT would be a useful adjunct to guide complex clinical decisions about the staging, restaging, and treatment approach for patients with skeletal metastases and benign causes of NaF activity that can be mistaken for bone metastases. We present a pictorial review of selected cases of this cohort of patients.
18F-Sodium Fluoride PET/CT and PET/MR Imaging of Bone and Joint Disorders. [2019]18F-sodium fluoride (18F-NaF) PET/CT provides high sensitivity and specificity for the assessment of bone and joint diseases. It is able to accurately differentiate malignant from benign bone lesions, especially when using dynamic quantitative approaches. Its high-quality, clinical accuracy, and high feasibility for patient management and greater availability of PET/CT scanners as well as decreasing trend of the cost of radiotracer all indicate the need to consider the use of 18F-NaF PET/CT as standard bone imaging, particularly in malignant diseases of the skeleton.
Spectrum of false positive 18F-sodium fluoride (NaF) bone PET/CT findings in Oncology imaging; A narrative pictorial review of cases from a single institution. [2021]Fluorine-18-sodium fluoride (18F-NaF) is a positron emission tomography (PET) bone imaging agent mainly used for oncology staging but may also be used in the evaluation of benign bone and joint pathology conditions. Fluorine-18-NaF is an excellent bone-seeking agent with high bone uptake owing to favorable biodistribution with rapid single-pass extraction, limited plasma protein binding and prompt renal clearance. Fluorine-18-NaF PET/computed tomography (CT) is highly sensitive in identifying both sclerotic and lytic bone metastatic lesions. Occasionally 18F-NaF uptake in benign bone lesions can mimic malignantpathology. In these cases, the pattern of 18F-NaF uptake may elicit a specific diagnosis and correlation with clinical information and morphological information from correlative CT is essential for a correct diagnosis. In the present article, we present a series of clinical cases demonstrating examples of 18F-NaF uptake in benign lesions which can simulate malignant pathology in patients undergoing cancer staging.