NaF PET Imaging for Bone Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Éric 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

Disqualifiers: Healthy, Pregnancy, Allergy, others

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug 18F-sodium fluoride for bone cancer?

Research shows that 18F-sodium fluoride, when used in PET/CT scans, is highly effective in detecting bone metastases, which are cancerous growths that spread to the bones. This drug provides clearer and more accurate images compared to older methods, helping doctors make better treatment decisions for patients with bone cancer. ^{1 2 3 4 5}

Is 18F-NaF PET imaging safe for humans?

18F-NaF PET imaging has been used for many years and is considered safe for humans. It was approved by the U.S. Food and Drug Administration in 1972 and is known for its rapid clearance from the blood and high uptake in bones, which makes it effective for imaging without significant safety concerns. ^{1 2 3 6 7}

How is the drug 18F-NaF different from other treatments for bone cancer?

18F-NaF PET/CT is unique because it offers higher sensitivity and specificity in detecting bone metastases compared to traditional bone scans, and it provides rapid imaging with better patient convenience. This drug is a positron-emitting agent that allows for high-quality imaging of the skeleton, making it particularly effective for assessing both malignant and benign bone diseases. ^{1 2 3 6 8}

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.

Patients for whom a 99mTc-biphosphonate bone scintigraphy is indicated

Exclusion Criteria

Known allergy or hypersensitivity to 18F-NaF or any of its constituants.

I cannot lie on my back for more than 15 minutes.

Refusal to sign the consent form

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 18F-NaF PET scans as an alternative to standard 99mTc bone scintigraphy

Ongoing

Follow-up

Participants are monitored for safety and effectiveness after treatment

17 years

Treatment Details

Interventions

• 18F-sodium fluoride (Radiopharmaceutical)

Trial Overview 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.

Participant Groups

Group I: 18F-NaF eligible patients Experimental Treatment 1 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 Nearby Select from list below to view details:

CHUS Sherbrooke, Canada

Université deSherbrooke Sherbrooke, Canada

Who Is Running the Clinical Trial?

Centre de recherche du Centre hospitalier universitaire de Sherbrooke Lead Sponsor

Université de Sherbrooke Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

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.

2. United States pubmed.ncbi.nlm.nih.gov

(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.

3. United States pubmed.ncbi.nlm.nih.gov

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.

4. United States pubmed.ncbi.nlm.nih.gov

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.

5. United States pubmed.ncbi.nlm.nih.gov

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.

6. United States pubmed.ncbi.nlm.nih.gov

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.

7. Greece pubmed.ncbi.nlm.nih.gov

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.

8. United States pubmed.ncbi.nlm.nih.gov

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.