NaF PET Imaging for Bone Cancer

Recruiting at 1 trial location

Overseen By Stéphanie Dubreuil

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Disqualifiers: Healthy, Pregnancy, Allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Ongoing

2500 Participants Needed

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}

Research Team

Éric E Turcotte, MD

Principal Investigator

Université de Sherbrooke, Centre de Recherche du CHUS

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

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

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

Who Is Running the Clinical Trial?

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Lead Sponsor

Trials

64

Recruited

33,600+

Université de Sherbrooke

Collaborator

Trials

317

Recruited

79,300+

Findings from Research

Sodium fluoride labeled with fluorine 18 (18F-NaF) is a highly effective radiopharmaceutical for skeletal imaging, particularly in detecting bone metastases from cancers like breast and prostate, showing increased sensitivity and specificity compared to traditional imaging methods.

The recent advancements in PET/CT technology have revitalized the clinical use of 18F-NaF, making it a valuable tool for oncologists in accurately assessing skeletal disease due to its favorable pharmacokinetics and superior imaging capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Newer PET application with an old tracer: role of 18F-NaF skeletal PET/CT in oncologic practice. Bastawrous, S., Bhargava, P., Behnia, F., et al.[2022]

(18)F-Labeled sodium fluoride ((18)F NaF) PET/CT imaging offers higher sensitivity and specificity for detecting malignant bone disease compared to traditional imaging methods, enhancing diagnostic accuracy.

The use of (18)F NaF PET/CT allows for quicker imaging times, improving patient convenience and the efficiency of imaging facilities, although more robust evidence is needed to fully establish its role in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(18)F NaF PET/CT in the Assessment of Malignant Bone Disease. Mosci, C., Iagaru, A.[2016]

(18)F labeled sodium fluoride is a highly effective imaging agent for bone diseases, showing better skeletal kinetics and diagnostic performance compared to traditional imaging methods like (99m)Tc based bone scintigraphy.

The use of (18)F-fluoride PET/CT has been recognized for its increased sensitivity and specificity in detecting metastatic bone disease, leading to expanded coverage for these scans by the National Oncologic PET Registry since February 2011.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical utility of (18)F-fluoride PET/CT in benign and malignant bone diseases. Li, Y., Schiepers, C., Lake, R., et al.[2016]

In a study involving 2,217 cancer patients aged 65 and older, (18)F-sodium fluoride PET (NaF PET) significantly influenced treatment decisions, with a 40% overall change in management based on scan results.

For patients showing new or progressive osseous metastasis, 59% of treating physicians planned to switch therapies, which increased to 76% when the estimated prognosis worsened, highlighting NaF PET's critical role in monitoring treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-fluoride PET used for treatment monitoring of systemic cancer therapy: results from the National Oncologic PET Registry. Hillner, BE., Siegel, BA., Hanna, L., et al.[2022]

Sodium fluoride labeled with 18F (NaF) PET/CT is a valuable imaging tool for accurately identifying bone metastases and distinguishing them from benign conditions that may mimic metastases in patients with cancer.

This hybrid imaging technique aids in clinical decision-making regarding staging, restaging, and treatment strategies for patients with skeletal metastases, enhancing the management of their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skeletal Metastases and Benign Mimics on NaF PET/CT: A Pictorial Review. Panagiotidis, E., Lam, K., Mistry, A., et al.[2019]

18F-sodium fluoride (18F-NaF) PET/CT is highly effective in distinguishing between malignant and benign bone lesions, making it a valuable tool for assessing bone and joint diseases.

The method's high sensitivity, specificity, and feasibility for patient management, along with the increasing availability of PET/CT scanners and decreasing costs of radiotracers, support its consideration as a standard imaging technique for bone-related malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-Sodium Fluoride PET/CT and PET/MR Imaging of Bone and Joint Disorders. Beheshti, M.[2019]

Fluorine-18-sodium fluoride (18F-NaF) is a highly effective PET imaging agent for detecting both malignant and benign bone conditions, showing high sensitivity in identifying bone metastatic lesions.

While 18F-NaF is excellent for oncology staging, its uptake in benign lesions can sometimes mimic malignant pathology, highlighting the importance of correlating imaging results with clinical and CT data for accurate diagnosis.

NCBI (Pubmed)

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. Usmani, S., Ahmed, N., Muzaffar, S., et al.[2021]

18F-sodium fluoride (18F-NaF) PET/CT bone scanning has shown improved accuracy in staging breast and prostate cancer compared to conventional bone scintigraphy, enhancing patient management decisions.

The paper discusses the radiopharmaceutical properties and mechanism of uptake of 18F-NaF, highlighting its resurgence in clinical use due to advancements in hybrid PET/CT technology since the late 1990s.

NCBI (Pubmed)

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. Kulshrestha, RK., Vinjamuri, S., England, A., et al.[2022]

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]

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

(18)F NaF PET/CT in the Assessment of Malignant Bone Disease. [2016]

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

Clinical utility of (18)F-fluoride PET/CT in benign and malignant bone diseases. [2016]

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]

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

Skeletal Metastases and Benign Mimics on NaF PET/CT: A Pictorial Review. [2019]

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

18F-Sodium Fluoride PET/CT and PET/MR Imaging of Bone and Joint Disorders. [2019]

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]

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]