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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an imaging method called 18F-sodium fluoride (18F-NaF) to determine its safety and effectiveness as an alternative for detecting bone problems, especially during isotope shortages. It focuses on individuals needing a bone scan to check for issues like cancer or infections in their bones. Candidates may qualify if their doctor has recommended a bone scan and they can lie still on their back for at least 15 minutes. As a Phase 3 trial, this study represents the final step before FDA approval, providing an opportunity to contribute to a potentially groundbreaking diagnostic method.

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 prior data suggests that 18F-NaF is safe for PET imaging in bone cancer?

Research has shown that 18F-sodium fluoride (18F-NaF) is generally safe for patients. Studies have found that it accumulates in areas with bone issues, helping doctors identify these problems more clearly. This makes it a useful tool for detecting bone diseases. Significant harmful side effects have not been reported when using 18F-NaF in scans.

The treatment has already received approval for certain uses, indicating prior safety testing. This trial is in an advanced stage, suggesting it has already passed earlier safety tests, providing reassurance about its safety for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 18F-sodium fluoride (18F-NaF) PET imaging for bone cancer because it offers a potentially more precise way to detect bone metastases compared to traditional bone scintigraphy. Unlike standard bone scans that use technetium-99m, 18F-NaF provides higher resolution images that can help doctors spot cancer spread earlier. This imaging technique could lead to faster and more accurate treatment decisions, ultimately improving patient outcomes.

What evidence suggests that 18F-NaF PET imaging is effective for bone cancer?

Research has shown that 18F-sodium fluoride (18F-NaF) PET scans, which participants in this trial may undergo, excel at detecting cancer that has spread to the bones. Studies indicate that 18F-NaF PET/CT scans can identify more bone metastases than traditional methods like 99m-technetium bone scans. One study found that 18F-NaF PET/CT detected more metastases in 83% of patients compared to another type of PET scan. This method also effectively confirms when cancer has not spread to the bones, even when other scans are unclear. These findings suggest that 18F-NaF is a powerful tool for early identification of bone issues. ^{1 4 6 7 8}

Who Is on the Research Team?

Éric E Turcotte, MD

Principal Investigator

Université de Sherbrooke, Centre de Recherche du CHUS

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

(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]

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]

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]

(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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4258001/

Sodium 18F-Fluoride PET/CT of Bone, Joint and Other ...

18F-fluoride PET/CT is highly effective for excluding bone metastases even in patients with equivocal bone scintigraphy. Eur J Nucl Med Mol Imaging. 2012;39 ...

2.

ajronline.org

ajronline.org/doi/10.2214/AJR.13.12158

18F-Sodium Fluoride PET Imaging of Osseous Metastatic ...

OBJECTIVE. This literature review details the history, pharmacokinetics, and utility of 18F-sodium fluoride (Na18F) PET/CT in detecting osseous metastases ...

3.

cms.gov

cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id233_mccarthy_comment.pdf

Review of Published Literature on the Use of Sodium ...

This is a prospective trial to evaluate the sensitivity and specificity of 18F-fluoride PET to detect bone metastases in patients with breast cancer. The ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2212137415300099

The role of 18F–NaF PET/CT in metastatic bone disease

18F–NaF PET/CT demonstrated a greater number of metastases in 10/12 (83%) of the patients when compared to 18F-FDG PET/CT. In the other two patients, bone ...

5.

tech.snmjournals.org

tech.snmjournals.org/content/48/1/9

18F-Sodium Fluoride PET: History, Technical Feasibility ...

In one prospective study with prostate cancer patients, 18F-NaF PET/CT was able to detect a higher number of bone metastases than 99mTc-MDP bone ...

6.

dctd.cancer.gov

dctd.cancer.gov/drug-discovery-development/reagents-materials/imaging-ind-resources/documentation/naf-ib.pdf

sodium fluoride f 18 injection investigator's brochure

The tendency for fluoride 18F to accumulate in the vicinity of primary and metastatic malignancy in bone has proven clinically useful in detection of such ...

7.

jnm.snmjournals.org

jnm.snmjournals.org/content/51/11/1813

SNM Practice Guideline for Sodium 18F-Fluoride PET/CT ...

The purpose of this information is to assist health care professionals in performing, interpreting, and reporting the results of PET/CT bone scans performed ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34706830/

18F-sodium fluoride positron emission tomography (NaF-18 ...

Patients with osteoblastic metastases from high risk osteosarcoma continue to have a poor prognosis after progression from standard-of-care ...