Novel PET Imaging for Breast Cancer

Overseen By Ilda Bander

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Randy Yeh

Disqualifiers: Pregnancy, Lactation, High bilirubin, others

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

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging method to better detect breast cancer that has spread (metastasized) in patients with invasive lobular breast cancer. Researchers compare two PET scans: the standard one and a new type called 18F-FAPI-74 (a novel imaging agent), to determine which better identifies cancer. The goal is to enhance how doctors see and understand the cancer to improve treatment decisions. This study targets women diagnosed with metastatic invasive lobular breast cancer who do not plan to change their current treatment soon. As a Phase 2 trial, this research measures how well the new imaging method works in an initial, smaller group of people, offering participants a chance to contribute to advancements in cancer detection.

What prior data suggests that this imaging method is safe for patients?

Research shows that 18F-FAPI-74 PET/CT scans are generally easy for patients to handle. Although detailed safety data for 18F-FAPI-74 in this specific use is lacking, studies for other purposes suggest it can effectively detect cancer with few problems, indicating likely safety.

Conversely, 18F-FDG PET/CT is a common imaging method for diagnosing and assessing breast cancer. Research has shown it is safe and widely used in medical settings, with most patients experiencing no major side effects.

In summary, both 18F-FAPI-74 and 18F-FDG are considered safe imaging options that patients can generally tolerate well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 18F-FAPI-74 PET/CT imaging for breast cancer because it offers a new way to visualize tumors using a novel radioactive tracer. Unlike the more commonly used 18F-FDG PET/CT, which highlights glucose metabolism in cancer cells, 18F-FAPI-74 targets fibroblast activation protein, which is often highly expressed in cancerous tissues. This could potentially provide clearer, more specific images of tumors, leading to better diagnosis and treatment planning. By offering a different mechanism of action, 18F-FAPI-74 could improve the accuracy of cancer detection and help tailor treatments more effectively.

What evidence suggests that this imaging method is effective for detecting metastatic invasive lobular breast cancer?

Research has shown that a new imaging method, 18F-FAPI-74 PET/CT, might detect breast cancer more effectively than the standard 18F-FDG PET/CT. One study found that 18F-FAPI-74 was more effective at identifying cancer in both the original tumor and metastatic areas. Another study demonstrated that 18F-FAPI-74 performed well across different types of breast cancer. In this trial, participants will undergo both the standard-of-care 18F-FDG PET/CT and the investigational 18F-FAPI-74 PET/CT to compare their effectiveness. The current method, 18F-FDG PET/CT, is already proficient at detecting breast cancer, especially in recurrent or early-stage cases. However, 18F-FAPI-74 might offer superior detection, particularly for invasive lobular breast cancer, which is often challenging to identify. ^{1 3 6 7 8}

Who Is on the Research Team?

Randy Yeh, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for patients with metastatic invasive lobular breast cancer. Participants will undergo two types of PET/CT scans within a 2-week period to compare the effectiveness in detecting tumors.

Inclusion Criteria

Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study

I am a woman older than 18.

Provision of signed and dated informed consent form

Exclusion Criteria

Patients who are pregnant or lactating

I cannot have a PET/CT scan.

My bilirubin or creatinine levels are not more than 1.5 times the normal upper limit.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo both 18F-FDG PET/CT and 18F-FAPI-74 PET/CT scans to compare lesions, tumor detection rates, and PET lesion intensity

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in therapeutic management decisions and disease status assessment

1 month

What Are the Treatments Tested in This Trial?

Interventions

• 18F-FAPI-74
• 18F-FDG

Trial Overview

The study tests two imaging techniques: 18F-FAP (a novel agent) and standard 18F-FDG, both used in PET/CT scans. It aims to see which one better detects lesions and provides more useful information for treatment decisions.

How Is the Trial Designed?

Group I: 18F-FAPI-74 PET/CT and 18F-FDG PET/CT Experimental Treatment 3 Interventions

Study participants will undergo both standard-of-care whole body 18F-FDG PET/CT scan and investigational whole-body scan 18F-FAPI-74 PET/CT.

Who Is Running the Clinical Trial?

Randy Yeh

Lead Sponsor

The Society of Nuclear Medicine and Molecular Imaging

Collaborator

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07285993

Detection and Outcomes in Metastatic Invasive Lobular ...

Patients will undergo both 18F-FDG PET/CT and 18F-FAPI-74 PET/CT within a 2-week period (14 days + 7 days) to compare lesions, tumor detection ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12686520/

A prospective comparison of early versus late 18F-FAPI−04 ...

This study found that both early and late 18F-FAPI-04 PET/CT imaging performed excellently in the diagnosis of suspected breast cancer patients, ...

3.

jnm.snmjournals.org

jnm.snmjournals.org/content/early/2023/06/01/jnumed.123.265486

Initial Evaluation of [18F]FAPI-74 PET for Various ...

Conclusion: [18F]FAPI-74 PET showed higher uptake and detection rates in primary and metastatic lesions than did [18F]FDG PET. [18F]FAPI-74 PET ...

4.

bcan.org

bcan.org/clinicaltrials/18f-fibroblast-activation-protein-inhibitor-18ffapi-74-pet-imaging-for-cancer-detection/

18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) ...

Researchers believe that [18F]FAPI-74 PET imaging may be able to visualize cancer more effectively than the approved tracers. If so, the new tracer would make ...

5.

nature.com

nature.com/articles/s44303-024-00053-z

Clinical applications of fibroblast activation protein ...

In one study, FAPI was effective in the major histologic subtypes (invasive ductal carcinoma: IDC 89.6%) and ILC (10.4%), while 18F-FDG showed ...

6.

cancer.gov

cancer.gov/clinicaltrials/NCI-2024-06149

18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) ...

Researchers believe that [18F]FAPI-74 PET imaging may be able to visualize cancer more effectively than the approved tracers. If so, the new tracer would make ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07217717

Study Details | NCT07217717 | Using 18F-FAPI PET to ...

To assess the safety profile of [¹⁸F]FAPI-74 PET/CT. 24-72 hours post-injection. Cohen's kappa for pairwise evaluation of inter- and intra ...

8.

trials.teamjackfoundation.org

trials.teamjackfoundation.org/trials/NCT06503146

18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET ...

Researchers believe that [18F]FAPI-74 PET imaging may be able to visualize cancer more effectively than the approved tracers. If so, the new tracer would make ...