30 Participants Needed

18F-Fluoroestradiol PET/CT for Breast Cancer

Recruiting at 6 trial locations
KJ
RY
SG
SG
Overseen BySomali Gavane, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two types of scans to determine which is more effective at detecting and tracking metastatic lobular breast cancer. One scan uses a special tracer that binds to estrogen in the body, while the other uses a common tracer for glucose (sugar). Individuals with confirmed lobular breast cancer that is estrogen receptor positive (ER+) and who have already undergone a biopsy might be suitable candidates. As a Phase 2 trial, this research measures the effectiveness of the scans in an initial, smaller group, providing participants an opportunity to contribute to advancements in breast cancer detection.

Do I need to stop my current medications for the trial?

If you are on adjuvant ER-blocking endocrine therapy, you need to stop it for 8 weeks if it's a SERM or 24 weeks if it's a SERD before joining the trial. Aromatase inhibitors or ovarian suppression medications are allowed.

What prior data suggests that these imaging techniques are safe for detecting and monitoring metastatic ILC?

Research has shown that 18F-Fluoroestradiol (FES) PET/CT scans are generally safe for people. The United States approved this imaging method in 2020 for patients with certain types of breast cancer, indicating it passed important safety checks and is well-tolerated.

Previous studies have not identified major safety issues with FES PET/CT scans. These scans use a special imaging technique to detect cancer cells and have been used in breast cancer patients without significant problems. Its approval for similar uses suggests it is safe for patients.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different imaging approaches specifically for lobular breast cancer, a subtype that often poses challenges when using standard imaging techniques. Unlike the more common ductal breast cancer, lobular breast cancer can grow in a pattern that’s harder to detect with traditional imaging like mammograms or ultrasounds. This trial aims to identify imaging techniques that could improve the detection and monitoring of lobular breast cancer, potentially leading to more accurate diagnoses and better-tailored treatment plans. By honing in on these specialized imaging methods, the trial could pave the way for advancements that significantly enhance patient outcomes for those with this particular type of breast cancer.

What evidence suggests that these imaging scans are effective for detecting and monitoring metastatic ILC?

Research has shown that 18F-Fluoroestradiol (FES) PET/CT scans effectively find and track estrogen receptor-positive (ER+) invasive lobular carcinoma (ILC), a type of breast cancer. In this trial, participants with biopsy-proven metastatic ILC will undergo FES-PET/CT scans. Studies have demonstrated that FES-PET/CT can successfully identify where ILC has spread in the body. Specifically, one study detected cancer in both bones and other areas. This method might better reveal the extent of cancer spread compared to standard methods. Overall, FES-PET/CT is a promising tool for evaluating breast cancer, especially when the cancer spreads to different parts of the body.16789

Who Is on the Research Team?

SG

Somali Gavane, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

My cancer, identified through a biopsy, has spread from the breast.
My cancer is not HER2 positive according to ASCO/CAP guidelines.
I am able to get out of my bed or chair and move around.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo PET/CT scans using 18F-FES and 18F-FDG to compare imaging approaches

1 year

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • 18F-Fluoroestradiol PET/CT

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Biopsy-proven ER+ Metastatic Invasive Lobular Carcinoma/ILCExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Citations

Staging Invasive Lobular Carcinoma: A Prospective Study ...

This prospective trial evaluated [18F]Fluoroestradiol (FES)-PET/CT for staging ER+ invasive lobular carcinoma (ILC) in 25 patients. FES-PET/CT ...

[18F]Fluoroestradiol-PET/CT Imaging of Invasive Lobular ...

Multiple studies have proven the efficacy of FES-PET/CT for imaging evaluation of ER+ invasive breast malignancy (evaluating both IDC and ILC together, with the ...

Fluoroestradiol PET (FES-PET) and [18 ...

Our findings suggest that both FES-PET and FDG-PET can identify metastatic ILC and be useful in detecting the pattern and extent of disease.

Can 18 F-FES PET Improve the Evaluation of 18 F-FDG ...

Among 20 ILC patients, 65 nonbone lesions were found to be distributed in 13 patients, and 16 patients were diagnosed with bone metastasis, which was ...

Comparative analysis of FES-PET/CT and FDG- ...

Can 18F-FES PET improve the evaluation of. 18F-FDG PET in patients with metastatic invasive lobular carcinoma? Clin Nucl. Med 2024;49:301–7 ...

Prospective Pilot Study of 18F-Fluoroestradiol PET/CT in ...

The primary aim of this study was to assess the frequency with which sites of histologically proven ILC have abnormal uptake on FES PET/CT.

Update on 18F-Fluoroestradiol

18 F-FES PET/CT gained clinical approval in 2016 in France and 2020 in the United States for use in patients with ER+ metastatic or recurrent breast cancer.

Cerianna™ (fluoroestradiol F18) injection

Cerianna™ (fluoroestradiol F18) is indicated for use with PET imaging for the detection of ER+ lesions as an adjunct to biopsy in patients with recurrent or ...

Summary: Appropriate Use Criteria for Estrogen Receptor ...

The most appropriate uses of 18 F-FES PET are to assess ER functionality when endocrine therapy is considered either at initial diagnosis of metastatic breast ...