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Not yet recruitingPhase 2

Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET

Improving Detection and Outcomes in Patients With Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAPI PET Imaging

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: PET scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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 rates, and PET lesion intensity, as well as to assess the clinical value of the PET scans from the treating physician's and the patient's perspective."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study compares a new FAPI-74 PET/CT scan with the standard FDG PET/CT scan in 15 women with invasive lobular breast cancer that has spread to other parts of the body. Each woman will have both scans to see how well they find cancer and how useful they are to patients and doctors.

This study is a pilot clinical imaging trial of a prospective, head-to-head comparison of 18F-Fibroblast Activation Protein Inhibitor (FAPI)-74 PET/CT versus standard-of-care 18F-Fluorodeoxyglucose (FDG) PET/CT in 15 patients with metastatic invasive lobular breast cancer (ILC). 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 rates, and PET lesion intensity, as well as to assess the clinical value of the PET scans from the treating physician's and the patient's perspective.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign and date a form agreeing to join the study.
  • Be willing to follow all study steps and lifestyle rules, and be available for the whole study.
  • Be female and older than 18.
  • Have invasive lobular breast cancer, with lab testing of tissue confirming that it has spread to other parts of the body.
  • Have an ECOG score of 0–2: be able to care for yourself and be out of bed for more than half of your waking hours.
  • Have no planned change in cancer treatment between the two scans.

Who can't join

  • Be pregnant or breastfeeding.
  • Be unable to have a PET/CT scan.
  • Have blood levels of bilirubin or creatinine more than 1.5 times the highest normal level. These tests help check liver and kidney health.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study * Females; Age \> 18 years of age * Diagnosis of invasive lobular breast cancer, with pathologically confirmed metastatic disease. * ECOG performance status 0-2 * No planned change in anticancer therapy between FDG and FAPI PET scans Exclusion Criteria: * Patients who are pregnant or lactating * Patients who cannot undergo PET/CT scanning * Patients with total serum bilirubin or serum creatinine \> 1.5 times the upper limit of normal

Study sites (1)

NY