18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2027-03-31

Brief Summary

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The extent of breast cancer is an important prognostic factor in patients diagnosed with this disease. Therefore, adequate staging at diagnosis is a requisite for optimal treatment. In all patients diagnosed with locally advanced breast cancer (LABC), distant staging using 18F-FDG PET/CT is recommended. However, the degree of metabolic uptake in the primary breast tumor is significantly lower in the ER+ subtype compared to HER2+ and triple negative breast cancer (TNBC). As a consequence, a suboptimal 18F-FDG uptake in ER+ breast cancer patients can potentially lead to missed distant metastases. Fibroblast-activating protein inhibitor (FAPI) is a recently developed radiotracer that binds to FAP, a stromal antigen overexpressed in more than 90% of epithelial-derived tumors and their metastases. Previous studies all show 68Ga-FAPI PET/CT to have a higher detection rate compared to 18F-FDG PET/CT. However, all previous studies were performed without considering breast cancer subtype. If the metabolic uptake by 68Ga-FAPI-46 is higher in ER+ breast cancer patients, more lesions will be detected, resulting in a more appropriate treatment for these patients. Therefore, in this pilot study, the investigators aim to compare the diagnostic performance of 18F-FDG with 68Ga-FAPI-46 as PET-tracer in ER+ breast cancer patients.

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Detailed Description

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Conditions

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Breast Cancer Breast Neoplasms Breast Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single-group, single-center pilot study

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Additional 68Ga-FAPI-46 PET/CT and PET/MRI exam

All participating patients will undergo an additional 68Ga-FAPI- 46 PET/CT and 68Ga-FAPI-46 PET/MRI scan prior to their breast cancer treatment.

Group Type EXPERIMENTAL

68Ga-FAPI-46 PET/CT and 68Ga-FAPI-46 PET/MRI

Intervention Type DIAGNOSTIC_TEST

All participating patients will undergo an additional 68Ga-FAPI- 46 PET/CT and 68Ga-FAPI-46 PET/MRI scan prior to their breast cancer treatment.

Interventions

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68Ga-FAPI-46 PET/CT and 68Ga-FAPI-46 PET/MRI

All participating patients will undergo an additional 68Ga-FAPI- 46 PET/CT and 68Ga-FAPI-46 PET/MRI scan prior to their breast cancer treatment.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Female patient with histopathologically proven ER+ breast cancer.
* Diagnosed with locally advanced (primary tumor \>5 cm and/or presence of axillary lymph node metastases) or recurrent breast cancer, or metastatic breast cancer for which 18F-FDG PET/CT or 18F-FDG PET/MRI staging is performed.
* Willing and able to undergo the study procedures.
* Has personally provided written informed consent.

Exclusion Criteria

* Age \<18
* Pregnancy
* Patients with secondary malignancies (except non-melanoma skin cancer)
* No 18F-FDG PET/CT or 18F-FDG PET/MRI scan.
* Contra-indications for PET/MRI such as pacemaker, aneurysm clips, metallic device in their body, severe claustrophobia, and severe obesity
* Chronic inflammatory disease such as rheumatoid arthritis.
* Patients with severe hepatic or renal impairment (eGFR ≤45mL/min/1.73m²)
* Inability to provide informed consent.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No