Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT06335069

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

Led by Maastricht University Medical Center · Updated on 2025-09-24

20

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patient with histopathologically proven ER+ breast cancer
  • Diagnosed with locally advanced (primary tumor >5 cm and/or axillary lymph node metastases), recurrent, or metastatic breast cancer
  • Scheduled for 18F-FDG PET/CT or 18F-FDG PET/MRI staging
  • Willing and able to undergo study procedures
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Pregnancy
  • Secondary malignancies except non-melanoma skin cancer
  • No 18F-FDG PET/CT or PET/MRI scan performed
  • Contraindications for PET/MRI (e.g., pacemaker, aneurysm clips, metallic body device, severe claustrophobia, severe obesity)
  • Chronic inflammatory diseases such as rheumatoid arthritis
  • Severe hepatic or renal impairment (eGFR ≤45 mL/min/1.73m²)
  • Unable to provide informed consent

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Trial Site Locations

Total: 1 location

1

Maastricht University Medical Center+

Maastricht, Netherlands, 5800

Actively Recruiting

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Research Team

T

Thiemo JA van Nijnatten, MD, PhD

CONTACT

L

Lisa EHW Duijx, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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