Recruiting PHASE2 Breast Cancer

Compares treatment options for Breast Cancer

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

ClinicalTrials.gov ID: NCT06335069

What this study is testing

What it's testing
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.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older, women only

You may be able to join if

  • 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...
  • Willing and able to undergo the study procedures.
  • Has personally provided written informed consent.

You likely can't join if

  • 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.
See the full eligibility criteria
Who can join
  • 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...
  • Willing and able to undergo the study procedures.
  • Has personally provided written informed consent.
What rules you out
  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Maastricht, Netherlands

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Maastricht, Netherlands. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.