Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID05730608

Improving Breast Cancer Staging With 18F-FDG PET/CT Imaging (The IMBRECAS PET Study)

Led by Vestre Viken Hospital Trust · Updated on 2024-05-09

300

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of 18F-FDG PET/CT imaging to detect breast cancer metastases that conventional imaging methods like CT and bone scintigraphy might miss. This study focuses on women diagnosed with stage II/III or locoregional recurrent breast cancer, aiming to see if this imaging can improve disease staging and influence treatment decisions. It also explores how imaging and molecular characteristics may relate to patient outcomes such as overall survival and progression-free survival. Participants will undergo an 18F-FDG PET/CT scan in addition to the usual CT and bone scintigraphy imaging as part of their cancer assessment. The study includes patients with newly diagnosed high-risk breast cancer or suspected/proven locoregional recurrent breast cancer. The main goal is to determine if the PET/CT scan leads to changes in staging or treatment plans compared to conventional imaging alone. During the study, researchers will collect imaging data, including PET parameters and CT/MRI measurements, as well as blood and tumor samples for molecular analysis. They will monitor changes in cancer staging and management over five years, along with overall survival. Participants' health status will be assessed using the ECOG performance scale, and safety and outcomes will be followed throughout the study period, which runs until 2032.

CONDITIONS

Brief Title

18F-FDG PET/CT Imaging for Breast Cancer

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with high risk primary or recurrent breast cancer
  • Non pregnant women over 18 years old
  • Not receiving active treatment of other cancer types
  • Eastern Cooperative Oncology Group (ECOG) status 0-2
Not Eligible

You will not qualify if you...

  • Pregnant women
  • Males
  • Age under 18
  • Patients receiving active treatment for other cancers
  • Poor general condition (ECOG 3 or higher)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - 1 day

Participants undergo an 18F-FDG PET/CT scan in addition to conventional imaging to improve breast cancer staging.

1 visit (in-person)

Long-term Monitoring

Duration - 5 years

Participants are monitored for changes in cancer staging and overall survival over time.

Trial Site Locations

Total: 1 location

1

Drammen Hospital - Vestre Viken HF

Drammen, Norway, N-3004

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Research Team

H

Harald Grut, MD, PHD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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