18F-FDG PET/CT Imaging for Breast Cancer

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

Purpose To investigate the ability of 18F-FDG PET/CT imaging to detect metastases not detected by conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II/III and locoregional recurrent breast cancer (BC) which can affect the choice of treatment.

Hypothesis The hypothesis is that 18F-FDG PET/CT can provide information about disease stage beyond the currently used conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II/III or locoregional recurrent BC.

Objectives

Primary:

To evaluate if a 18F-FDG PET/CT scan in the initial work up of patients diagnosed with stage II/III or locoregional recurrent BC will lead to change in staging and/or treatment.

Secondary:

• Overall survival (OS) and progression-free survival (PFS) in the patients with upstaging based on findings on 18F-FDG PET/CT scan compared with the patients with unchanged stage of disease following 18F-FDG PET/CT.
• Obtain size of the primary BC from CT/MRI scan and evaluate if these metrics are correlated to outcome.
• Obtain PET parameters from the primary BC: maximum, mean, and peak standardized uptake value (SUVmax, SUVmean, SUVpeak), metabolic tumour volume (MTV), total lesion glycolysis (TLG), total MTV and total TLG and evaluate if these metrics are correlated with outcome.
• Obtain CT and PET texture parameters from the primary BC and evaluate if these metrics are correlated with outcome.
• Blood and tumor samples for molecular characterisation:

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer Recurrent; Breast Cancer Female
• Intervention / Treatment: Other: 18F-FDG PET/CT

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Harald Grut, MD, PHD; Phone Number: 004797108503; Email: harald.grut@gmail.com

Study Locations

• Norway
  • Drammen, Norway, N-3004
    • Recruiting
    • Drammen Hospital - Vestre Viken HF
    • Contact: Harald Grut, MD, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Primary breast cancer; Patients diagnosed with new breast cancer determined to have "high risk" disease by a multidisciplinary team.	Other: 18F-FDG PET/CT; Included breast cancer patients will undergo a 18F-FDG PET/CT scan in addition to conventional imaging with CT and bone scintigraphy.
Other: Recurrent breast cancer; Patients with suspected or proven locoregional recurrent breast cancer.	Other: 18F-FDG PET/CT; Included breast cancer patients will undergo a 18F-FDG PET/CT scan in addition to conventional imaging with CT and bone scintigraphy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in staging and/or management due to added 18F-FDG PET/CT scan	Percentage of the patients with change in staging and/or management	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Survival after 18F-FDG PET/CT scan	5 years

Collaborators and Investigators

• Sponsor: Vestre Viken Hospital Trust
• Investigators: Principal Investigator: Harald Grut, MD, PHD, Vestre Viken Hospital Trust

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2023
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 16, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: 495077

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD available by request (Harald Grut, harald.grut@gmail.com)
• IPD Sharing Time Frame: 10.02.23 to 31.12.32
• IPD Sharing Access Criteria: IPD available by request (Harald Grut, harald.grut@gmail.com)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No