18F-FDG PET/CT Imaging for Breast Cancer

Breast Cancer Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05730608
• Other study ID #: 495077
• Status: Recruiting
• Phase: N/A
• Start date: February 16, 2023
• Est. completion date: December 31, 2032

Study information

• Verified date: May 2024
• Source: Vestre Viken Hospital Trust
• Contact: Harald Grut, MD, PHD
• Phone: 004797108503
• Email: harald.grut[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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:

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2032
• Est. primary completion date: December 31, 2032
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Cancer Recurrent
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Norway	Drammen Hospital - Vestre Viken HF	Drammen

Sponsors (1)

Lead Sponsor	Collaborator
Vestre Viken Hospital Trust

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival	Survival after 18F-FDG PET/CT scan	5 years