FDG-PET/CT versus conventional CT for response monitoring in metastatic breast cancer: A pilot study for a randomized clinical trial (MONITOR-PILOT)

Phase 1

Recruiting

Conditions: Metastatic breast cancer
Therapeutic area: Diseases [C] - Neoplasms [C04]
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Registration Number: CTIS2023-506550-20-00

Lead Sponsor: Odense University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Women and men aged=18 years, Diagnosis of distant relapsed MBC (biopsy-verified) or de novo breast cancer (biopsy verification of primary tumor and disseminated disease at baseline scan), Considered eligible for first-line systemic treatment, Considered eligible for continuous treatment monitoring by scans, Signed informed consent, Ability to read and understand Danish language

Exclusion Criteria

Pregnant or lactating women, Ongoing oncological treatment for another cancer, Exclusively brain metastasis, Allergy to FDG

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the MONITOR-RCT is to demonstrate that in patients with metastatic breast cancer, response monitoring based on FDG-PET/CT is superior to response monitoring based on CT with respect to overall survival. The objective will be based on applying standardized response evaluation criteria, using an appropriate adaptation of the PERCIST criteria for FDG-PET/CT and the RECIST1.1 criteria for CT.;Secondary Objective: Secondary objectives of the MONITOR-RCT are to demonstrate superiority with respect to the quality of life and time and exposure to treatment and to investigate the cost-effectiveness and the occurrence of adverse events.;Primary end point(s): Overall survival

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Quality of life;Secondary end point(s):Time and exposure to treatment;Secondary end point(s):Cost-effectiveness;Secondary end point(s):Occurrence of adverse events