BRIANSTORM - Early Identification of Patients With Brain Metastases

Active, not recruiting

• Conditions: Metastatic Rectal Adenocarcinoma; Brain Metastases

• Registration Number: NCT05185557
• Lead Sponsor: Aarhus University Hospital

Brief Summary

A single arm observational study investigating the incidence of brain metastasis in patients with cancer recti and lung metastasis

Detailed Description

In this study the investigators want to investigate the incidence of brain metastasis in a selected high-risk group of patients with metastatic colorectal cancer. Possible prognostic biological aspects will be investigated by translational analysis of biological samples. The study population consists of patients with metastatic rectal cancer and presence of lung metastasis. The patients will undergo a standard MRI scan of the brain including injection of intravenous contrast. If positive finding, images will be evaluated at the multidisciplinary tumor board for potential treatment options according to clinical practice. Standard follow-up program is followed, as per clinical practice. If the initial MRI scan of cerebrum detects brain metastasis this will be treated and followed as per clinical practice. Translational blood samples will be drawn at inclusion and at every imaging schedule up til 5 times

Study Timeline

• Study Start: 2021-08-16
• Study First Submitted: 2021-12-16
• Study First Submitted QC: 2022-01-06
• Study First Posted: 2022-01-11
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-02
• Last Update Posted: 2023-02-03
• Primary Completion: 2023-08
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Primary rectal tumor location

  • Diagnosis of lung metastasis made by histo- or cytopathology, or by clinical and imaging criteria.
  • Able to understand written information
  • Consent to samples for translational research

Exclusion Criteria

• Contraindications for MRI Priorly treated or known brain metastases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of brain metastasis	2 years	Incidence of brain metastasis in a high risk selected group

Secondary Outcome Measures

Name	Time	Method
Number of brain metastases eligible for local treatment options	2 years	Number of brain metastases eligible for local treatment options
Prognostic value of circulating DNA levels at baseline	2 years last patient
Descriptive biological analysis of tumor tissue and circulating tumor DNA	2 years last patient
Median two year overall survival	2 years last patient	Median two year overall survival

Trial Locations

Locations (1)

Department of Oncology, Aarhus University Hospital; 🇩🇰 Aarhus N, Denmark