Table of Contents
- Trial overview
- Who was studied
- What the trial measured
- Study design and phase
- Key trial result focus
- Patient terms explained
Trial overview
The available study of 68Ganota-Anti-Her2 Vhh1 was an interventional trial in cancer patients with brain metastasis.[1] It was designed to compare the uptake of the study agent in brain metastasis lesions from HER2-positive and HER2-negative patients.[1]
The trial was completed and enrolled 30 participants.[1] It was listed as Phase 2.[1]
Who was studied
The study focused on people with cancer that had spread to the brain, which is called brain metastasis.[1] The trial summary says the comparison was between HER2-positive and HER2-negative patients, so the research included both groups.[1]
This means the trial was not looking at a broad cancer population, but at a more specific group with brain lesions that could be seen on imaging.[1]
What the trial measured
The main outcome was the tumor targeting potential in brain metastasis.[1] This was checked in two ways: first by a doctor scoring the scan as positive or negative, and second by measuring Standard Uptake Values (SUV).[1]
SUV is a number used in imaging to show how much of the tracer is seen in the lesion.[1] In this trial, the physician who read the scans was unaware of HER2 status, which helps reduce bias in the assessment.[1]
Study design and phase
This was an interventional study, which means participants received the study intervention and the researchers measured the results.[1] The phase was Phase 2, a stage that usually examines performance in a defined patient group after earlier testing.[1]
The intervention was listed as 68Ga-NOTA-anti-HER2 VHH1 given by intravenous administration at 185 MBq.[1] The trial data do not provide other treatment details beyond this study administration.[1]
Key trial result focus
The brief summary shows that the main goal was to compare uptake of 68GaNOTA-Anti-HER2 VHH1 in brain metastasis lesions from HER2-positive and HER2-negative patients.[1] So the trial was focused on imaging performance, not on treating the cancer itself.[1]
Because the assessment was based on scan appearance and SUV measurement, the study aimed to see whether the tracer could help show tumor lesions more clearly in the brain.[1]
Patient terms explained
Interventional means the researchers gave a study product and then measured what happened.[1] Completed means the trial has finished collecting the planned information.[1]
HER2 status is a label used to separate cancers into HER2-positive and HER2-negative groups.[1] In this study, that label was used to compare how the imaging signal looked in each group.[1]
