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Not yet recruiting NCT07627269

Late Scan Time-point Optimalisation of 18F-Fluoroestradiol for the Large Field-of-view (LAFOV) PET/CT Scanner.

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Late scan time-point(s) optimalisation of 89Zr trastuzumab18F-Fluoroestradiol.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Currently, in routine patient care PET/CT scan protocols used on high sensitivity large field of-view (LAFOV) PET/CT systems are based on protocols that historically were developed for standard field-of-view (SAFOV) PET/CT systems with a much lower sensitivity profile. In the current SAFOV-based imaging protocols, the maximum delay between injection and actual scanning is limited by increasing noise (due to radioactive decay) resulting in bad image quality. A major advantage of later time-point imaging in general is, that the target-to background ratio improves. With the high-sensitive LAFOV PET/CT scanner later time-point imaging becomes possible, and higher tumour-to background ratios can be obtained. Specifically for the 18F-Fluoroesradiol tracer, used to image estrogen receptor positive tumors, high physiological uptake in the liver and intestines hampers the visualization and quantification of liver metastases and peritoneal metastases. The aim of this study is to evaluate whether late time point imaging with the 18F-Fluoroestradiol tracer on the LAFOV PET/CT improves visualization and quantification of liver metastases and peritoneal metastases.

Interventions

  • Radiation Late scan time-point(s) optimalisation of 89Zr trastuzumab18F-Fluoroestradiol
    Patients who consent in participating will be scanned at one to two additional time-point(s) after injection, at a time-point that is later than the one currently used in practice.

Primary outcome measures

  • The primary outcome measure is the sensitivity/specificity of FES PET for liver metastases and peritoneal metastases, using conventional CT as gold standard. [Time frame: Day 1]

Eligibility criteria

Inclusion criteria

  • Patients who are referred for PET/CT imaging with 18F-Fluoroestradiol will be included in this study.

Exclusion criteria

  • Patients who are not able to lay down in supine position for up to one hour.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Netherlands · 1 center
  • University Medical Center Groningen — Groningen

Identifiers

NCT: NCT07627269 · 23995

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗