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

NCT07627269 | Not Yet Recruiting

• 1 other identifier: 23995
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is the sensitivity/specificity of FES PET for liver metastases and peritoneal metastases, using conventional CT as gold standard.

  Day 1

Study Arms (1)

Extra PET/CT scan at 1 to 2 additional, later time-point(s) after injection than current practice

EXPERIMENTAL

Radiation: Late scan time-point(s) optimalisation of 89Zr trastuzumab18F-Fluoroestradiol

Interventions

Late scan time-point(s) optimalisation of 89Zr trastuzumab18F-Fluoroestradiol RADIATION

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.

Extra PET/CT scan at 1 to 2 additional, later time-point(s) after injection than current practice

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9717GZ, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: June 4, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: June 4, 2026

Record last verified: 2026-05

Locations

NL (1)