NCT06978478

An Imaging Study in ER Negative Breast Cancer by Targeting αvβ6

An Imaging Feasibility Study in Oestrogen Receptor Negative MEtastatic Breast Cancer by Targeting Integrin Alpha -v Beta 6

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Queen Mary University of London · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicentre, pilot study that aims to determine the feasibility of \[18F\]-FBA-A20FMDV2-PET CT scans to detect levels of αvβ6 in patients with ER-ve αvβ6-positive metastatic or locally advanced breast cancer. A combination of factors will be used to determine the feasibility of \[18F\]-FBA-A20FMDV2-PET CT imaging including visual adequacy of the PET CT image, adequate signal to noise ratio and the ability to evaluate the image differential between the metastatic lesion(s) and normal tissue.

Detailed description

Integrin alpha v beta six (αvβ6) is present in increased amounts on a number of cancer cells and is known to play a prominent role in cancer development and spread. FBA-A20FMDV2 is a substance that sticks to αvβ6. It may therefore be possible to identify and measure the amount of αvβ6 in tumours by attaching a small amount of radioactivity to FBAA20FMDV2 and carrying out a scan called a PET scan. FBA-A20FMDV2 attached to radioactivity is known as \[18F\]-FBAA20FMDV2 or a radiotracer, where very small amount of tracer doses are given to man. Such scans have been carried out in healthy volunteers and patients with a lung condition to assess radiotracer safety and specificity. IMETAB6 will help to find out how \[18F\]-FBA-A20FMDV2 is taken up in tumours in breast cancer patients where their cancer has spread (metastasised) to other parts of the body. This information will be used to develop the ideal imaging method for cancer patients where their disease has metastasised. 20 women with hormone (oestrogen) receptor (ER)-negative breast cancer whose tumours contain αvβ6, measure ≥1cm in diameter, and whose cancer has metastasised, will be on the study for 4 weeks. These women will give blood samples and undergo one \[18F\]-FBA-A20FMDV2-PET scan, and one 'control' scan without FBA-A20FMDV2 (an FDG-PET scan) for comparison, to see if tumours containing αvβ6 can be detected. Participants will be called within 3 days following their \[18F\]-FBA-A20FMDV2-PET scan to check their wellbeing. All patients will be recruited from Barts Health NHS Trust oncology clinics, where they will undergo an \[18F\]-FDG-PETCT scan. They will then undergo the \[18F\]-FBA-A20FMDV2-PET scan at Imanova Centre for Imaging Sciences. αvβ6 levels will be measured on patient tumour samples as part of their normal clinical care and a small sample (biopsy) of their metastasis will be analysed for αvβ6.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Unlabelled PET CT Scan	\[18F\]-FDG-PET CT
PROCEDURE	Labelled PET CT Scan	\[18F\]-FBA-A20FMDV2 -PET CT

Timeline

• Start date: 2018-06-19
• Primary completion: 2020-07-27
• Completion: 2020-07-27
• First posted: 2025-05-18
• Last updated: 2025-05-18

Locations

1 site across 1 country: United Kingdom