An Imaging Study in ER Negative Breast Cancer by Targeting αvβ6

NCT06978478 | Withdrawn

• 1 other identifier: 010954QM
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Uptake of [18F]FBA-A20FMDV2 in tumours expressed as standardised uptake value

  Imaging results will be continuously assessed before proceeding to the next patient and the timing of the radiotracer administration in relation to the scan start will be varied to optimise image acquisition.

  Through study completion of 4 weeks - Study withdrawn and no further information

Secondary Outcomes (3)

• Concordance between [18F]-FBA-A20FMDV2-PET CT scans and [18F]-FDG-PET CT scans.

  Through study completion of 4 weeks - Study withdrawn and no further information]

• Correlate [18F]-FBA-A20FMDV2-PET CT uptake measures with standard IHC expression in metastatic tumour samples.

  Through study completion of 4 weeks - Study withdrawn and no further information]

• Change in αvβ6 expression levels in primary and metastatic tumour samples by IHC.

  Through study completion of 4 weeks - Study withdrawn and no further information]

Study Arms (1)

All patients

EXPERIMENTAL

Pilot study: All registered patients will undergo 2 CT PET scans.

Procedure: Unlabelled PET CT Scan; Procedure: Labelled PET CT Scan

Interventions

Unlabelled PET CT Scan PROCEDURE

\[18F\]-FDG-PET CT

All patients

Labelled PET CT Scan PROCEDURE

\[18F\]-FBA-A20FMDV2 -PET CT

All patients

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to give written informed consent prior to admission to this study.
• Female aged ≥18 years.
• ECOG performance status of 0-2.
• Histologically confirmed ER-ve metastatic or locally advanced breast cancer (latest available sample). ER-ve status defined as \<1% of tumour cells positive for ER on IHC or IHC score (Allred) ≤2. Any HER2 status is acceptable.
• At least one metastatic tumour site measuring ≥1cm in the longest diameter (except lymph nodes which must have a short axis of ≥1.5cm) as assessed by clinical imaging or by physical clinical evaluation.
• Biopsiable metastatic or locally advanced tumour sites, if a FFPE sample of current metastatic sites is not available. If an FFPE sample from the current metastatic sites is not available then patients must be willing to undergo an US or CT guided biopsy.
• Available FFPE tumour sample of the primary tumour prior to study entry for central assessment.
• Known αvβ6 status on primary or metastatic tumour (latest available) as defined by IHC.
• Patient must be progressing on current anti-cancer treatment (non-responder).
• Haematologic indices (FBC, WBC, ANC, platelets count and haemoglobin) and biochemical indices (sodium, potassium, chloride, urea, creatinine, total protein, albumin, total bilirubin, ALP and AST) within local institutional limits.
• Negative serum or urine pregnancy test for female patients of childbearing potential prior to study entry . Female patients of childbearing potential must agree to use adequate contraception as described in the protocol from the day of the scan and until 4 weeks after the last scan.

You may not qualify if:

• Breast-feeding female patients.
• Previous or current exposure to animals that may harbour the foot and mouth disease virus FMDV2
• Previous long-term (≥ 3 months) residence in a country where FMDV2 is endemic (such as certain areas of Africa, Asia and South America).
• Planned to receive further anti-cancer treatment while on study.
• Subject feels unable to lie flat and still on their back for a period of up to 95 minutes in the PET/CT scanner.
• Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of the tracer, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Barts Health NHS Trust

London, EC1M 6BQ, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Peter Schmid

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

• John Marshall

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: May 18, 2025
• Study Start: June 19, 2018
• Primary Completion: July 27, 2020
• Study Completion: July 27, 2020
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)