IMaging Pilot Study of the αvβ6 Integrin Radiotracer [18F]-A20FMDV2 in PAtients With Solid Cancer Types

NCT04285996 | Completed DMC

• 1 other identifier: 10559QM
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

A substance called integrin alpha v beta six (αvβ6) is found to be increased in some cancer cells and can play an important role in the development and spread of cancer. If the levels of integrin αvβ6 in cancer cells can be measured by carrying out PET scans, we might be able to identify and potentially treat tumours. FBA-A20FMDV2 is a substance that binds or sticks to integrin αvβ6. It may therefore be possible to find and measure the amount of integrin αvβ6 in tumours. To do this a small amount of radioactivity will be attached to FBA-A20FMDV2 and carry out a scan called a Positron Emission Tomography (PET) scan. FBA-A20FMDV2 attached to radioactivity is known as \[18F\]FBA-A20FMDV2 or a radiotracer, as a very small amount of tracer dose is given to humans. So far such scans have been carried out in healthy volunteers and in patients with a lung condition called idiopathic pulmonary fibrosis (IPF). This was to assess the safety of the radiotracer and how it is taken up in the body. However, such scans have not been performed in cancer patients. This study will help specifically investigate αvβ6 in patients with cancer and find out how \[18F\]FBA-A20FMDV2 is taken up in tumours. With this information, the ideal imaging method for patients with cancer can be developed.

Conditions

Cancer

Keywords

Breast Cancer; Pancreatic Cancer; Head &Neck Cancer

Outcome Measures

Primary Outcomes (1)

• To evaluate the feasibility of [18F]-FBA-A20FMDV2-PET imaging in patients with solid tumours.

  The uptake of the radiotracer by tumours and normal tissue

  at the time of the PET scan

Secondary Outcomes (1)

• Optimise PET scan time parameters

  The outcome will be measured after each scan.

Study Arms (1)

All patients

OTHER

Pilot study: All registered patients will undergo a PET scan using \[18F\]-FBA-A20FMDV2.

Procedure: PET Scan

Interventions

PET Scan PROCEDURE

Also known as: PET imaging using [18F]-FBA-A20FMDV2

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• 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 or male aged ≥18 years
• ECOG performance status of 0-2
• Clinical diagnosis of a solid tumour measuring ≥1cm in the longest diameter as assessed by clinical imaging or by physical clinical evaluation.
• Female patients of childbearing potential or male patients with female partners of child-bearing potential must agree to use adequate contraception as described in the protocol from the day of the scan and until 4 weeks after the scan
• 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 urine pregnancy test for female patients of childbearing potential prior to study entry1.
• Availability of a formalin fixed, paraffin embedded (FFPE) tumour sample for central assessment.2

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).
• 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, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Pancreatic Neoplasms; Head and Neck Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

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: September 18, 2017
• First Posted: February 26, 2020
• Study Start: March 17, 2016
• Primary Completion: July 15, 2022
• Study Completion: July 15, 2022
• Last Updated: July 8, 2024

Record last verified: 2024-07

Locations

GB (1)