Cancer Clinical Trial
— IMPACTOfficial title:
IMaging Pilot Study of the αvβ6 Integrin Radiotracer [18F]-A20FMDV2 in PAtients With Solid Cancer Types
Verified date | February 2020 |
Source | Queen Mary University of London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 12 |
Est. completion date | May 2020 |
Est. primary completion date | May 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Able to give written informed consent prior to admission to this study. 2. Female or male aged =18 years 3. ECOG performance status of 0-2 4. Clinical diagnosis of a solid tumour measuring =1cm in the longest diameter as assessed by clinical imaging or by physical clinical evaluation. 5. 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 6. 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. 7. Negative urine pregnancy test for female patients of childbearing potential prior to study entry1. 8. Availability of a formalin fixed, paraffin embedded (FFPE) tumour sample for central assessment.2 Exclusion Criteria: 1. Breast feeding female patients. 2. Previous or current exposure to animals that may harbour the foot and mouth disease virus FMDV2 3. Previous long-term (= 3 months) residence in a country where FMDV2 is endemic (such as certain areas of Africa, Asia and South America). 4. Subject feels unable to lie flat and still on their back for a period of up to 95 minutes in the PET/CT scanner. 5. 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Barts Health NHS Trust | London |
Lead Sponsor | Collaborator |
---|---|
Queen Mary University of London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Optimise PET scan time parameters | Timing of radiotracer administration will be measured in tumour and normal tissue. Results will be presented by Time Activity Curves. | The outcome will be measured after each scan. |
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