CancerIMPACTNCT04285996
IMaging Pilot Study of the αvβ6 Integrin Radiotracer [18F]-A20FMDV2 in PAtients With Solid Cancer Types
A study testing PET Scan in people with Cancer, run by Queen Mary University of London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- PET Scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Mar 2016to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The epithelial specific integrin αvβ6 is not expressed by resting epithelia (1) but is up regulated in several cancers. It has been estimated that approximately 250,000 or 15% of new cancers (excluding non-melanoma skin cancers) that arise in the UK and USA combined will overexpress αvβ6 (2-4). αvβ6 plays a key role in tumour invasion and carcinogenesis. Strong expression of αvβ6 is associated with significant reduction in life expectancy in patients with colon, cervical, breast or non-small cell lung cancer (3-5). Recently, it has been shown in preclinical studies that antibody targeting of αvβ6 could suppress the growth of oral and breast cancer human xenografts and suppress breast cancer metastasis (6). Thus αvβ6 represents a biologically relevant target for anti-cancer therapy.
The proposal is to conduct this study in patients with solid tumours as αvβ6 is expressed exclusively by carcinomas, which are all solid tumours. As the utility of [18F]-FBA-A20FMDV2 in patients with cancer has not been evaluated a particular challenge with evaluation of this radiotracer in patients with cancer include potential metabolism and excretion of this radiotracer by the liver and kidney confounding the image quality for lower thoracic and abdominal tumours requiring optimisation of the imaging protocol. In addition, as the patients are likely to be unwell, it is imperative an imaging protocol that is patient-friendly in terms of the scan duration is developed. Additionally it would be ideal to confirm that the uptake of the radiotracer is indeed due to αvβ6 expression on the cancer cells. Therefore in this study, it is planned to evaluate the feasibility of performing such a study in patients with a variety of solid tumours.
- Conditions
- Cancer
- Being tested
- PET Scan
- Keywords
- Breast Cancer, Pancreatic Cancer, Head &Neck Cancer
- Medical subject headings
- Neoplasms, Breast Neoplasms, Pancreatic Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET ScanProcedure or surgery
Also called PET imaging using [18F]-FBA-A20FMDV2
| Study group | Role | What they receive |
|---|---|---|
| All patients | Other | Pilot study: All registered patients will undergo a PET scan using [18F]-FBA-A20FMDV2. Receives: Procedure: PET Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at the time of the PET scan
Secondary outcomes (1)
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.
Measured: The outcome will be measured after each scan.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start17 Mar 2016
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Schmid, Principal investigator, Queen Mary University of LondonJohn Marshall, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285996
- Sponsor's protocol ID
- 10559QM
- Acronym
- IMPACT
- Status last verified
- Jul 2024
- First submitted
- 18 Sep 2017
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMaging Pilot Study of the αvβ6 Integrin Radiotracer [18F]-A20FMDV2 in PAtients With Solid Cancer Types
- ClinicalTrials.gov ID
- NCT04285996
- Acronym / sponsor ID
- IMPACT / 10559QM
- Conditions
- Cancer
- Keywords
- Breast Cancer, Pancreatic Cancer, Head &Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 17 Mar 2016 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The epithelial specific integrin αvβ6 is not expressed by resting epithelia (1) but is up regulated in several cancers. It has been estimated that approximately 250,000 or 15% of new cancers (excluding non-melanoma skin cancers) that arise in the UK and USA combined will overexpress αvβ6 (2-4). αvβ6 plays a key role in tumour invasion and carcinogenesis. Strong expression of αvβ6 is associated with significant reduction in life expectancy in patients with colon, cervical, breast or non-small cell lung cancer (3-5). Recently, it has been shown in preclinical studies that antibody targeting of αvβ6 could suppress the growth of oral and breast cancer human xenografts and suppress breast cancer metastasis (6). Thus αvβ6 represents a biologically relevant target for anti-cancer therapy.
The proposal is to conduct this study in patients with solid tumours as αvβ6 is expressed exclusively by carcinomas, which are all solid tumours. As the utility of [18F]-FBA-A20FMDV2 in patients with cancer has not been evaluated a particular challenge with evaluation of this radiotracer in patients with cancer include potential metabolism and excretion of this radiotracer by the liver and kidney confounding the image quality for lower thoracic and abdominal tumours requiring optimisation of the imaging protocol. In addition, as the patients are likely to be unwell, it is imperative an imaging protocol that is patient-friendly in terms of the scan duration is developed. Additionally it would be ideal to confirm that the uptake of the radiotracer is indeed due to αvβ6 expression on the cancer cells. Therefore in this study, it is planned to evaluate the feasibility of performing such a study in patients with a variety of solid tumours.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Other | Procedure: PET ScanPilot study: All registered patients will undergo a PET scan using [18F]-FBA-A20FMDV2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET ScanAlso: PET imaging using [18F]-FBA-A20FMDV2 | Procedure or surgery | All patients |
Primary outcome
To evaluate the feasibility of [18F]-FBA-A20FMDV2-PET imaging in patients with solid tumours.
Time frame: at the time of the PET scan
The uptake of the radiotracer by tumours and normal tissue
1 secondary outcome
Optimise PET scan time parameters
Time frame: The outcome will be measured after each scan.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Schmid principal investigator
Queen Mary University of London
John Marshall principal investigator
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET Scan in people with Cancer, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the feasibility of [18F]-FBA-A20FMDV2-PET imaging in patients with solid tumours. (time frame: at the time of the PET scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.