Breast Neoplasm FemaleBreast PETNCT03198442
Breast PET Feasibility
A study testing F-18 FDG breast PET scan in people with Breast Neoplasm Female, run by University College, London at 1 site in United Kingdom.
Trial summary
Breast PET may be able to help in the diagnostic pathway in patients to determine which ones need to go on to have a second look ultrasound +/- biopsy and those who need to be sent for MRI guided biopsy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm Female
- What is being tested?
- F-18 FDG breast PET scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Oct 2016to 4 Mar 2019
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age over 18 (no upper limit).
- Not pregnant.
- Not breastfeeding.
- Indeterminate breast lesion on MRI requiring a second-look ultrasound.
- Ability to lie still for up to 30 minutes prone and supine.
- Females of childbearing potential have a negative pregnancy test within 7 days prior to being registered. Participants are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
- Willing and able to provide written informed consent.
Who cannot join
- Females who are pregnant, planning pregnancy or breastfeeding
- Concurrent and/or recent involvement in other research that is likely to interfere with the intervention within 3 months prior to study enrolment
- Inability to lie flat or undergo the tests.
- Any co-morbidities or conditions which in the opinion of the clinical team means that the patient should be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Dedicated Breast PET in the Characterisation of Indeterminate Breast Lesions on MRI Requiring a Second-look Ultrasound - a Feasibility Study
Breast PET may be able to help in the diagnostic pathway in patients to determine which ones need to go on to have a second look ultrasound +/- biopsy and those who need to be sent for MRI guided biopsy. This may reduce the need to create more anxiety and uncertainty in this group of patients, already extremely stressed by the recent diagnosis of breast cancer.This study involves a single trial visit the Royal Free Hospital for imaging. Participants will need to lie flat for up to 30 minutes on the PET-CT camera and up to 30 minutes on the MAMMI. They will be advised not to take part in this study if they are unable to lie flat on their back and their front for this length of time or if they are claustrophobic. They will be offered the opportunity to see the PET-CT scanner and the MAMMI before deciding to consent to the trial.
Read the detailed description
This study involves a single trial visit the Royal Free Hospital for imaging. Participants will need to lie flat for up to 30 minutes on the PET-CT camera and up to 30 minutes on the MAMMI. They will be advised not to take part in this study if they are unable to lie flat on their back and their front for this length of time or if they are claustrophobic. They will be offered the opportunity to see the PET-CT scanner and the MAMMI before deciding to consent to the trial.
Participants will be exposed to a radiation dose from the radioactive tracer F-18 FDG that is injected into the vein before the scan and from the CT exposures during the scan. The dose associated with the injection of about 3 MBq/kg of F-18 FDG is in the range of 4-7mSv. A CT will be performed over the thorax to allow attenuation correction of PET images and localisation of tracer uptake. The dose from the thorax CT will be patient dependent but the mean dose to a patient undergoing this type of scan is 2.1mSv. A whole body CT will be performed from the base of the skull to mid-thigh to plan the bed positions for the whole body emission scan and to allow attenuation correction of PET images and localisation of tracer uptake. The dose from the whole body CT will be patient dependent but the mean dose to a patient undergoing this type of scan is 5.2mSv.The total radiation dose participants will be exposed to is in the range of 11.3-14.3mSv. This is equivalent to 4-5.3 years of background radiation to which individuals in the UK are regularly exposed. This would amount to an increased lifetime risk of cancer of approximately 1 in 1250 in a standard population. These risks are compared to a normal lifetime risk of cancer of 1 in 3.
The half-life of F-18 is 110 minutes. The duration of the scan will be up to 120 minutes post injection. The activity within the patient will have reduced by more than 50% through radioactive decay alone by the time they leave the department and will be further reduced by excretion in urine. As with standard clinical administration of F-18, patients will not need to follow any special restrictions once leaving the department.
The CT scanning protocols used in the trial PET-CT are the standard clinical protocols used in the nuclear medicine department and have been developed with a view to minimising the dose to the patient as far as possible. All women of childbearing potential will undergo a pregnancy test on the day of the scan before the injection of the radioactive tracer in order to rule out any risk to a potential foetus. Any woman of childbearing potential who is found to be pregnant or will not consent to a pregnancy test will be excluded from the trial.
Very rarely, individuals may develop an allergic reaction to the PET tracer. No serious adverse reactions to this tracer have been reported. Patients may experience some discomfort from having a needle inserted into their arm/hand in order to have the tracer injected. Occasionally the vein may become inflamed or infected, or they may experience bruising at the insertion site. All efforts will be made to avoid or minimise any discomfort or other adverse effects from these procedures.
- Conditions
- Breast Neoplasm Female
- Being tested
- F-18 FDG breast PET scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-18 FDG breast PET scanProcedure or surgery
Also called MAMMI
| Study group | Role | What they receive |
|---|---|---|
| Breast PET | Experimental | PET imaging of breast with patient in prone position. Receives: Procedure: F-18 FDG breast PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
To assess the feasibility and acceptability to patients of F-18 FDG breast PET scans, by determining how many patients can be recruited over two years.
Measured: Two years.
Secondary outcomes (4)
Comparison with standard-of-care assessments
To compare results of breast PET to ultrasound, breast MRI and pathology
Measured: Two weeks
Eligibility barriers to recruitment
To determine which eligibility criteria are barriers to recruitment of patients to a study of F-18 FDG breast PET scans.
Measured: Two years.
Comparison with whole-body PET
To compare the results obtained from F-18 FDG PET CT and breast PET scans
Measured: Two weeks
Sample size calculation
To estimate outcome standard deviations to inform sample size calculations for a definitive trial.
Measured: Two years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start5 Oct 2016
- Primary completion4 Mar 2019
- Study completion4 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Neoplasm FemaleStudies of the same condition, open and under way.
- More trials run by University College, 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Small cohort.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Free Hospital NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Thomas Wagner, Principal investigator, Royal Free Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198442
- Sponsor's protocol ID
- 9702 Breast PET Feasibility
- Other IDs
- 16/LO/0507
- Acronym
- Breast PET
- Status last verified
- Mar 2020
- First submitted
- 16 Mar 2017
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All requests for data sharing will adhere to the UCL Surgical \& Interventional Trials Unit (SITU) data sharing agreement policy. UCL Medical School is supportive of data sharing and will endeavour to assist in requests for data sharing. These data will be held on secure servers and will not be released to any third parties until all the main outputs from the studies have been published. All requests for access to the data will be formally requested through the use of a SITU data request form which will state the purpose, analysis and publication plans together with the named collaborators. All requests are dealt with on a case by case basis by SITU and the Chief Investigator. All requests will be logged and those successful will have a data transfer agreement which will specify appropriate acknowledgement of the Chief Investigator and study group, the sponsor, and funders.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Dedicated Breast PET in the Characterisation of Indeterminate Breast Lesions on MRI Requiring a Second-look Ultrasound - a Feasibility Study
- ClinicalTrials.gov ID
- NCT03198442
- Acronym / sponsor ID
- Breast PET / 9702 Breast PET Feasibility
- Conditions
- Breast Neoplasm Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Royal Free Hospital NHS Foundation Trust
- Study start
- 5 Oct 2016 (actual)
- Primary completion
- 4 Mar 2019 (actual)
- Study completion
- 4 Mar 2019 (actual)
- First posted
- 26 Jun 2017 (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.
Breast PET may be able to help in the diagnostic pathway in patients to determine which ones need to go on to have a second look ultrasound +/- biopsy and those who need to be sent for MRI guided biopsy. This may reduce the need to create more anxiety and uncertainty in this group of patients, already extremely stressed by the recent diagnosis of breast cancer.This study involves a single trial visit the Royal Free Hospital for imaging. Participants will need to lie flat for up to 30 minutes on the PET-CT camera and up to 30 minutes on the MAMMI. They will be advised not to take part in this study if they are unable to lie flat on their back and their front for this length of time or if they are claustrophobic. They will be offered the opportunity to see the PET-CT scanner and the MAMMI before deciding to consent to the trial.
Detailed description
This study involves a single trial visit the Royal Free Hospital for imaging. Participants will need to lie flat for up to 30 minutes on the PET-CT camera and up to 30 minutes on the MAMMI. They will be advised not to take part in this study if they are unable to lie flat on their back and their front for this length of time or if they are claustrophobic. They will be offered the opportunity to see the PET-CT scanner and the MAMMI before deciding to consent to the trial.
Participants will be exposed to a radiation dose from the radioactive tracer F-18 FDG that is injected into the vein before the scan and from the CT exposures during the scan. The dose associated with the injection of about 3 MBq/kg of F-18 FDG is in the range of 4-7mSv. A CT will be performed over the thorax to allow attenuation correction of PET images and localisation of tracer uptake. The dose from the thorax CT will be patient dependent but the mean dose to a patient undergoing this type of scan is 2.1mSv. A whole body CT will be performed from the base of the skull to mid-thigh to plan the bed positions for the whole body emission scan and to allow attenuation correction of PET images and localisation of tracer uptake. The dose from the whole body CT will be patient dependent but the mean dose to a patient undergoing this type of scan is 5.2mSv.The total radiation dose participants will be exposed to is in the range of 11.3-14.3mSv. This is equivalent to 4-5.3 years of background radiation to which individuals in the UK are regularly exposed. This would amount to an increased lifetime risk of cancer of approximately 1 in 1250 in a standard population. These risks are compared to a normal lifetime risk of cancer of 1 in 3.
The half-life of F-18 is 110 minutes. The duration of the scan will be up to 120 minutes post injection. The activity within the patient will have reduced by more than 50% through radioactive decay alone by the time they leave the department and will be further reduced by excretion in urine. As with standard clinical administration of F-18, patients will not need to follow any special restrictions once leaving the department.
The CT scanning protocols used in the trial PET-CT are the standard clinical protocols used in the nuclear medicine department and have been developed with a view to minimising the dose to the patient as far as possible. All women of childbearing potential will undergo a pregnancy test on the day of the scan before the injection of the radioactive tracer in order to rule out any risk to a potential foetus. Any woman of childbearing potential who is found to be pregnant or will not consent to a pregnancy test will be excluded from the trial.
Very rarely, individuals may develop an allergic reaction to the PET tracer. No serious adverse reactions to this tracer have been reported. Patients may experience some discomfort from having a needle inserted into their arm/hand in order to have the tracer injected. Occasionally the vein may become inflamed or infected, or they may experience bruising at the insertion site. All efforts will be made to avoid or minimise any discomfort or other adverse effects from these procedures.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Small cohort.
| Arm | Type | Receives |
|---|---|---|
| Breast PET | Experimental | Procedure: F-18 FDG breast PET scanPET imaging of breast with patient in prone position. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female
- Age over 18 (no upper limit).
- Not pregnant.
- Not breastfeeding.
- Indeterminate breast lesion on MRI requiring a second-look ultrasound.
Key exclusion criteria (4 listed)
- Females who are pregnant, planning pregnancy or breastfeeding
- Concurrent and/or recent involvement in other research that is likely to interfere with the intervention within 3 months prior to study enrolment
- Inability to lie flat or undergo the tests.
- Any co-morbidities or conditions which in the opinion of the clinical team means that the patient should be excluded.
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 |
|---|---|---|
| F-18 FDG breast PET scanAlso: MAMMI | Procedure or surgery | Breast PET |
Primary outcome
Recruitment rate
Time frame: Two years.
To assess the feasibility and acceptability to patients of F-18 FDG breast PET scans, by determining how many patients can be recruited over two years.
4 secondary outcomes
Comparison with standard-of-care assessments
Time frame: Two weeks
Eligibility barriers to recruitment
Time frame: Two years.
Comparison with whole-body PET
Time frame: Two weeks
Sample size calculation
Time frame: Two years.
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 24 Mar 2020.
- Individual participant dataSharing planned: Yes. All requests for data sharing will adhere to the UCL Surgical \& Interventional Trials Unit (SITU) data sharing agreement policy. UCL Medical School is supportive of data sharing and will endeavour to assist in requests for data sharing. These data will be held on secure servers and will not be released to any third parties until all the main outputs from the studies have been published. All requests for access to the data will be formally requested through the use of a SITU data request form which will state the purpose, analysis and publication plans together with the named collaborators. All requests are dealt with on a case by case basis by SITU and the Chief Investigator. All requests will be logged and those successful will have a data transfer agreement which will specify appropriate acknowledgement of the Chief Investigator and study group, the sponsor, and funders.
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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.
Thomas Wagner principal investigator
Royal Free Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing F-18 FDG breast PET scan in people with Breast Neoplasm Female, run by University College, 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 4 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 24 Mar 2020. 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?
Recruitment rate (time frame: Two years.). 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 24 Mar 2020.