Arthritis, RheumatoidPhase 1NCT02350426

A Study to Assess Inflammation in Rheumatoid Arthritis Using Molecular Imaging Techniques

A Phase 1 study testing Gadobutrol, 18F-FDG and 18F-GE-180 in people with Arthritis, Rheumatoid, run by GlaxoSmithKline at 2 sites in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 30 to 85 years
Conditions the study is for: Arthritis, Rheumatoid
What is being tested?: Gadobutrol, 18F-FDG and 18F-GE-180
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 2 sitesUnited Kingdom
Study dates: 12 Aug 2015to 26 Oct 2016
Phase: Phase 1
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 30 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects must be aged between 30 and 85 years inclusive at the time of signing the consent form.
Stable, moderate to severe RA, based on either the 1987 American College of Rheumatology definition or the 2010 American College of Rheumatology/ European league Against Rheumatism (ACR/EULAR) classification criteria for RA (functional classes II and II).
Disease activity score (DAS)28-erythrocyte sedimentation rate >3.2 at screening.
Patients with at least one painful and swollen wrist or knee joint as assessed by a rheumatologist.
Male subjects are eligible for enrolment in the study OR female subjects of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy (for this definition, "documented" refers to the outcome of the investigator's/designee's review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records) or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 milli international unit per milliliter (MIU/mL) and estradiol <40 picogram/mL (pg/mL) (<147 picomole per liter [pmol/L]) is confirmatory). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use two of the contraception methods listed in the protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method OR female subjects of child-bearing potential with negative pregnancy test as determined by serum human chorionic gonadotropin (hCG) test at screening and 4-7 days prior to dosing and agrees to use two different contraception methods listed in the protocol. Use must be established a minimum of 1 month prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception from at least one month prior to the first dose through to follow up. Contraception requirements do not apply to women with only same-sex partners, when this is their preferred and usual lifestyle or for subjects who are and will continue to be abstinent from penile-vaginal intercourse on a long term and persistent basis.
Subjects must be capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Who cannot join

Subjects who meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematosus).
Subjects with current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac (including ischemic heart disease), neurological, or cerebral disease, or other medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study.
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude.
Patients not on stable medication for RA for at least 4 weeks prior to screening.
Subjects receiving treatment with biologics will not be eligible for inclusion.

Show all 21Show fewer

Subjects exceeding 159 kilogram (kg) body weight.
Subjects exceeding 195 centimeter (cm) in height.
History of regular alcohol consumption within 6 months of the study, defined as an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 gram of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
History of sensitivity to any of the study procedures or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
Subjects with creatinine clearance levels <60 milliliter per minute (mL/min).
A positive pre-study alcohol screen (alcohol breath test).
Pregnant females as determined by positive serum HCG test at screening or prior to imaging-related procedures.
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
Lactating females.
Exposure to more than four new chemical entities within 12 months prior to the first imaging-related procedures.
Previous inclusion in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden (a significant radiation burden being defined as 10 milliSievert [mSv] in addition to natural background radiation, in the previous 3 years including the dose from this study).
History of, or suffers from, claustrophobia or feel that they will be unable to lie still in the PET or MRI scanner for a period of 1-2 hours or fit in the PET or MRI scanner due to body size.
Contraindication to MRI scanning (as assessed by local MRI safety questionnaire) which includes, but is not limited to, intracranial aneurysm clips or other metallic objects, history of intra-orbital metal fragments that have not been removed by a medical doctor MD), presence of a cardiac pacemaker, non-magnetic resonance (MR) compatible heart valves or other electronic device or ferromagnetic metal foreign bodies, inner ear implants or history of cancer in first degree relatives diagnosed before age of 55.
Presence of Ala147Thr polymorphism in translocator protein (TSPO) (which confers low affinity binding of 18F-GE-180) following confirmation by genotyping assay.
Subjects receiving treatment with Disulfiram.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

GSK Investigational Site
Cambridge, Cambridgeshire, CB2 0QQ
GSK Investigational Site
Cambridge, CB2 2GG

Other trials in United Kingdom

About this study

Official title: An Adaptive Design Open Label Pilot Study in Rheumatoid Arthritis Patients to Assess Inflammation Using Molecular Imaging Techniques

This is an adaptive Positron Emission Tomography/ Computed Tomography (PET/CT) and Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) open-label study design for the investigation of inflammation in adult rheumatoid arthritis (RA) patients, not involving therapeutic intervention. Each study participant will undergo two half body PET/CT scans from the pelvis to the bottom of the feet (including hands and wrists) with an additional bed position centred on the shoulders. One scan will be conducted with 18F-FDG and the other with 18F-GE-180. The first PET/CT scan (PET1) will be performed 4 weeks (28 +/- 2 days) after the first screening visit, whereas the second PET/CT scan (PET2) will be carried out within 2 weeks (7 +/- 7 days) after PET1. The order of PET/CT scans for each subject will be based on a computer generated randomisation schedule after the screening visit. A sub-group of study participants will be invited to undergo an additional dynamic 18F-GE-180 PET scan of a selected joint (knee or wrist) prior to their 18F-GE-180 PET/CT half body scan. The primary objective of the study is to quantify inflammation in joints of RA patients by determining 18F-FDG and 18F-GE-180 uptake using PET, and DCE-MRI parameters.

Conditions: Arthritis, Rheumatoid
Being tested: Gadobutrol, 18F-FDG, 18F-GE-180
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GadobutrolOther
Gadobutrol is a solution for intravenous (IV) injection in prefilled syringe/cartridge with a unit dose strength of 1.0 millimole (mmol)/mL solution, and will be administered at up to 0.1mmol/kg.
18F-FDGOther
18F-FDG is a solution for IV injection in multidose vial, maximum 10 mL with unit dose strength of 160 megabecquerel (MBq) at maximum.
18F-GE-180Other
18F-GE-180 solution for IV injection in 10mL glass vial. Patients will receive a maximum activity of 195 MBq in a maximum volume of 10 mL (bolus) of 18F-GE-180, containing not more than 2 microgram (mcg)/mL 18F-GE-180 (20 mcg for a 10 mL dose).

Study groups in NCT02350426
Study group	Role	What they receive
Arm 1	Experimental	As per randomization schedule, subjects will undergo two half body PET/CT scans (PET/CT1 and PET/CT2). During visit 1 subject will undergo PET/CT1 scan with 18F-FDG followed by PET/CT2 scan with 18F-GE-180 in visit 2. A sub-group of patients will participate in an additional dynamic PET/CT scan with 18F-GE-180 prior to their 18F-GE-180 PET/CT half body scan. Receives: Other: Gadobutrol; Other: 18F-FDG; Other: 18F-GE-180
Arm 2	Experimental	As per randomization schedule, , subjects will undergo two half body PET/CT scans (PET/CT1 and PET/CT2). During visit 1 subject will undergo PET/CT1 scan with 18F-GE-180 followed by PET/CT2 scan with 18F-FDG in visit 2. A sub-group of patients will participate in an additional dynamic PET/CT scan with 18F-GE-180 prior to their 18F-GE-180 PET/CT half body scan. Receives: Other: Gadobutrol; Other: 18F-FDG; Other: 18F-GE-180

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluator's assessment of image quality and potential to define abnormality
Half body and shoulder images from 18F-FDG and 18F-GE-180 will be visually inspected by two nuclear medicine physicians with respect to the clarity and ease of identifying abnormal high uptake in joints suspected to have inflammation. A subjective scale of abnormality will be applied to each image as follows: 3 = excellent quality; 2 = intermediate quality; 1 = poor quality but still interpretable; 0 = poor quality, not interpretable.
Measured: Week 8
Standardised Uptake Value (SUV) of 18F-FDG and 18F-GE-180
SUV will be derived from PET static imaging for 18F-FDG and 18F-GE-180 in selected joints. Using normalisation by weight and body surface area, SUVmax, SUVpeak and SUVmean (average of voxel values above a 75% iso-contour of SUVmax) will be calculated within the joint volume.
Measured: Week 8
Tissue-to-reference Ratio (TR) of 18F-FDG and 18F-GE-180
TR will be derived from PET static imaging for 18F-FDG and 18F-GE-180 in selected joints. TR will be determined using the mean image value within each joint volume, and either the blood concentration decay-corrected to the start of the PET acquisition or the mean image value within non-inflamed muscle as reference.
Measured: Week 8
Total Inflammatory Volume (TIV) of 18F-FDG and 18F-GE-180
TIV will be derived from PET static imaging for 18F-FDG and 18F-GE-180 in selected joints.
Measured: Week 8
Exchange Rate (Ktrans)
Ktrans will be derived from DCE-MRI in selected joints
Measured: Week 8
Interstitial Volume (Ve)
Ve will be derived from DCE-MRI in selected joints
Measured: Week 8
Initial Rate of Enhancement (IRE)
IRE will be derived from DCE-MRI in selected joints
Measured: Week 8
Maximal Signal Intensity Enhancement (ME)
ME will be derived from DCE-MRI in selected joints
Measured: Week 8

Secondary outcomes (4)

Visual assessment of static 18F-FDG and 18F-GE-180 images using a 4-point visual analysis scale and abnormal joint counts
18F-FDG and 18F-GE-180 static images will be evaluated by experienced observers with respect to the ease of identifying high uptake in joints suspected to have inflammation. Images will be assessed on the basis of a 4-point visual scale of abnormality/discernibility (0=poor quality - 4=excellent quality) and the number of abnormal joints will be counted.
Measured: Week 8
PET static imaging parameters (SUV, TR and TIV) of 18F-FDG and 18F-GE-180 in selected joints
The correlation between PET static imaging parameters (SUV, TR and TIV) of 18F-FDG and 18F-GE-180 will be determined
Measured: Week 8
18F-GE-180 radio-PK modelling indices (total distribution volume; VT) and 18F-GE-180 static imaging metrics (SUV, TR and TIV)
In order to verify static imaging parameters for scans, the pharmacokinetic profile of 18F-GE-180 will be determined, using dynamic PET scanning, blood sampling and HPLC analysis in a sub-cohort of RA study patients. 18F-GE-180 radio-PK parameters will be correlated with 18F-GE-180 static imaging metrics (SUV, TR and TIV)
Measured: Week 8
Adverse events (AEs) and serious adverse events (SAEs) assessment
Number of AEs and SAEs as a measure of safety and tolerability of 18F-GE-180 and 18F-FDG
Measured: Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Aug 201526 Oct 2016

First posted29 Jan 2015 (estimated)
Study start12 Aug 2015
Primary completion26 Oct 2016
Study completion26 Oct 2016

Why it stopped: A decision to stop the study was made by the site and GSK project team based on pre-defined stopping criteria in the protocol

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02350426
Sponsor's protocol ID: 201659
Status last verified: Dec 2017
First submitted: 15 Dec 2014
Last updated: 4 Dec 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Adaptive Design Open Label Pilot Study in Rheumatoid Arthritis Patients to Assess Inflammation Using Molecular Imaging Techniques
ClinicalTrials.gov ID: NCT02350426
Acronym / sponsor ID: 201659
Conditions: Arthritis, Rheumatoid
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: A decision to stop the study was made by the site and GSK project team based on pre-defined stopping criteria in the protocol
Enrolment: 10 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Collaborators: Cambridge University Hospitals NHS Foundation Trust
Study start: 12 Aug 2015 (actual)
Primary completion: 26 Oct 2016 (actual)
Study completion: 26 Oct 2016 (actual)
First posted: 29 Jan 2015 (estimated)
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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm 1	Experimental	Other: Gadobutrol, Other: 18F-FDG, Other: 18F-GE-180As per randomization schedule, subjects will undergo two half body PET/CT scans (PET/CT1 and PET/CT2). During visit 1 subject will undergo PET/CT1 scan with 18F-FDG followed by PET/CT2 scan with 18F-GE-180 in visit 2. A sub-group of patients will participate in an additional dynamic PET/CT scan with 18F-GE-180 prior to their 18F-GE-180 PET/CT half body scan.
Arm 2	Experimental	Other: Gadobutrol, Other: 18F-FDG, Other: 18F-GE-180As per randomization schedule, , subjects will undergo two half body PET/CT scans (PET/CT1 and PET/CT2). During visit 1 subject will undergo PET/CT1 scan with 18F-GE-180 followed by PET/CT2 scan with 18F-FDG in visit 2. A sub-group of patients will participate in an additional dynamic PET/CT scan with 18F-GE-180 prior to their 18F-GE-180 PET/CT half body scan.

Who may qualify

Ages: 30 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Subjects must be aged between 30 and 85 years inclusive at the time of signing the consent form.
Stable, moderate to severe RA, based on either the 1987 American College of Rheumatology definition or the 2010 American College of Rheumatology/ European league Against Rheumatism (ACR/EULAR) classification criteria for RA (functional classes II and II).
Disease activity score (DAS)28-erythrocyte sedimentation rate >3.2 at screening.
Patients with at least one painful and swollen wrist or knee joint as assessed by a rheumatologist.
Male subjects are eligible for enrolment in the study OR female subjects of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy (for this definition, "documented" refers to the outcome of the investigator's/designee's review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records) or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 milli international unit per milliliter (MIU/mL) and estradiol <40 picogram/mL (pg/mL) (<147 picomole per liter [pmol/L]) is confirmatory). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use two of the contraception methods listed in the protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method OR female subjects of child-bearing potential with negative pregnancy test as determined by serum human chorionic gonadotropin (hCG) test at screening and 4-7 days prior to dosing and agrees to use two different contraception methods listed in the protocol. Use must be established a minimum of 1 month prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception from at least one month prior to the first dose through to follow up. Contraception requirements do not apply to women with only same-sex partners, when this is their preferred and usual lifestyle or for subjects who are and will continue to be abstinent from penile-vaginal intercourse on a long term and persistent basis.

Key exclusion criteria (21 listed)

Subjects who meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematosus).
Subjects with current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac (including ischemic heart disease), neurological, or cerebral disease, or other medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study.
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude.
Patients not on stable medication for RA for at least 4 weeks prior to screening.

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
GadobutrolGadobutrol is a solution for intravenous (IV) injection in prefilled syringe/cartridge with a unit dose strength of 1.0 millimole (mmol)/mL solution, and will be administered at up to 0.1mmol/kg.	Other	Arm 1, Arm 2
18F-FDG18F-FDG is a solution for IV injection in multidose vial, maximum 10 mL with unit dose strength of 160 megabecquerel (MBq) at maximum.	Other	Arm 1, Arm 2
18F-GE-18018F-GE-180 solution for IV injection in 10mL glass vial. Patients will receive a maximum activity of 195 MBq in a maximum volume of 10 mL (bolus) of 18F-GE-180, containing not more than 2 microgram (mcg)/mL 18F-GE-180 (20 mcg for a 10 mL dose).	Other	Arm 1, Arm 2

Primary outcome

Evaluator's assessment of image quality and potential to define abnormality
Time frame: Week 8
Half body and shoulder images from 18F-FDG and 18F-GE-180 will be visually inspected by two nuclear medicine physicians with respect to the clarity and ease of identifying abnormal high uptake in joints suspected to have inflammation. A subjective scale of abnormality will be applied to each image as follows: 3 = excellent quality; 2 = intermediate quality; 1 = poor quality but still interpretable; 0 = poor quality, not interpretable.
Standardised Uptake Value (SUV) of 18F-FDG and 18F-GE-180
Time frame: Week 8
SUV will be derived from PET static imaging for 18F-FDG and 18F-GE-180 in selected joints. Using normalisation by weight and body surface area, SUVmax, SUVpeak and SUVmean (average of voxel values above a 75% iso-contour of SUVmax) will be calculated within the joint volume.
Tissue-to-reference Ratio (TR) of 18F-FDG and 18F-GE-180
Time frame: Week 8
TR will be derived from PET static imaging for 18F-FDG and 18F-GE-180 in selected joints. TR will be determined using the mean image value within each joint volume, and either the blood concentration decay-corrected to the start of the PET acquisition or the mean image value within non-inflamed muscle as reference.
Total Inflammatory Volume (TIV) of 18F-FDG and 18F-GE-180
Time frame: Week 8
TIV will be derived from PET static imaging for 18F-FDG and 18F-GE-180 in selected joints.
Exchange Rate (Ktrans)
Time frame: Week 8
Ktrans will be derived from DCE-MRI in selected joints
Interstitial Volume (Ve)
Time frame: Week 8
Ve will be derived from DCE-MRI in selected joints
Initial Rate of Enhancement (IRE)
Time frame: Week 8
IRE will be derived from DCE-MRI in selected joints
Maximal Signal Intensity Enhancement (ME)
Time frame: Week 8
ME will be derived from DCE-MRI in selected joints

4 secondary outcomes

Visual assessment of static 18F-FDG and 18F-GE-180 images using a 4-point visual analysis scale and abnormal joint counts
Time frame: Week 8
PET static imaging parameters (SUV, TR and TIV) of 18F-FDG and 18F-GE-180 in selected joints
Time frame: Week 8
18F-GE-180 radio-PK modelling indices (total distribution volume; VT) and 18F-GE-180 static imaging metrics (SUV, TR and TIV)
Time frame: Week 8
Adverse events (AEs) and serious adverse events (SAEs) assessment
Time frame: Week 8

Results and safety

The study was stopped early (reason given: A decision to stop the study was made by the site and GSK project team based on pre-defined stopping criteria in the protocol). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2017.

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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.

GSK Clinical Trials study director

GlaxoSmithKline

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Gadobutrol, 18F-FDG and 18F-GE-180 in people with Arthritis, Rheumatoid, run by GlaxoSmithKline at 2 sites 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 6 inclusion and 21 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: stopped early, as of the sponsor's last update on 4 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

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?

Evaluator's assessment of image quality and potential to define abnormality (time frame: Week 8). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02350426.

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 4 Dec 2017.