Tuberculosis, PulmonaryPhase 1NCT02967666
Evaluation of PET/MRI Using a Somatostatin Analog Tracer as a Novel Approach to Detecting Pathology in High Risk TB-exposed Contacts
A Phase 1 study testing FDG ligand and DOTANOC ligand in people with Tuberculosis, Pulmonary, run by National University Hospital, Singapore at 2 sites in Singapore.
Trial summary
PET/MRI (positron emission tomography/magnetic resonance imaging) with somatostatin analog tracers has the potential to provide an imaging technique targeting subclinical granulomatous disease in those with latent tuberculosis (TB), allowing identification of individuals who may be at risk of progression to active TB. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Tuberculosis, Pulmonary
- What is being tested?
- FDG ligand and DOTANOC ligand
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSingapore
- Study dates
- Nov 2016to May 2017
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 years or over
- Close household contact of any patient with newly-diagnosed (within last 2 months) smear positive pulmonary TB (close contact defined as sleeping in the same house for at least one month with a TB patient prior to start of treatment).
- Interferon Gamma Release Assay (IGRA) positive
- Willing to comply with the study visits and procedures
- Willing and able to provide written informed consent
Who cannot join
- Previous treatment for TB disease
- Diabetes that is, in the judgment of the investigator, so poorly controlled that it would prevent adequate PET scanning
- Cardiac pacemaker, aneurysm clip or other metallic implant considered unsafe for MRI
- Occupation involving substantial exposure to radiation
- Malignancy requiring chemotherapy or radiation
- Known lung disease which may affect interpretation of the scan
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- Known chronic kidney disease
- Symptoms, signs and/or previous investigations suggestive of active TB in the opinion of the investigator (cough for >1 month, cough productive of sputum or blood, shortness of breath, weight loss, night sweats, fever, abnormal examination, chest X-ray findings)
- Women who are currently pregnant or breastfeeding
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites, 2 recruiting
- Recruiting
National University Hospital
Singapore
Claire Naftalin, (65) 6601 5373, claire_naftalin@nuhs.edu.sg
- Recruiting
Tan Tock Seng Hospital
Singapore
Sonny YT Wang, (65) 6511 5131
About this study
PET/MRI (positron emission tomography/magnetic resonance imaging) with somatostatin analog tracers has the potential to provide an imaging technique targeting subclinical granulomatous disease in those with latent tuberculosis (TB), allowing identification of individuals who may be at risk of progression to active TB.
Read the detailed description
Granulomas, the hallmark of TB infection, have an increased density of somatostatin receptors. Somatostatin analog PET tracers, such as 68Ga-DOTANOC, bind to somatostatin receptors and are able to detect pulmonary TB lesions using PET/MRI. This study aims to better understand the pathology of the spectrum of latent TB using 68Ga-DOTANOC PET/MRI imaging, identifying individuals with subclinical pulmonary TB who may be at risk of progressing to active TB.
Currently, biomarkers to identify those who are at risk of developing active TB are limited. Non-invasive biomarkers for pulmonary lesions are sorely needed and imaging with 68Ga-DOTANOC PET/MRI provides an opportunity to detect subclinical pulmonary disease in those who have been in close contact with smear-positive pulmonary TB.
- Conditions
- Tuberculosis, Pulmonary
- Being tested
- FDG ligand, DOTANOC ligand
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG ligandRadiation
Also called 18F-Fludeoxyglucose
DOTANOC ligandRadiation
Also called 68Ga-DOTANOC
| Study group | Role | What they receive |
|---|---|---|
| FDG PET/MRI, DOTANOC PET/MRI | Experimental | FDG PET/MRI and DOTANOC PET/MRI will be performed. Receives: Radiation: FDG ligand; Radiation: DOTANOC ligand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard uptake value (SUV) of 68Ga-DOTANOC in subclinical TB using PET/MRI
Measured: Within 2 months of exposure to smear-positive pulmonary TB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, PulmonaryStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas Paton, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967666
- Sponsor's protocol ID
- DOTANOC_contacts
- Status last verified
- Nov 2016
- First submitted
- 16 Nov 2016
- Last updated
- 18 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of PET/MRI Using a Somatostatin Analog Tracer as a Novel Approach to Detecting Pathology in High Risk TB-exposed Contacts
- ClinicalTrials.gov ID
- NCT02967666
- Acronym / sponsor ID
- DOTANOC_contacts
- Conditions
- Tuberculosis, Pulmonary
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- May 2017 (estimated)
- First posted
- 18 Nov 2016 (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.
PET/MRI (positron emission tomography/magnetic resonance imaging) with somatostatin analog tracers has the potential to provide an imaging technique targeting subclinical granulomatous disease in those with latent tuberculosis (TB), allowing identification of individuals who may be at risk of progression to active TB.
Detailed description
Granulomas, the hallmark of TB infection, have an increased density of somatostatin receptors. Somatostatin analog PET tracers, such as 68Ga-DOTANOC, bind to somatostatin receptors and are able to detect pulmonary TB lesions using PET/MRI. This study aims to better understand the pathology of the spectrum of latent TB using 68Ga-DOTANOC PET/MRI imaging, identifying individuals with subclinical pulmonary TB who may be at risk of progressing to active TB.
Currently, biomarkers to identify those who are at risk of developing active TB are limited. Non-invasive biomarkers for pulmonary lesions are sorely needed and imaging with 68Ga-DOTANOC PET/MRI provides an opportunity to detect subclinical pulmonary disease in those who have been in close contact with smear-positive pulmonary TB.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FDG PET/MRI, DOTANOC PET/MRI | Experimental | Radiation: FDG ligand, Radiation: DOTANOC ligandFDG PET/MRI and DOTANOC PET/MRI will be performed. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 21 years or over
- Close household contact of any patient with newly-diagnosed (within last 2 months) smear positive pulmonary TB (close contact defined as sleeping in the same house for at least one month with a TB patient prior to start of treatment).
- Interferon Gamma Release Assay (IGRA) positive
- Willing to comply with the study visits and procedures
- Willing and able to provide written informed consent
Key exclusion criteria (9 listed)
- Previous treatment for TB disease
- Diabetes that is, in the judgment of the investigator, so poorly controlled that it would prevent adequate PET scanning
- Cardiac pacemaker, aneurysm clip or other metallic implant considered unsafe for MRI
- Occupation involving substantial exposure to radiation
- Malignancy requiring chemotherapy or radiation
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 |
|---|---|---|
| FDG ligandAlso: 18F-Fludeoxyglucose | Radiation | FDG PET/MRI, DOTANOC PET/MRI |
| DOTANOC ligandAlso: 68Ga-DOTANOC | Radiation | FDG PET/MRI, DOTANOC PET/MRI |
Primary outcome
Standard uptake value (SUV) of 68Ga-DOTANOC in subclinical TB using PET/MRI
Time frame: Within 2 months of exposure to smear-positive pulmonary TB
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2016.
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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.
Nicholas Paton principal investigator
National University Hospital, Singapore
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 FDG ligand and DOTANOC ligand in people with Tuberculosis, Pulmonary, run by National University Hospital, Singapore at 2 sites in Singapore.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 18 Nov 2016. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire Naftalin ((65) 6601 5373, claire_naftalin@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard uptake value (SUV) of 68Ga-DOTANOC in subclinical TB using PET/MRI (time frame: Within 2 months of exposure to smear-positive pulmonary TB). 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 18 Nov 2016.