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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 November 2016 |
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Main ID: |
NCT02967666 |
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Date of registration:
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16/11/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of PET/MRI Using a Somatostatin Analog Tracer as a Novel Approach to Detecting Pathology in High Risk TB-exposed Contacts
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Scientific title:
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Evaluation of PET/MRI Using a Somatostatin Analog Tracer as a Novel Approach to Detecting Pathology in High Risk TB-exposed Contacts |
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Date of first enrolment:
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November 2016 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02967666 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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Phase 1
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Countries of recruitment
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Singapore
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Contacts
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Name:
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Claire Naftalin |
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Address:
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Telephone:
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(65) 6601 5373 |
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Email:
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claire_naftalin@nuhs.edu.sg |
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Affiliation:
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Name:
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Nicholas Paton |
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Address:
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Telephone:
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Email:
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Affiliation:
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National University Hospital, Singapore |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age 21 years or over
2. 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).
3. Interferon Gamma Release Assay (IGRA) positive
4. Willing to comply with the study visits and procedures
5. Willing and able to provide written informed consent
Exclusion Criteria:
1. Previous treatment for TB disease
2. Diabetes that is, in the judgment of the investigator, so poorly controlled that it
would prevent adequate PET scanning
3. Cardiac pacemaker, aneurysm clip or other metallic implant considered unsafe for MRI
4. Occupation involving substantial exposure to radiation
5. Malignancy requiring chemotherapy or radiation
6. Known lung disease which may affect interpretation of the scan
7. Known chronic kidney disease
8. 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)
9. Women who are currently pregnant or breastfeeding
Age minimum:
21 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Tuberculosis, Pulmonary
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Intervention(s)
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Radiation: FDG ligand
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Radiation: DOTANOC ligand
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Primary Outcome(s)
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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]
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Secondary ID(s)
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DOTANOC_contacts
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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