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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02967666
Other study ID # DOTANOC_contacts
Secondary ID
Status Recruiting
Phase Phase 1
First received November 16, 2016
Last updated November 16, 2016
Start date November 2016

Study information

Verified date November 2016
Source National University Hospital, Singapore
Contact Claire Naftalin
Phone (65) 6601 5373
Email claire_naftalin@nuhs.edu.sg
Is FDA regulated No
Health authority Singapore: Domain Specific Review BoardsSingapore: Health Sciences Authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Radiation:
FDG ligand

DOTANOC ligand


Locations

Country Name City State
Singapore National University Hospital Singapore
Singapore Tan Tock Seng Hospital Singapore

Sponsors (1)

Lead Sponsor Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary Standard uptake value (SUV) of 68Ga-DOTANOC in subclinical TB using PET/MRI Within 2 months of exposure to smear-positive pulmonary TB No
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