Tuberculosis
Conditions
Brief summary
Imaging using 68Ga-DOTANOC PET (positron emission tomography) has the potential to detect granulomas in pulmonary tuberculosis, leading to previously unexplored indications for this PET tracer, including identification of subclinical disease in latently infected individuals. This study aims to assess the ability of 68Ga-DOTANOC PET/MRI to detect pulmonary lesions in individuals with active pulmonary tuberculosis.
Detailed description
Granulomas, the hallmark of tuberculosis (TB) infection, have an increased density of somatostatin receptors. Somatostatin analog PET tracers, such as 68Ga-DOTANOC, may be able to identify these pulmonary granulomas. Although currently used for other medical indications, 68Ga-DOTANOC PET scanning has not previously been used to detect TB lesions. This is a pilot study which aims to assess the ability of 68Ga-DOTANOC PET/MRI to detect pulmonary lesions in individuals with active pulmonary tuberculosis. The 68Ga-DOTANOC PET scan and 'standard' 18F-fludeoxyglucose (FDG) PET scan will be compared to enable analysis of differences in uptake between these tracers in terms of number, size and distribution of lesions. Demonstrating the clinical utility of 68Ga-DOTANOC in active pulmonary TB is necessary prior to using this PET tracer to further explore other potential uses in TB such as identifying individuals with latent TB who are at risk of progressing to active TB, measuring therapeutic response to TB treatment and identifying extrapulmonary lesions.
Interventions
OTHER68Ga-DOTANOC PET/MRI
OTHER18F-FDG PET/MRI
Sponsors
Tan Tock Seng Hospital
National University Hospital, Singapore
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 21 years and above 2. Willing to comply with the study visits and procedures 3. Willing and able to provide written informed consent 4. Clinical diagnosis of pulmonary TB with characteristic symptoms and compatible X-ray findings plus microbiological confirmation with one or more of (i) Acid fast bacilli (AFB) smear-positive or (ii) molecular test positive or (iii) TB culture positive 5. Not on TB treatment or have completed less than 28 days of TB treatment
Exclusion criteria
1. Diabetes that is, in the judgment of the investigator, so poorly controlled that it would prevent adequate PET scanning 2. Cardiac pacemaker, aneurysm clip or other metallic implant considered unsafe for MRI 3. Known chronic kidney disease 4. Occupation involving substantial exposure to radiation 5. Malignancy requiring chemotherapy or radiation 6. Women who are currently pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Standard uptake value (SUV) of 68Ga-DOTANOC in pulmonary TB lesions using PET/MRI | Within 28 days of commencing TB treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of uptake of 68Ga-DOTANOC with that of 18F-FDG in pulmonary TB. | Within 28 days of commencing TB treatment | Different uptake values between and within the pulmonary lesions will be measured and compared between the 2 tracers. |
| Establishment of optimal timing for a 68Ga-DOTANOC PET scan to evaluate TB lung pathology | Over 90 minutes from injection of tracer | The net tracer uptake rate for 68Ga-DOTANOC (Ki) will be derived from kinetic analysis in combination with dynamic imaging and the relationship between SUV and Ki. |
Countries
Singapore
Contacts
Primary ContactClaire Naftalin
Outcome results
None listed