Clinical trial NCT02972697: Evaluation of 11C-acetate PET Imaging as a Novel Approach to Detecting Pathology in Pulmonary TB
Official title: Evaluation of 11C-acetate PET Imaging as a Novel Approach to Detecting Pathology in Pulmonary TB
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Tuberculosis, Pulmonary
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2016-11-23
Enrollment: 5
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Imaging using 11C-acetate PET (positron emission tomography) in patients with tuberculosis (TB) may be able to detect non-replicating persister bacilli. This may permit identification of those patients at risk of relapse following completion of TB treatment. The main aim of this pilot study is to assess the ability of 11C-acetate PET to detect pulmonary lesions in individuals with active pulmonary TB.

Detailed description: Novel biomarkers for detecting pulmonary TB and response to treatment are sorely needed. PET in conjunction with either CT (computed tomography) or MRI (magnetic resonance imaging) scanning allows assessment of the metabolic activity of lesions as well as the structural anatomy of the lung. The standard radiolabelled tracer for PET is 18F-fluorodeoxyglucose (FDG) which labels metabolically active cells. However, one of the main limitations of FDG is the non-specific uptake leading to difficulty differentiating between tumours, infection and inflammatory pathologies.

11C-acetate is a PET ligand used currently to image various conditions but has not been used to identify TB lesions previously. 11C-acetate may be taken up by the lipid bodies in the dormant bacteria in TB, enabling visualization of this sub-population of bacteria. Using the 11C-acetate ligand for imaging pulmonary TB may add to the utility of PET scanning, potentially allowing monitoring of drug activity against the persister population and identification of those patients who may be at risk of relapse following drug therapy.

This pilot study will compare 11C-acetate to the standard ligand, FDG, using PET/CT and PET/MRI. The target population for this study is those individuals with confirmed pulmonary TB who have a high chance of demonstrable bacillary burden who are therefore likely to have populations of persister bacteria in the lungs.

Eligibility criteria: 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. Tests done at any time during the current episode of TB are acceptable for diagnostic purposes
5. Not on TB treatment or have completed less than 8 weeks 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. History of medical procedures in the last year involving substantial exposure to radiation (\>2mSv)
6. Malignancy requiring chemotherapy or radiation
7. Women who are currently pregnant or breastfeeding

Primary outcomes:
measure: Standard uptake value (SUV) of 11C-acetate PET in pulmonary TB lesions
timeFrame: Within 8 weeks of starting TB treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Nicholas Paton
role: PRINCIPAL_INVESTIGATOR
References: