Evaluation of 11C-acetate PET Imaging as a Novel Approach to Detecting Pathology in Pulmonary TB
Primary Purpose
Tuberculosis, Pulmonary
Status
Unknown status
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
11C-acetate ligand
FDG ligand
Sponsored by
About this trial
This is an interventional diagnostic trial for Tuberculosis, Pulmonary
Eligibility Criteria
Inclusion Criteria:
- Age 21 years and above
- Willing to comply with the study visits and procedures
- Willing and able to provide written informed consent
- 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
- Not on TB treatment or have completed less than 8 weeks of TB treatment
Exclusion Criteria:
- 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
- Known chronic kidney disease
- Occupation involving substantial exposure to radiation
- History of medical procedures in the last year involving substantial exposure to radiation (>2mSv)
- Malignancy requiring chemotherapy or radiation
- Women who are currently pregnant or breastfeeding
Sites / Locations
- National University HospitalRecruiting
- Tan Tock Seng HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
11C-acetate PET
Arm Description
11C-acetate and FDG PET/MRI and PET/CT will be performed.
Outcomes
Primary Outcome Measures
Standard uptake value (SUV) of 11C-acetate PET in pulmonary TB lesions
Secondary Outcome Measures
Full Information
NCT ID
NCT02972697
First Posted
November 16, 2016
Last Updated
April 12, 2017
Sponsor
National University Hospital, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT02972697
Brief Title
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
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis, Pulmonary
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
11C-acetate PET
Arm Type
Experimental
Arm Description
11C-acetate and FDG PET/MRI and PET/CT will be performed.
Intervention Type
Radiation
Intervention Name(s)
11C-acetate ligand
Intervention Type
Radiation
Intervention Name(s)
FDG ligand
Primary Outcome Measure Information:
Title
Standard uptake value (SUV) of 11C-acetate PET in pulmonary TB lesions
Time Frame
Within 8 weeks of starting TB treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 21 years and above
Willing to comply with the study visits and procedures
Willing and able to provide written informed consent
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
Not on TB treatment or have completed less than 8 weeks of TB treatment
Exclusion Criteria:
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
Known chronic kidney disease
Occupation involving substantial exposure to radiation
History of medical procedures in the last year involving substantial exposure to radiation (>2mSv)
Malignancy requiring chemotherapy or radiation
Women who are currently pregnant or breastfeeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claire Naftalin
Phone
(65) 6601 5373
Email
claire_naftalin@nuhs.edu.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Paton
Organizational Affiliation
National University Hospital, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Naftalin
Phone
(65) 6601 5373
Email
claire_naftalin@nuhs.edu.sg
Facility Name
Tan Tock Seng Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonny YT Wang
Phone
(65) 6511 5131
12. IPD Sharing Statement
Learn more about this trial
Evaluation of 11C-acetate PET Imaging as a Novel Approach to Detecting Pathology in Pulmonary TB
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