Evaluation of 11C-acetate PET Imaging as a Novel Approach to Detecting Pathology in Pulmonary TB

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02972697
• Date of registration: 16/11/2016
• Prospective Registration: No
• Primary sponsor: National University Hospital, Singapore
• Public title: Evaluation of 11C-acetate PET Imaging as a Novel Approach to Detecting Pathology in Pulmonary TB
• Scientific title: Evaluation of 11C-acetate PET Imaging as a Novel Approach to Detecting Pathology in Pulmonary TB
• Date of first enrolment: November 2016
• Target sample size: 5
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02972697
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Singapore

Contacts

• Name: Nicholas Paton
• Affiliation: National University Hospital, Singapore

• Name: Claire Naftalin

Key inclusion & exclusion 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



Age minimum: 21 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Tuberculosis, Pulmonary

Intervention(s)

Radiation: FDG ligand

Radiation: 11C-acetate ligand

Primary Outcome(s)

Standard uptake value (SUV) of 11C-acetate PET in pulmonary TB lesions [Time Frame: Within 8 weeks of starting TB treatment]

Secondary ID(s)

11C_acetate

Source(s) of Monetary Support

Please refer to primary and secondary sponsors