Evaluation of Somatostatin Receptor Imaging Using PET/MRI as a Novel Approach to Detecting Pathology in Pulmonary TB

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02845570
• Date of registration: 17/07/2016
• Prospective Registration: No
• Primary sponsor: National University Hospital, Singapore
• Public title: Evaluation of Somatostatin Receptor Imaging Using PET/MRI as a Novel Approach to Detecting Pathology in Pulmonary TB
• Scientific title: Evaluation of Somatostatin Receptor Imaging Using PET/MRI as a Novel Approach to Detecting Pathology in Pulmonary TB
• Date of first enrolment: July 2016
• Target sample size: 8
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02845570
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Other. 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

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



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

Health Condition(s) or Problem(s) studied

Tuberculosis

Intervention(s)

Other: 18F-FDG PET/MRI

Other: 68Ga-DOTANOC PET/MRI

Primary Outcome(s)

Standard uptake value (SUV) of 68Ga-DOTANOC in pulmonary TB lesions using PET/MRI [Time Frame: Within 28 days of commencing TB treatment]

Secondary Outcome(s)

Comparison of uptake of 68Ga-DOTANOC with that of 18F-FDG in pulmonary TB. [Time Frame: Within 28 days of commencing TB treatment]

Establishment of optimal timing for a 68Ga-DOTANOC PET scan to evaluate TB lung pathology [Time Frame: Over 90 minutes from injection of tracer]

Secondary ID(s)

DOTANOC TB

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Tan Tock Seng Hospital