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

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

Sponsors

Lead sponsor: National University Hospital, Singapore

Collaborator: Tan Tock Seng Hospital

Source National University Hospital, Singapore
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.

Overall Status Unknown status
Start Date July 2016
Primary Completion Date August 2017
Phase Phase 1
Study Type Interventional
Primary Outcome
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 Outcome
Measure Time Frame
Comparison of uptake of 68Ga-DOTANOC with that of 18F-FDG in pulmonary TB. Within 28 days of commencing TB treatment
Establishment of optimal timing for a 68Ga-DOTANOC PET scan to evaluate TB lung pathology Over 90 minutes from injection of tracer
Enrollment 8
Condition
Intervention

Intervention type: Other

Intervention name: 68Ga-DOTANOC PET/MRI

Arm group label: 68Ga-DOTANOC PET/MRI

Intervention type: Other

Intervention name: 18F-FDG PET/MRI

Arm group label: 68Ga-DOTANOC PET/MRI

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

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

Gender: All

Minimum age: 21 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Nicholas Paton Principal Investigator National University Hospital, Singapore
Overall Contact

Last name: Claire Naftalin

Phone: (65) 6601 5373

Email: [email protected]

Location
facility status contact
National University Hospital | Singapore, Singapore Recruiting Claire Naftalin (65) 6601 5373 [email protected]
Tan Tock Seng Hospital | Singapore, Singapore Recruiting Sonny YT Wang (65) 6511 5131
Location Countries

Singapore

Verification Date

July 2016

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: 68Ga-DOTANOC PET/MRI

Arm group type: Experimental

Description: Comparison between 68Ga-DOTANOC PET/MRI and 18F-FDG PET/MRI scans

Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov